🔍 RecallPedia

All Recalls

95,018 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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9,571
Consumer Products

Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

Guangzhou Pluslife Biotech Co.

🏥 Medical Devices Class I - Dangerous

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Jan 24, 2025 Implants & Prosthetics Nationwide View Details →

Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.

Preat

🏥 Medical Devices Class I - Dangerous

Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.

Apr 2, 2025 Implants & Prosthetics Nationwide View Details →

ICU Medical Plum Solos, Item number 400011001; infusion pump

ICU Medical

🏥 Medical Devices Class I - Dangerous

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

Apr 22, 2025 Infusion Pumps Nationwide View Details →

Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342 PRES0206CXPPLT 00810068567359 PRES0208CXPPLT 00810068567366 PRES3520CXPPLT 00810068567441 PRES3530CXPPLT 00810068567458 PRES0310CXPPLT 00810068567403 PRES0320CXPPLT 00810068567410 PRES0420CPKPLT 00810068567489 PRES0517CPKPLT 00810068567519 PRES0540CPKPLT 00810068568028 PRES0620CPKPLT 00810068567557 PRES0635CPKPLT 00810068567564 PRES0650CPKPLT 00810068567571 PRES0720CPKPLT 00810068567588 PRES0735CPKPLT 00810068567595 PRES0750CPKPLT 00810068567601 PRES0830CPKPLT 00810068567618 PRES0845CPKPLT 00810068567625 PRES0153HXPPL 00818053027147 PRES0204HXPPL 00818053029943 PRES0204CXPPL 00818053027321 PRES0208HXPPL 00818053029981 PRES0315HXPPL 00818053027178 PRES0307CXPPL 00818053027376 PRES0420HPKPL 00818053027185 PRES0440HPKPL 00810068567830 PRES0520HPKPL 00818053027192 PRES0540HPKPL 00810068567847 PRES0650HPKPL 00810068567854 PRES0720HPKPL 00818053027215 PRES0750HPKPL 00810068567861 PRES0830HPKPL 00818053027222 The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.

BALT USA

🏥 Medical Devices Class I - Dangerous

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

May 8, 2025 Implants & Prosthetics Nationwide View Details →

UROSKOP Omnia. Model Number: 10094910

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

Jun 4, 2025 Other Medical Devices Nationwide View Details →

Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).

Cook Incorporated

🏥 Medical Devices Class I - Dangerous

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

May 15, 2025 Diagnostic Equipment View Details →

Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)

Dexcom

🏥 Medical Devices Class I - Dangerous

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

May 12, 2025 Infusion Pumps Nationwide View Details →

ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump

ICU Medical

🏥 Medical Devices Class I - Dangerous

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

Apr 22, 2025 Infusion Pumps Nationwide View Details →

5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.

Apr 29, 2025 Other Medical Devices Nationwide View Details →

Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3)

Dexcom

🏥 Medical Devices Class I - Dangerous

Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.

