🔍 RecallPedia

BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784

Class I - Dangerous
🏥 Medical Devices Recalled: March 11, 2025 Bard Access Systems Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    REF/UDI-DI/Lot(Expiration): 3174155/00801741027611/REGQ0844(6/30/2025), REGZ1439(11/30/2025), REHP0860(11/30/2025), REHQ3097(6/30/2026), REHR0022(6/30/2026), REHT1151(7/31/2026), REHU1525(11/30/2026), REHU2455(6/30/2026), REHU2614(11/30/2026), REHV2765 (7/31/2026), REJN3472(2/28/2027), REJP4216(5/31/2027), REJQ2272(7/31/2027), REJR1411(8/31/2027), REJR2565(4/30/2027), REJR2614(8/31/2027), REJT0755(9/30/2027); CK000540/00801741105142/REGZ1425(10/31/2025), REHP0808(11/30/2025), REHU1513(1/31/2026), REHV2221(1/31/2026), REHY2842(10/31/2026), REJN4145 (12/31/2026), REJR1322(3/31/2027), REJS2110(4/30/2027), REJS3773(2/28/2027); 3174118/00801741027598/REGZ2512(11/30/2025), REHP1760(1/31/2026), REHP2603(1/31/2026), REJN1059(12/31/2026); CK000483/00801741099397/REHN3187(10/31/2025), REHQ1804(6/30/2026), REJN1065(5/31/2027), REJP2018(6/30/2027), REJR1321(8/31/2027); 3174335/00801741027628/REHN3908(10/31/2025), REHP0800(10/31/2025), REHQ3070(11/30/2025), REHT1129(5/31/2026), REHU1519(6/30/2026), REHV1391(7/31/2026), REHV3050(7/31/2026), REHZ1011(11/30/2026), REJN4109(12/31/2026), REJQ0405(2/28/2027), REJR2090(3/31/2027), REJT0833(5/31/2027); 3174355/00801741027635/REHQ1781(11/30/2025), REHS1925(4/30/2026), REHT1120(5/31/2026), REHU0975(6/30/2026), REHU2488(6/30/2026), REHV1400(7/31/2026), REHV3020(7/31/2026), REHW1329(8/31/2026), REHY1684(10/31/2026), REHZ1903(11/30/2026), REJN3007(12/31/2026), REJP0855(1/31/2027), REJP2021(1/31/2027), REJQ2284(2/28/2027), REJR2157(3/31/2027), REJS2171(4/30/2027), REJS4490(4/30/2027); CK000196/00801741028847/REHQ3064(6/30/2026), REHT2954(1/31/2026), REHX2926(12/31/2026), REHZ1873(3/31/2027), REJQ2279(8/31/2027); 9174118/00801741035562/REHQ3091(6/30/2026), REHR0017(6/30/2026), REHT1132(6/30/2026), REHU2496(6/30/2026), REHY2811(2/28/2026), REHZ1882(3/31/2027); CK000955/00801741200922/REHQ4029(11/30/2025), REHV2232(2/28/2026), REHX2916(12/31/2025), REHY3954(7/31/2026), REJN2995(9/30/2025); 3174135/00801741027604/REHR0003(11/30/2025), REHS4184(7/31/2026), REHU2356(11/30/2026), REHU2612(6/30/2026), REJS2089(9/30/2027); CK000617/00801741122286/REHS1001(9/30/2025), REJQ2280(2/28/2027); CK000839/00801741154393/REHS4241(4/30/2026), REHV3026(7/31/2026), REHX2908(9/30/2026), REHY2826(10/31/2026), REJN3000(12/31/2026), REJS3479(4/30/2027); 3194355/00801741027789/REHT2157(5/31/2025), REHT2967(5/31/2025), REHU3317(6/30/2025), REHV3031(7/31/2025), REHY3957(10/31/2025), REHZ1878(11/30/2025), REJN3008(12/31/2025), REJR1276(12/31/2025), REJR2062(3/31/2026), REJS2065(12/31/2025); 6174118/00801741139017/REHT2984(1/31/2026); 3194135/00801741027758/REHU1029(5/31/2025), REHY1636(10/31/2025), REHY2820(10/31/2025), REJN2980(12/31/2025); 3194335/00801741027772/REHU1430(6/30/2025), REHU2339(6/30/2025), REHW1354(8/31/2025), REHY2700(10/31/2025), REHZ1026(10/31/2025), REJN1463(12/31/2025), REJN3016(12/31/2025), REJR2013(3/31/2026), REJS3853(12/31/2025); 