Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,276 FDA device recalls in 2022.

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DateProductReasonClassFirm
May 25, 2022 STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revit... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b.... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) ME... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULT... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNT... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Pref... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent Gen... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethyle... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catal... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class II Mckesson Medical-Surgical Inc. Corporate Office
May 24, 2022 Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 ... There is a risk that blind screws of the modular tibial component cannot be loosened intraoperati... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 24, 2022 Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos... There is a risk that blind screws of the modular tibial component cannot be loosened intraoperati... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 24, 2022 Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Int... It may occur that after system startup no stand movement is possible any longer in the event of a... Class II Siemens Medical Solutions USA, Inc
May 24, 2022 t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... Class II Tandem Diabetes Care Inc
May 24, 2022 Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (M... There is a risk that blind screws of the modular tibial component cannot be loosened intraoperati... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 24, 2022 BD Pyxis MedBank Cabinet Software v2.1.2.9 Legacy MedBank Cabinets with ... The automated dispensing cabinet software update included a .dll file that is not compatible with... Class II CareFusion 303, Inc.
May 24, 2022 t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insu... Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate ... Class II Tandem Diabetes Care Inc
May 24, 2022 Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2... There is a risk that blind screws of the modular tibial component cannot be loosened intraoperati... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
May 23, 2022 MiniMed 630G Insulin Pump (U.S. and Canada Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 620G Insulin Pump (O.U.S. version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 770G Insulin Pump (U.S. and O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 780G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 670G Insulin Pump (U.S. and O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 640G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 720G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 MiniMed 740G Insulin Pump (O.U.S. Version) Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (s... Class II Medtronic MiniMed
May 23, 2022 CustMbite, Model Number CBT-SRS-UL The device was marketed and sold in the US without FDA clearance. Class II Dental Choice Holding Llc
May 20, 2022 PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, ... Potential for stent dislodgement and associated failures related to two specific sizes of the dev... Class II Cordis US Corp
May 20, 2022 EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indica... Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... Class II DePuy Spine, Inc.
May 20, 2022 EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indica... Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... Class II DePuy Spine, Inc.
May 20, 2022 CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enume... High number of total images/unassigned events including (dual positives) and the potential for fa... Class II Menarini Silicon Biosystems
May 20, 2022 Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2... Label provided for substrate vail contained incorrect expiration date. Class III Agilent Technologies, Inc.
May 20, 2022 Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509... The firm has initiated this recall to replace component on devices distributed containing a compo... Class II Draeger Medical Systems, Inc.
May 20, 2022 regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. A nonsterile component was packaged in a sterile convenience kit. Class II ROi CPS LLC
May 20, 2022 Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 During system tests, an increased wearing of the Image acquisition system fans has been observed.... Class II Siemens Medical Solutions USA, Inc
May 19, 2022 MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th... Class II Chromsystems Instruments & Chemicals GmbH
May 19, 2022 Sensica Urine Output System Complaints relating to urine output measurement accuracy. Class II C.R. Bard Inc
May 19, 2022 MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of th... Class II Chromsystems Instruments & Chemicals GmbH
May 18, 2022 Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-28... Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. Class II Paragon 28, Inc.
May 18, 2022 ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 There is a potential for sporadic incidents of positive and negative biases for analyzer systems ... Class II Radiometer Medical ApS
May 18, 2022 MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metall... The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instruction... Class II DePuy Orthopaedics, Inc.
May 18, 2022 Dimension CTNI-In vitro diagnostic test intended to quantitively measure card... Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below... Class II Siemens Healthcare Diagnostics, Inc.
May 18, 2022 Dimension LTNI -In vitro diagnostic test intended to quantitively measure car... Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below... Class II Siemens Healthcare Diagnostics, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.