May 12, 2025 Infusion Pumps Nationwide View Details →

Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 00818053026461 OPTI1137COM18 00818053026478 OPTI1550COM18 00818053026515 OPTI0101CSS10 00818053025709 OPTI0101HSS10 00840303700951 OPTI0102CSS10 00818053025716 OPTI0102HSS10 00840303700968 OPTI0103HSS10 00818053026591 OPTI0103CSS10 00818053025723 OPTI0104HSS10 00818053026607 OPTI0254CSS10 00840303700548 OPTI0255CSF10 00840303700203 OPTI0256CSS10 00818053025853 OPTI0256HSS10 00818053026737 OPTI0202HSS10 00840303701040 OPTI0203HSS10 00840303701057 OPTI0203CSS10 00818053025785 OPTI0204CSS10 00840303700494 OPTI0204HSS10 00840303701064 OPTI0206CSF10 00818053026027 OPTI0206CSS10 00818053025808 OPTI0208CSF10 00818053026034 OPTI0208HSS10 00840303701088 OPTI0208CSS10 00840303700517 OPTI0358CSS10 00818053025921 OPTI0310HSS10 00840303701156 OPTI0310CSS10 00818053025907 OPTI0310HSF10 00840303700814 OPTI0310CSF10 00840303700234 OPTI0304HSS10 00840303701125 OPTI0304HSF10 00840303700784 OPTI0304CSS10 00818053025877 OPTI0306HSS10 00840303701132 OPTI0308HSS10 00840303701149 OPTI0308CSF10 00818053026065 OPTI0308CSS10 00840303700593 OPTI0410CSS10 00840303700654 OPTI0410HSF10 00840303700852 OPTI0413CSF10 00818053026119 OPTI0406HSS10 00840303701163 OPTI0408HSS10 00818053026799 OPTI0413CST10 00840303700036 OPTI0510HSS10 00840303701217 OPTI0510CSS10 00840303700685 OPTI0510HSF10 00840303700890 OPTI0513CSS10 00840303700692 OPTI0517CSF10 00818053026157 OPTI0517CST10 00840303700050 OPTI0508CSS10 00840303700678 OPTI0509CSF10 00818053026140 OPTI0610HSF10 00840303700937 OPTI0611CSF10 00818053026171 OPTI0620CSF10 00840303700357 OPTI0620HST10 00840303700715 OPTI0713CST10 00840303700081 OPTI0713CSF10 00840303700364 OPTI0724CSF10 00818053026218 OPTI0724CST10 00840303700098 OPTI0724COM18 00818053026430 OPTI0827CSF10 00818053026232 OPTI0827CST10 00840303700111 OPTI0923CST10 00818053026379 OPTI0930COM18 00818053026454 OPTI0153HSSMX 00818053025419 OPTI1040CSFMX 00818053025280 OPTI1245CSFMX 00818053025303 OPTI1445CSFMX 00818053025327 OPTI1650CSFMX 00818053025341 OPTI0103CSSMX 00840303701408 OPTI2525CSSMX 00840303701477 OPTI0255CSSMX 00818053025020 OPTI0202CSSMX 00818053024979 OPTI3535CSSMX 00818053025068 OPTI0310CSSMX 00818053025051 OPTI0307CSSMX 00818053025044 OPTI4510CSFMX 00818053025143 OPTI4545CSFMX 00818053025136 OPTI0413CSFMX 00818053025129 OPTI0404CSFMX 00818053025099 OPTI0407CSFMX 00818053025105 OPTI0510CSFMX 00818053025167 OPTI0507CSFMX 00818053025150 OPTI0715CSFMX 00818053025228 OPTI0720CSFMX 00818053025235 OPTI0930CSFMX 00818053025266 The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.