2174108/00801741138966/REHU3327(9/30/2025); 9194118/00801741028618/REHV0263(6/30/2025), REJQ0411(1/31/2026); 3194118/00801741027741REHY1654(10/31/2025), REJP0843(5/31/2025), REJS0206(3/31/2026); 1174118/00801741034466/REHY2815(5/31/2025), REJN1443(8/31/2025), REJQ0415(5/31/2025), REJQ2243(8/31/2025), REJS4488(10/31/2025); CK000285C/00801741161117/REHZ1477(5/31/2025), REJN2365(5/31/2025), REJQ2812(8/31/2025), REJR2208(9/30/2025), REJS1287(9/30/2025), REJS4740(10/31/2025); CK000335A/00801741101281/REHZ1620(5/31/2025), REJN2425(6/30/2025), REJQ0819(8/31/2025), REJQ1491(8/31/2025); CK000796/00801741144783/REHZ1625(5/31/2025), REJQ1521(8/31/2025), REJR1458(9/30/2025), REJS0258(9/30/2025), REJS3583(10/31/2025), REJT0877(11/30/2025), REJX0310(2/28/2026); 1194108D/00801741034510/REHZ1633(5/31/2025), REJN3882(5/31/2025), REJN3972(6/30/2025), REJP4057(7/31/2025), REJP4060(7/31/2025), REJP4066(7/31/2025), REJP4068(7/31/2025), REJR2209(9/30/2025), REJR2227(9/30/2025), REJS1269(9/30/2025), REJS2211(9/30/2025), REJS3526(10/31/2025), REJU1142(10/31/2025), REJV3948(1/31/2026); CK000757/00801741141133/REHZ1652(5/31/2025), REJQ0793(6/30/2025), REJR1443(8/31/2025), REJS1253(7/31/2025), REJS3543(8/31/2025), REJV0288(10/31/2025); CK001042/00801741224324/REHZ1657(5/31/2025), REJN2389(6/30/2025), REJR1448(9/30/2025), REJT0890(11/30/2025); 9174108/00801741035548/REJN0035(6/30/2025), REJQ0431(8/31/2025), REJR0582(9/30/2025); 1174108D1/00801741154737/REJN0722(5/31/2025), REJP1731(7/31/2025), REJR0469(8/31/2025), REJR2556(9/30/2025), REJS2083(10/31/2025); CK000631B/00801741143748/REJN0748(5/31/2025), REJP2723(7/31/2025), REJP2747(7/31/2025), REJS1310(9/30/2025), REJS4709(10/31/2025); 3194155/00801741027765/REJN0964(6/30/2025), REJN1080(6/30/2025), REJN4126(6/30/2025), REJQ0418(8/31/2025), REJS3757(10/31/2025), REJT1225(11/30/2025); 3174108/00801741027574/REJN1098(6/30/2025), REJR2206(9/30/2025), REJS2212(10/31/2025); CK000567/00801741108167/REJN1450(5/31/2025), REJQ0400(8/31/2025); 1194108D4/00801741155093/REJN2245(5/31/2025), REJP1828(7/31/2025), REJQ1321(6/30/2025), REJR0440(6/30/2025), REJR2590(7/31/2025), REJS2165(7/31/2025), REJS4634(7/31/2025); 1174108D2/00801741154836/REJN2302(5/31/2025), REJP1701(5/31/2025), REJQ1440(8/31/2025), REJR1289(9/30/2025), REJR2589(9/30/2025), REJS2453(10/31/2025), REJS4511(9/30/2025), REJU1046(11/30/2025); CK000677/00801741131790/REJN2329(5/31/2025), REJR1433(9/30/2025), REJS3919(10/31/2025); CK000864/00801741163302/REJN2340(5/31/2025), REJR1423(7/31/2025), REJR2685(7/31/2025), REJS2226(6/30/2025); CK000937A/00801741224003/REJN2347(5/31/2025), REJQ0824(6/30/2025), REJR2631(7/31/2025), REJS3571(8/31/2025); CK000930/00801741188091/REJN2351(5/31/2025), REJR2649(9/30/2025); CK001027/00801741223921/REJN2359(5/31/2025), REJR2690(9/30/2025), REJT1434(9/30/2025); 