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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single u... RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was la... Class II Rayner Intraocular Lenses Limited
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Cat... Iincorrectly packaged without the required lidocaine as labeled Class II Becton Dickinson & Company
Mar 17, 2020 Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 A... Sterility compromised due to packaging pouches that may not be sealed properly Class II Bard Peripheral Vascular Inc
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY,... There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... Class II Applied Medical Resources Corp
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY... There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... Class II Applied Medical Resources Corp
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 17, 2020 Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902 Space between the device and the packaging permits excessive movement which could potentially lea... Class II Smith & Nephew, Inc.
Mar 17, 2020 Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... Class II Applied Medical Resources Corp
Mar 17, 2020 safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulti... Class II Radiometer Medical ApS
Mar 17, 2020 DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has ... Class II Applied Medical Resources Corp
Mar 17, 2020 Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD ... Inadequate incoming inspection practices were utilized on thermistor sensors used in the producti... Class II Degania Medical Devices Pvt. Ltd.
Mar 16, 2020 Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolate... Extended Expiration Date prior to clearance Class II Life Technologies Corporation
Mar 16, 2020 Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isol... Extended Expiration Date prior to clearance Class II Life Technologies Corporation
Mar 16, 2020 Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isola... Extended Expiration Date prior to clearance Class II Life Technologies Corporation
Mar 16, 2020 Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated... Extended Expiration Date prior to clearance Class II Life Technologies Corporation
Mar 16, 2020 CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causin... Class II Avanos Medical, Inc.
Mar 16, 2020 Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium ... The inner lumen of the Langston catheter may separate from the hub during pressure injection. Class I Vascular Solutions, Inc.
Mar 13, 2020 Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model ... There were unknown bioburden levels prior to sterilization, which may affect sterility of the pro... Class II Biomet, Inc.
Mar 13, 2020 SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: ... A high frequency output (2 MHz) has not been cleared for distribution in the U.S. Class II Aesthetics Biomedical, Inc.
Mar 12, 2020 Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 19... A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB devi... Class II Fresenius Medical Care Holdings, Inc.
Mar 12, 2020 Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T ... A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB devi... Class II Fresenius Medical Care Holdings, Inc.
Mar 12, 2020 VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot n... Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the... Class II Greiner Bio-One North America, Inc.
Mar 11, 2020 PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT During the sterilization of radial compression devices, some of the inflatable balloons may break... Class II Merit Medical Systems, Inc.
Mar 11, 2020 The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VI... There is a potential for the occurrence of false positive OXSF results for some Staphylococcus au... Class II Biomerieux Inc
Mar 11, 2020 Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISI... Updated Instructions For Use- to contraindications and potential complications/adverse events of ... Class II Boddingtons Plastics Ltd
Mar 10, 2020 smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pre... Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model ... Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model... Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Mode... Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, Americ... Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. Class II Northgate Technologies, Inc.
Mar 10, 2020 SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Us... Intermittent failure of a signal being sent to a monitor from the touch panel display causing the... Class II Skytron, Div. The KMW Group, Inc
Mar 10, 2020 AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usag... Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. Class II Northgate Technologies, Inc.
Mar 10, 2020 ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of wh... Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ... Class II Radiometer Medical ApS
Mar 10, 2020 smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. Class III Ortho Clinical Diagnostics
Mar 10, 2020 smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are... As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompat... Class II Northgate Technologies, Inc.
Mar 10, 2020 medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1... Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model... Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD Inc.
Mar 10, 2020 smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092 Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System ... Class II Smiths Medical ASD 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.