BALT USA

🏥 Medical Devices Class I - Dangerous

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

May 8, 2025 Implants & Prosthetics Nationwide View Details →

RTSALSA1LB 1# EAST COAST FRESH Salsa Cup - 1 lb ALL LOT CODES SAL20 5# EAST COAST FRESH EC-Salsa- Fresh 5# ALL LOT CODES SAL210 6/1# EAST COAST FRESH Salsa- Fresh Retail 6x1# (E) ALL LOT CODES SAL45 20# EAST COAST FRESH EC-Salsa- Fresh 20# ALL LOT CODES SAL48 7# EAST COAST FRESH EC-Salsa- Mild 7# (E) ALL LOT CODES RTSALSA1LB 1# EAST COAST FRESH Salsa Cup - 1 lb ALL LOT CODES SAL20 5# EAST COAST FRESH EC-Salsa- Fresh 5# ALL LOT CODES SAL21 6/1# EAST COAST FRESH EC-Salsa- Fresh Retail 6x1# ALL LOT CODES SAL210 6 / 1# EAST COAST FRESH SALSA RETAIL 1# CUP (6/CASE) ALL LOT CODES SAL45 20# EAST COAST FRESH EC-Salsa- Fresh 20# ALL LOT CODES SAL460 6 / 1# EAST COAST FRESH Salsa HOT 6/1# ALL LOT CODES SAL519 6/1# EAST COAST FRESH Salsa HOT 6/1lb TOPS (E) ALL LOT CODES SAL532 6/1# TOPS SALSA RETAIL 1lb CUP (6/CASE)- TOPS (E) ALL LOT CODES SAL540 6/30oz WELLSLEY FARMS Wellsley Farms Mild Salsa 6/30oz (E) ALL LOT CODES SALSA166WEIS 6/16 oz WEIS SALSA MILD 6/16oz WEIS ALL LOT CODES SALSABUCKET20 20# EAST COAST FRESH Salsa Fresh Bucket 20# ALL LOT CODES SALSAHOT1 1# EAST COAST FRESH Salsa Hot 1 lb ALL LOT CODES SALSAHOT61 6/1# EAST COAST FRESH Salsa HOT 6/1# ALL LOT CODES SALSAHOT61TOPS 6/1 # TOPS Salsa HOT 6/1# TOPS ALL LOT CODES SALSAHOTAHOLD 6/1 # AHOLD Salsa HOT 6/1# - AHOLD ALL LOT CODES SALSARET1 6/1# EAST COAST FRESH SALSA RETAIL 1# CUP (6/CASE) ALL LOT CODES SALSARET121 12/1# AHOLD Salsa Retail 12/1#- AHOLD ALL LOT CODES SALSARET1NL 6/1 # EAST COAST FRESH SALSA RETAIL 1# CUP (NL) (6/CASE) ALL LOT CODES SALSARET1TOPS 6/1# TOPS SALSA RETAIL 1# CUP (6/CASE)- TOPS ALL LOT CODES SALSATUB51 5# EAST COAST FRESH Salsa Fresh 5# ALL LOT CODES SALSAWELLFMD306 6/30 OZ WELLSLEY FARMS Wellsley Farms Mild Salsa 6/30oz ALL LOT CODES SAL519 6/1# EAST COAST FRESH Salsa HOT 6/1lb TOPS (E) ALL LOT CODES SAL532 6 / 1# TOPS SALSA RETAIL 1lb CUP (6/CASE)- TOPS (E) ALL LOT CODES SAL540 6/30oz WELLSLEY FARMS Wellsley Farms Mild Salsa 6/30oz (E) ALL LOT CODES SALSA166WEIS 6/16oz WEIS SALSA MILD 6/16oz WEIS ALL LOT CODES SALSABUCKET20 20# EAST COAST FRESH Salsa Fresh Bucket 20# ALL LOT CODES SALSAHOT1 1# EAST COAST FRESH Salsa Hot 1 lb ALL LOT CODES SALSAHOT61 6 / 1# EAST COAST FRESH Salsa HOT 6/1# ALL LOT CODES SALSAHOT61TOPS 6 / 1# TOPS Salsa HOT 6/1# TOPS ALL LOT CODES SALSAHOTAHOLD 6 / 1# AHOLD Salsa HOT 6/1# - AHOLD ALL LOT CODES SALSARET1 6 / 1# EAST COAST FRESH SALSA RETAIL 1# CUP (6/CASE) ALL LOT CODES SALSARET121 12 / 1# AHOLD Salsa Retail 12/1#- AHOLD ALL LOT CODES SALSARET1NL 6 / 1# EAST COAST FRESH SALSA RETAIL 1# CUP (NL) (6/CASE) ALL LOT CODES SALSARET1TOPS 6 / 1# TOPS SALSA RETAIL 1# CUP (6/CASE)- TOPS ALL LOT CODES SALSATUB51 5# EAST COAST FRESH Salsa Fresh 5# ALL LOT CODES SALSATUB71 7# EAST COAST FRESH Salsa Fresh Tub 7 lbs ALL LOT CODES SALSAWELLFMD306 6 /30 oz WELLSLEY FARMS Wellsley Farms Mild Salsa 6/30oz ALL LOT CODES

Sysco

🍎 Food Class I - Dangerous

Cucumbers have the potential to be contaminated with Salmonella

May 21, 2025 Other Foods View Details →