1174108D/00801741034459/REJN2362(5/31/2025), REJN2363(5/31/2025), REJP4065(7/31/2025), REJQ0816(8/31/2025), REJR0595(9/30/2025), REJR0600(9/30/2025), REJR2677(9/30/2025), REJS1284(9/30/2025), REJS2210(10/31/2025), REJS3915(10/31/2025), REJS4729(10/31/2025); CK000867/00801741163272/REJN2377(5/31/2025); CK000900/00801741184956/REJN2381(5/31/2025), REJR0589(6/30/2025), REJR1461(6/30/2025), REJS1259(6/30/2025), REJS2603(6/30/2025); CK000315A/00801741182723/REJN2391(6/30/2025), REJN3978(5/31/2025), REJQ2835(8/31/2025), REJR2697(9/30/2025), REJT1407(11/30/2025); CK000589A/00801741137624/REJN2395(6/30/2025), REJR2198(7/31/2025); CK000854B/00801741225802/REJN2400(6/30/2025), REJN3856(6/30/2025), REJQ2816(8/31/2025), REJS1317(9/30/2025), REJT0876(11/30/2025); CK000897/00801741184925/REJN2404(6/30/2025), REJN3860(6/30/2025), REJQ2807(6/30/2025), REJR2686(7/31/2025), REJS0277(7/31/2025), REJS1295(6/30/2025), REJT0874(7/31/2025); CK000953A/00801741223303/REJN2409(6/30/2025), REJS2228(8/31/2025), REJV1726(1/31/2026); CK000586B/00801741212789/REJN2420(6/30/2025), REJR1455(6/30/2025), REJR2211(7/31/2025); CK000549/00801741107313/REJN2427(6/30/2025), REJU2672(12/31/2025); CK000844/00801741154690/REJN3737(5/31/2025), REJS0060(9/30/2025); 1194108D1/00801741154782/REJN3778(5/31/2025), REJQ1238(8/31/2025), REJR2004(8/31/2025), REJS1173(7/31/2025); 1174108D4/00801741155048/REJN3820(5/31/2025), REJP1880(7/31/2025), REJR0536(6/30/2025), REJR1407(8/31/2025), REJR2563(6/30/2025), REJS2541(8/31/2025), REJS3729(7/31/2025); 1194108D3/00801741154997/REJN3821(5/31/2025), REJP3949(5/31/2025), REJR0537(9/30/2025), REJR2557(7/31/2025), REJS2084(10/31/2025), REJS4512(10/31/2025), REJU0239(11/30/2025); CK000934/00801741188381/REJN3864(6/30/2025), REJQ1483(8/31/2025), REJS4722(10/31/2025); CK000986/00801741216008/REJN3867(6/30/2025), REJN3923(5/31/2025), REJQ0825(7/31/2025), REJQ1499(7/31/2025), REJR2670(9/30/2025), REJS1324(10/31/2025), REJS4724(10/31/2025); CK000411/00801741096303/REJN3872(5/31/2025); CK001018/00801741222993/REJN3880(6/30/2025), REJQ1526(8/31/2025), REJT1397(9/30/2025); 1174108/00801741034442/REJN3881(5/31/2025), REJQ0432(8/31/2025), REJR2638(9/30/2025); CK000060/00801741028731/REJN3891(6/30/2025), REJQ0799(8/31/2025), REJQ1517(8/31/2025), REJR1432(9/30/2025), REJS1329(10/31/2025), REJS3916(10/31/2025); CK000513A/00801741110030/REJN3898(5/31/2025), REJS3539(8/31/2025); CK001021/00801741222863/REJN3927(6/30/2025) CK001030/00801741223976/REJN3970(6/30/2025), REJS0262(8/31/2025); CK000501A/00801741140815/REJN3980(6/30/2025), REJR2220(9/30/2025), REJT1408(11/30/2025), REJU2651(12/31/2025); CK000619A/00801741132001/REJN3985(6/30/2025); CK000903/00801741183089/REJN3999(6/30/2025), REJS0283(9/30/2025), REJT0909(11/30/2025); 3194108/00801741027710/REJN4166(6/30/2025), REJS3535(10/31/2025); 1194108D2/00801741154881/REJP0630(7/31/2025), REJR0470(8/31/2025), REJR0502(9/30/2025), REJS2556(10/31/2025); 