🔍 RecallPedia

All Recalls

95,114 total recalls in our database

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28,983
Food
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17,685
Drugs
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38,779
Medical Devices
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9,667
Consumer Products

MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

MICROVENTION

🏥 Medical Devices Class I - Dangerous

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

Dec 11, 2024 Implants & Prosthetics View Details →

(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00

CareFusion 303

🏥 Medical Devices Class I - Dangerous

Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

Jan 8, 2025 Other Medical Devices Nationwide View Details →

Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580

HF Acquisition Co

🏥 Medical Devices Class I - Dangerous

Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

Dec 11, 2024 Diagnostic Equipment Nationwide View Details →

Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U 6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X 7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y 8) SLH AAA PACK, Catalog Number:SCV13AASLA 9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10 10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4 11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5 12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6 13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7 14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8 15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9 16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP 17) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHQ 18) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHR 19) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHS 20) NEURO EMBOLISM PACK, Catalog Number:SNE11AN102 21) NEURO EMBOLISM PACK, Catalog Number:SNE11AN10E

Cardinal Health 200

🏥 Medical Devices Class I - Dangerous

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Nov 8, 2024 Other Medical Devices Nationwide View Details →

Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.

Getinge Usa Sales

🏥 Medical Devices Class I - Dangerous

Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.

Jan 15, 2025 Other Medical Devices View Details →

Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10¿ LNR G1 32MM 148-36-52 NV EHXL 10¿ LNR G2 36MM 148-36-53 NV EHXL 10¿ LNR G3 36MM 148-36-54 NV EHXL 10¿ LNR G4 36MM 148-36-55 NV EHXL 10¿ LNR G5 36MM 148-40-53 NV EHXL 10¿ LNR G3 40MM 148-40-54 NV EHXL 10¿ LNR G4 40MM 148-40-55 NV EHXL 10¿ LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.

Exactech

🏥 Medical Devices Class I - Dangerous

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

Dec 31, 2024 Implants & Prosthetics Nationwide View Details →

Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF108 6) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF109 7) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10V 8) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10W 9) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Y 10) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Z 11) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF111 12) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF112 13) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCP2 14) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP3 15) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP4 16) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPA 17) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPB 18) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPC 19) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPD 20) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPE 21) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPF

Cardinal Health 200

🏥 Medical Devices Class I - Dangerous

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Nov 8, 2024 Other Medical Devices Nationwide View Details →

The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

Ithera Medical Gmbh

🏥 Medical Devices Class I - Dangerous

The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).

Jan 8, 2025 Diagnostic Equipment Nationwide View Details →

Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUD 40) KIT, LAMINECTOMY, Catalog Number:PN41LMMYA 41) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA1 42) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA2 43) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA3 44) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA4 45) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU2 46) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU3 47) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU4 48) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU5 49) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU6 50) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU7 51) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAUJ 52) KIT, SPINE, Catalog Number:PNCGKSPI1 53) KIT, ACDF, Catalog Number:PNMVASNL1 54) KIT, ACDF, Catalog Number:PNMVASNL2 55) KIT, ACDF, Catalog Number:PNMVASNLA 56) KIT, ACDF, Catalog Number:PNMVASNLB 57) KIT, ACDF, Catalog Number:PNMVASNLC 58) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL2 59) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL3 60) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLA 61) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLB 62) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLC 63) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLD 64) KIT, SPINE FUSION, Catalog Number:PNMVSF454 65) KIT, SPINE FUSION, Catalog Number:PNMVSF45A 66) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA1 67) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA2 68) KIT,CRANIOTOMY, Catalog Number:PNOCCRZAA 69) KIT,LAMINECTOMY, Catalog Number:PNOCLAZA1 70) KIT,LAMINECTOMY, Catalog Number:PNOCLAZAA 71) KIT, LAMINECTOMY, Catalog Number:PNOCLAZAB 72) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH11 73) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH12 74) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH13 75) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH14 76) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH15 77) SPINE, HUNTINGTON, Catalog Number:PNOCSPHTU 78) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTV 79) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTW 80) KIT, ORTHO C

Cardinal Health 200

🏥 Medical Devices Class I - Dangerous

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Nov 8, 2024 Implants & Prosthetics Nationwide View Details →

(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338

CareFusion 303

🏥 Medical Devices Class I - Dangerous

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

Jan 8, 2025 Other Medical Devices Nationwide View Details →