9194108D/00801741035609/REJP1767(7/31/2025), REJR2695(9/30/2025); CK000959/00801741200960/REJP1942(7/31/2025), REJQ1524(8/31/2025), REJS0284(9/30/2025); CK000613/00801741121395/REJP1943(7/31/2025), REJQ1493(8/31/2025), REJR1670(9/30/2025), REJS0293(9/30/2025), REJS2216(10/31/2025), REJS4779(10/31/2025), REJV1721(1/31/2026); CK000991/00801741213298/REJP1950(5/31/2025), REJQ1512(8/31/2025), REJT1415(9/30/2025); CK000983/00801741225734/REJP2027(7/31/2025), REJP4183(7/31/2025), REJS1105(10/31/2025), REJS3409(10/31/2025); CK000881/00801741188787/REJP2717(7/31/2025), REJR1424(8/31/2025); CK000721/00801741137655/REJP2725(7/31/2025), REJR2213(9/30/2025), REJS1291(9/30/2025), REJT1365(11/30/2025); CK000642/00801741127908/REJP2727(7/31/2025), REJT0895(10/31/2025); CK000289C/00801741161148/REJP2728(7/31/2025), REJQ0813(8/31/2025), REJR2219(9/30/2025), REJS2203(9/30/2025), REJT1406(11/30/2025), REJV0222(9/30/2025), REJV1719(9/30/2025), REJX3527(1/31/2026); CK000894A/00801741188732/REJP2737(5/31/2025), REJS2218(10/31/2025); CK000914/00801741202599/REJP2741(7/31/2025), REJR1425(8/31/2025), REJS1319(9/30/2025), REJT0899(11/30/2025); CK000445/00801741101557/REJP2744(7/31/2025), REJR2662(9/30/2025); CK000687/00801741136535/REJP2746(6/30/2025), REJV3817(9/30/2025); CK000524A/00801741124068/REJP2748(6/30/2025), REJR1418(7/31/2025); CK000819/00801741152566/REJP2750(6/30/2025), REJS0294(6/30/2025); CK000266A/00801741185014/REJP2755(7/31/2025); 1174108D3/00801741154935/REJP4030(7/31/2025), REJR1272(9/30/2025), REJS1196(10/31/2025), REJS4633(7/31/2025); 3194108D/00801741027727/REJP4058(7/31/2025), REJS1304(5/31/2025); CK000545/00801741107399/REJP4222(1/31/2027), REJQ2267(2/28/2027); 1174108D5/00801741155147/REJQ0781(5/31/2025), REJQ1423(6/30/2025), REJS2164(6/30/2025), REJT0678(7/31/2025); 3174108D/00801741027581/REJQ0800(8/31/2025), REJQ1341(8/31/2025), REJR2656(9/30/2025); CK000775A/00801741188060/REJQ0807(8/31/2025), REJR1435(9/30/2025), REJS4754(10/31/2025), REJT0896(9/30/2025); 1194108D5/00801741155192/REJQ1441(6/30/2025), REJR1268(8/31/2025), REJS2058(7/31/2025), REJS3889(7/31/2025), REJT0862(7/31/2025); CK000736/00801741139499/REJQ1480(6/30/2025); CK000739/00801741139659/REJQ1601(6/30/2025), REJR2683(6/30/2025), REJS3894(8/31/2025), REJU1681(8/31/2025), REJV0873(8/31/2025), REJV3827(1/31/2026); 9194108/00801741028595/REJR0580(9/30/2025); 1194108/)00801741034503/REJR0596(9/30/2025), REJR2204(9/30/2025), REJS3533(10/31/2025); CK000660/00801741129650/REJR1419(9/30/2025), REJS1312(9/30/2025); CK000609A/00801741222504/REJR1654(6/30/2025); 9174108D/00801741035555/REJR1668(9/30/2025), REJR2230(9/30/2025); CK001067/00801741228711/REJR2202(8/31/2025), REJS3899(10/31/2025); CK000077D/00801741139598/REJR2231(9/30/2025); CK000882/00801741188794/REJS0259(8/31/2025), REJT0908(11/30/2025); CK000874/00801741178696/REJS0282(7/31/2025), REJS2188(6/30/2025), REJT1411(11/30/2025); CK000994/00801741215698/REJS0285(7/31/2025), REJS3572(8/31/2025); CK000870A/00801741184246/REJS3569(10/31/2025); CK000443C/00801741226557/REJT0880(10/31/2025); CK000668B/00801741228674/REJT1820(10/31/2025); CK000784/00801741189012/REJU0379(9/30/2025)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bard Access Systems, Inc.
Reason for Recall:
Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784

Product Codes/Lot Numbers:

REF/UDI-DI/Lot(Expiration): 3174155/00801741027611/REGQ0844(6/30/2025), REGZ1439(11/30/2025), REHP0860(11/30/2025), REHQ3097(6/30/2026), REHR0022(6/30/2026), REHT1151(7/31/2026), REHU1525(11/30/2026), REHU2455(6/30/2026), REHU2614(11/30/2026), REHV2765 (7/31/2026), REJN3472(2/28/2027), REJP4216(5/31/2027), REJQ2272(7/31/2027), REJR1411(8/31/2027), REJR2565(4/30/2027), REJR2614(8/31/2027), REJT0755(9/30/2027); CK000540/00801741105142/REGZ1425(10/31/2025), REHP0808(11/30/2025), REHU1513(1/31/2026), REHV2221(1/31/2026), REHY2842(10/31/2026), REJN4145 (12/31/2026), REJR1322(3/31/2027), REJS2110(4/30/2027), REJS3773(2/28/2027); 3174118/00801741027598/REGZ2512(11/30/2025), REHP1760(1/31/2026), REHP2603(1/31/2026), REJN1059(12/31/2026); CK000483/00801741099397/REHN3187(10/31/2025), REHQ1804(6/30/2026), REJN1065(5/31/2027), REJP2018(6/30/2027), REJR1321(8/31/2027); 3174335/00801741027628/REHN3908(10/31/2025), REHP0800(10/31/2025), REHQ3070(11/30/2025), REHT1129(5/31/2026), REHU1519(6/30/2026), REHV1391(7/31/2026), REHV3050(7/31/2026), REHZ1011(11/30/2026), REJN4109(12/31/2026), REJQ0405(2/28/2027), REJR2090(3/31/2027), REJT0833(5/31/2027); 3174355/00801741027635/REHQ1781(11/30/2025), REHS1925(4/30/2026), REHT1120(5/31/2026), REHU0975(6/30/2026), REHU2488(6/30/2026), REHV1400(7/31/2026), REHV3020(7/31/2026), REHW1329(8/31/2026), REHY1684(10/31/2026), REHZ1903(11/30/2026), REJN3007(12/31/2026), REJP0855(1/31/2027), REJP2021(1/31/2027), REJQ2284(2/28/2027), REJR2157(3/31/2027), REJS2171(4/30/2027), REJS4490(4/30/2027); CK000196/00801741028847/REHQ3064(6/30/2026), REHT2954(1/31/2026), REHX2926(12/31/2026), REHZ1873(3/31/2027), REJQ2279(8/31/2027); 9174118/00801741035562/REHQ3091(6/30/2026), REHR0017(6/30/2026), REHT1132(6/30/2026), REHU2496(6/30/2026), REHY2811(2/28/2026), REHZ1882(3/31/2027); CK000955/00801741200922/REHQ4029(11/30/2025), REHV2232(2/28/2026), REHX2916(12/31/2025), REHY3954(7/31/2026), REJN2995(9/30/2025); 3174135/00801741027604/REHR0003(11/30/2025), REHS4184(7/31/2026), REHU2356(11/30/2026), REHU2612(6/30/2026), REJS2089(9/30/2027); CK000617/00801741122286/REHS1001(9/30/2025), REJQ2280(2/28/2027); CK000839/00801741154393/REHS4241(4/30/2026), REHV3026(7/31/2026), REHX2908(9/30/2026), REHY2826(10/31/2026), REJN3000(12/31/2026), REJS3479(4/30/2027); 3194355/00801741027789/REHT2157(5/31/2025), REHT2967(5/31/2025), REHU3317(6/30/2025), REHV3031(7/31/2025), REHY3957(10/31/2025), REHZ1878(11/30/2025), REJN3008(12/31/2025), REJR1276(12/31/2025), REJR2062(3/31/2026), REJS2065(12/31/2025); 6174118/00801741139017/REHT2984(1/31/2026); 3194135/00801741027758/REHU1029(5/31/2025), REHY1636(10/31/2025), REHY2820(10/31/2025), REJN2980(12/31/2025); 3194335/00801741027772/REHU1430(6/30/2025), REHU2339(6/30/2025), REHW1354(8/31/2025), REHY2700(10/31/2025), REHZ1026(10/31/2025), REJN1463(12/31/2025), REJN3016(12/31/2025), REJR2013(3/31/2026), REJS3853(12/31/2025); 2174108/00801741138966/REHU3327(9/30/2025); 9194118/00801741028618/REHV0263(6/30/2025), REJQ0411(1/31/2026); 3194118/00801741027741REHY1654(10/31/2025), REJP0843(5/31/2025), REJS0206(3/31/2026); 1174118/00801741034466/REHY2815(5/31/2025), REJN1443(8/31/2025), REJQ0415(5/31/2025), REJQ2243(8/31/2025), REJS4488(10/31/2025); CK000285C/00801741161117/REHZ1477(5/31/2025), REJN2365(5/31/2025), REJQ2812(8/31/2025), REJR2208(9/30/2025), REJS1287(9/30/2025), REJS4740(10/31/2025); CK000335A/00801741101281/REHZ1620(5/31/2025), REJN2425(6/30/2025), REJQ0819(8/31/2025), REJQ1491(8/31/2025); CK000796/00801741144783/REHZ1625(5/31/2025), REJQ1521(8/31/2025), REJR1458(9/30/2025), REJS0258(9/30/2025), REJS3583(10/31/2025), REJT0877(11/30/2025), REJX0310(2/28/2026); 1194108D/00801741034510/REHZ1633(5/31/2025), REJN3882(5/31/2025), REJN3972(6/30/2025), REJP4057(7/31/2025), REJP4060(7/31/2025), REJP4066(7/31/2025), REJP4068(7/31/2025), REJR2209(9/30/2025), REJR2227(9/30/2025), REJS1269(9/30/2025), REJS2211(9/30/2025), REJS3526(10/31/2025), REJU1142(10/31/2025), REJV3948(1/31/2026); CK000757/00801741141133/REHZ1652(5/31/2025), REJQ0793(6/30/2025), REJR1443(8/31/2025), REJS1253(7/31/2025), REJS3543(8/31/2025), REJV0288(10/31/2025); CK001042/00801741224324/REHZ1657(5/31/2025), REJN2389(6/30/2025), REJR1448(9/30/2025), REJT0890(11/30/2025); 9174108/00801741035548/REJN0035(6/30/2025), REJQ0431(8/31/2025), REJR0582(9/30/2025); 1174108D1/00801741154737/REJN0722(5/31/2025), REJP1731(7/31/2025), REJR0469(8/31/2025), REJR2556(9/30/2025), REJS2083(10/31/2025); CK000631B/00801741143748/REJN0748(5/31/2025), REJP2723(7/31/2025), REJP2747(7/31/2025), REJS1310(9/30/2025), REJS4709(10/31/2025); 3194155/00801741027765/REJN0964(6/30/2025), REJN1080(6/30/2025), REJN4126(6/30/2025), REJQ0418(8/31/2025), REJS3757(10/31/2025), REJT1225(11/30/2025); 3174108/00801741027574/REJN1098(6/30/2025), REJR2206(9/30/2025), REJS2212(10/31/2025); CK000567/00801741108167/REJN1450(5/31/2025), REJQ0400(8/31/2025); 1194108D4/00801741155093/REJN2245(5/31/2025), REJP1828(7/31/2025), REJQ1321(6/30/2025), REJR0440(6/30/2025), REJR2590(7/31/2025), REJS2165(7/31/2025), REJS4634(7/31/2025); 1174108D2/00801741154836/REJN2302(5/31/2025), REJP1701(5/31/2025), REJQ1440(8/31/2025), REJR1289(9/30/2025), REJR2589(9/30/2025), REJS2453(10/31/2025), REJS4511(9/30/2025), REJU1046(11/30/2025); CK000677/00801741131790/REJN2329(5/31/2025), REJR1433(9/30/2025), REJS3919(10/31/2025); CK000864/00801741163302/REJN2340(5/31/2025), REJR1423(7/31/2025), REJR2685(7/31/2025), REJS2226(6/30/2025); CK000937A/00801741224003/REJN2347(5/31/2025), REJQ0824(6/30/2025), REJR2631(7/31/2025), REJS3571(8/31/2025); CK000930/00801741188091/REJN2351(5/31/2025), REJR2649(9/30/2025); CK001027/00801741223921/REJN2359(5/31/2025), REJR2690(9/30/2025), REJT1434(9/30/2025); 1174108D/00801741034459/REJN2362(5/31/2025), REJN2363(5/31/2025), REJP4065(7/31/2025), REJQ0816(8/31/2025), REJR0595(9/30/2025), REJR0600(9/30/2025), REJR2677(9/30/2025), REJS1284(9/30/2025), REJS2210(10/31/2025), REJS3915(10/31/2025), REJS4729(10/31/2025); CK000867/00801741163272/REJN2377(5/31/2025); CK000900/00801741184956/REJN2381(5/31/2025), REJR0589(6/30/2025), REJR1461(6/30/2025), REJS1259(6/30/2025), REJS2603(6/30/2025); CK000315A/00801741182723/REJN2391(6/30/2025), REJN3978(5/31/2025), REJQ2835(8/31/2025), REJR2697(9/30/2025), REJT1407(11/30/2025); CK000589A/00801741137624/REJN2395(6/30/2025), REJR2198(7/31/2025); CK000854B/00801741225802/REJN2400(6/30/2025), REJN3856(6/30/2025), REJQ2816(8/31/2025), REJS1317(9/30/2025), REJT0876(11/30/2025); CK000897/00801741184925/REJN2404(6/30/2025), REJN3860(6/30/2025), REJQ2807(6/30/2025), REJR2686(7/31/2025), REJS0277(7/31/2025), REJS1295(6/30/2025), REJT0874(7/31/2025); CK000953A/00801741223303/REJN2409(6/30/2025), REJS2228(8/31/2025), REJV1726(1/31/2026); CK000586B/00801741212789/REJN2420(6/30/2025), REJR1455(6/30/2025), REJR2211(7/31/2025); CK000549/00801741107313/REJN2427(6/30/2025), REJU2672(12/31/2025); CK000844/00801741154690/REJN3737(5/31/2025), REJS0060(9/30/2025); 1194108D1/00801741154782/REJN3778(5/31/2025), REJQ1238(8/31/2025), REJR2004(8/31/2025), REJS1173(7/31/2025); 1174108D4/00801741155048/REJN3820(5/31/2025), REJP1880(7/31/2025), REJR0536(6/30/2025), REJR1407(8/31/2025), REJR2563(6/30/2025), REJS2541(8/31/2025), REJS3729(7/31/2025); 1194108D3/00801741154997/REJN3821(5/31/2025), REJP3949(5/31/2025), REJR0537(9/30/2025), REJR2557(7/31/2025), REJS2084(10/31/2025), REJS4512(10/31/2025), REJU0239(11/30/2025); CK000934/00801741188381/REJN3864(6/30/2025), REJQ1483(8/31/2025), REJS4722(10/31/2025); CK000986/00801741216008/REJN3867(6/30/2025), REJN3923(5/31/2025), REJQ0825(7/31/2025), REJQ1499(7/31/2025), REJR2670(9/30/2025), REJS1324(10/31/2025), REJS4724(10/31/2025); CK000411/00801741096303/REJN3872(5/31/2025); CK001018/00801741222993/REJN3880(6/30/2025), REJQ1526(8/31/2025), REJT1397(9/30/2025); 1174108/00801741034442/REJN3881(5/31/2025), REJQ0432(8/31/2025), REJR2638(9/30/2025); CK000060/00801741028731/REJN3891(6/30/2025), REJQ0799(8/31/2025), REJQ1517(8/31/2025), REJR1432(9/30/2025), REJS1329(10/31/2025), REJS3916(10/31/2025); CK000513A/00801741110030/REJN3898(5/31/2025), REJS3539(8/31/2025); CK001021/00801741222863/REJN3927(6/30/2025) CK001030/00801741223976/REJN3970(6/30/2025), REJS0262(8/31/2025); CK000501A/00801741140815/REJN3980(6/30/2025), REJR2220(9/30/2025), REJT1408(11/30/2025), REJU2651(12/31/2025); CK000619A/00801741132001/REJN3985(6/30/2025); CK000903/00801741183089/REJN3999(6/30/2025), REJS0283(9/30/2025), REJT0909(11/30/2025); 3194108/00801741027710/REJN4166(6/30/2025), REJS3535(10/31/2025); 1194108D2/00801741154881/REJP0630(7/31/2025), REJR0470(8/31/2025), REJR0502(9/30/2025), REJS2556(10/31/2025); 9194108D/00801741035609/REJP1767(7/31/2025), REJR2695(9/30/2025); CK000959/00801741200960/REJP1942(7/31/2025), REJQ1524(8/31/2025), REJS0284(9/30/2025); CK000613/00801741121395/REJP1943(7/31/2025), REJQ1493(8/31/2025), REJR1670(9/30/2025), REJS0293(9/30/2025), REJS2216(10/31/2025), REJS4779(10/31/2025), REJV1721(1/31/2026); CK000991/00801741213298/REJP1950(5/31/2025), REJQ1512(8/31/2025), REJT1415(9/30/2025); CK000983/00801741225734/REJP2027(7/31/2025), REJP4183(7/31/2025), REJS1105(10/31/2025), REJS3409(10/31/2025); CK000881/00801741188787/REJP2717(7/31/2025), REJR1424(8/31/2025); CK000721/00801741137655/REJP2725(7/31/2025), REJR2213(9/30/2025), REJS1291(9/30/2025), REJT1365(11/30/2025); CK000642/00801741127908/REJP2727(7/31/2025), REJT0895(10/31/2025); CK000289C/00801741161148/REJP2728(7/31/2025), REJQ0813(8/31/2025), REJR2219(9/30/2025), REJS2203(9/30/2025), REJT1406(11/30/2025), REJV0222(9/30/2025), REJV1719(9/30/2025), REJX3527(1/31/2026); CK000894A/00801741188732/REJP2737(5/31/2025), REJS2218(10/31/2025); CK000914/00801741202599/REJP2741(7/31/2025), REJR1425(8/31/2025), REJS1319(9/30/2025), REJT0899(11/30/2025); CK000445/00801741101557/REJP2744(7/31/2025), REJR2662(9/30/2025); CK000687/00801741136535/REJP2746(6/30/2025), REJV3817(9/30/2025); CK000524A/00801741124068/REJP2748(6/30/2025), REJR1418(7/31/2025); CK000819/00801741152566/REJP2750(6/30/2025), REJS0294(6/30/2025); CK000266A/00801741185014/REJP2755(7/31/2025); 1174108D3/00801741154935/REJP4030(7/31/2025), REJR1272(9/30/2025), REJS1196(10/31/2025), REJS4633(7/31/2025); 3194108D/00801741027727/REJP4058(7/31/2025), REJS1304(5/31/2025); CK000545/00801741107399/REJP4222(1/31/2027), REJQ2267(2/28/2027); 1174108D5/00801741155147/REJQ0781(5/31/2025), REJQ1423(6/30/2025), REJS2164(6/30/2025), REJT0678(7/31/2025); 3174108D/00801741027581/REJQ0800(8/31/2025), REJQ1341(8/31/2025), REJR2656(9/30/2025); CK000775A/00801741188060/REJQ0807(8/31/2025), REJR1435(9/30/2025), REJS4754(10/31/2025), REJT0896(9/30/2025); 1194108D5/00801741155192/REJQ1441(6/30/2025), REJR1268(8/31/2025), REJS2058(7/31/2025), REJS3889(7/31/2025), REJT0862(7/31/2025); CK000736/00801741139499/REJQ1480(6/30/2025); CK000739/00801741139659/REJQ1601(6/30/2025), REJR2683(6/30/2025), REJS3894(8/31/2025), REJU1681(8/31/2025), REJV0873(8/31/2025), REJV3827(1/31/2026); 9194108/00801741028595/REJR0580(9/30/2025); 1194108/)00801741034503/REJR0596(9/30/2025), REJR2204(9/30/2025), REJS3533(10/31/2025); CK000660/00801741129650/REJR1419(9/30/2025), REJS1312(9/30/2025); CK000609A/00801741222504/REJR1654(6/30/2025); 9174108D/00801741035555/REJR1668(9/30/2025), REJR2230(9/30/2025); CK001067/00801741228711/REJR2202(8/31/2025), REJS3899(10/31/2025); CK000077D/00801741139598/REJR2231(9/30/2025); CK000882/00801741188794/REJS0259(8/31/2025), REJT0908(11/30/2025); CK000874/00801741178696/REJS0282(7/31/2025), REJS2188(6/30/2025), REJT1411(11/30/2025); CK000994/00801741215698/REJS0285(7/31/2025), REJS3572(8/31/2025); CK000870A/00801741184246/REJS3569(10/31/2025); CK000443C/00801741226557/REJT0880(10/31/2025); CK000668B/00801741228674/REJT1820(10/31/2025); CK000784/00801741189012/REJU0379(9/30/2025)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1507-2025

Related Recalls

Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga, D015251NK/ BD Needle Kit for Powered Driver 25mm x 15Ga, D015251MK/ BD Manual Driver Needle Kit 25mm x 15Ga, D015351NK/ BD Needle Kit for Powered Driver 35mm x 15Ga, D015351MK/ BD Manual Driver Needle Kit 35mm x 15Ga, D015451NK/ BD Needle Kit for Powered Driver 45mm x 15Ga, D015451MK/ BD Manual Driver Needle Kit 45mm x 15Ga, D015551NK/ BD Needle Kit for Powered Driver 55mm x 15Ga, D015551MK/ BD Manual Driver Needle Kit 55mm x 15G, D001001/ BD Intraosseous Powered Driver (drill)

Bard Access Systems

Class I - Dangerous

BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

Jun 20, 2022 Surgical Instruments Nationwide View Details →