Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
Aug 30, 2021 OPTETRAK Comprehensive Knee System custom devices labeled as the following: ... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylen... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX).... Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Class II Exactech, Inc.
Aug 30, 2021 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 27, 2021 United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part,... Due to product not meeting specification for concentricity and failing to meet requirements of dy... Class II Uoc Usa Inc
Aug 27, 2021 Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft versi... When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or Ver... Class II PTW NORTH AMERICA CORPORATION
Aug 27, 2021 Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL;... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I North Coast Medical Inc
Aug 27, 2021 10 ga ARS Decompression Needle, Part Number ZZ-0298 The device includes the incorrect Instructions for Use. Class II North American Rescue LLC.
Aug 27, 2021 Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray ... Base plate may detach from the main body of the treatment applicator. Class II Xstrahl Limited
Aug 27, 2021 EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Descripti... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I North Coast Medical Inc
Aug 26, 2021 SIGNA Premier nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 Discovery MR750 3.0T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Artist nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Voyager nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 Discovery MR750w 3.0T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 Atrium Pneumostat Chest Drain Valve, Part Number 16100 The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after ... Class II Atrium Medical Corporation
Aug 26, 2021 SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Architect nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 Optima MR450w 1.5T nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 26, 2021 SIGNA Pioneer nuclear magnetic resonance imaging system Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D... Class II GE Healthcare, LLC
Aug 25, 2021 HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... Class II Instrumentation Laboratory
Aug 25, 2021 Operating room table - Product Usage: intended for use during diagnostic exam... ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... Class II Deerfield Imaging, Inc.
Aug 25, 2021 HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic ... Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... Class II Instrumentation Laboratory
Aug 25, 2021 HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative dete... Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrum... Class II Instrumentation Laboratory
Aug 25, 2021 Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Accelerated Care Plus Corporation
Aug 25, 2021 Operating room table - Product Usage: intended for use during diagnostic exam... ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... Class II Deerfield Imaging, Inc.
Aug 25, 2021 Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Produ... The product package may potentially contain a mismatched graft that does not contain the radial s... Class II Atrium Medical Corporation
Aug 25, 2021 Operating room table - Product Usage: intended for use during diagnostic exam... ORT200/300 rotational lock may fail to function such that it cannot change states between locked ... Class II Deerfield Imaging, Inc.
Aug 24, 2021 McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16... Potential for difficulty in safety mechanism activation. Class II Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021 McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16... Potential for difficulty in safety mechanism activation. Class II Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021 McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, M... Potential for difficulty in safety mechanism activation. Class II Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021 HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 10... Potential for difficulty in safety mechanism activation. Class II Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021 ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmissio... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I National Distribution & Contracting Inc
Aug 24, 2021 DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only Potential for a wire protrusion through the left heart vent catheter tip Class II Medtronic Perfusion Systems
Aug 24, 2021 Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/... Due to misbranded products shipped to customers. Class II Bard Peripheral Vascular Inc
Aug 24, 2021 McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, M... Potential for difficulty in safety mechanism activation. Class II Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021 Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiratio... Due to misbranded products shipped to customers. Class II Bard Peripheral Vascular Inc
Aug 24, 2021 HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 10... Potential for difficulty in safety mechanism activation. Class II Zhejiang Kindly Medical Devices Co., Ltd.
Aug 24, 2021 ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I National Distribution & Contracting Inc
Aug 24, 2021 DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only Potential for a wire protrusion through the left heart vent catheter tip Class II Medtronic Perfusion Systems
Aug 23, 2021 Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in ac... Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Aesthetics Systems Usa Inc
Aug 20, 2021 SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an ext... The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequ... Class II Microbiologics Inc
Aug 20, 2021 Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75... Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. Class II Greiner Bio-One North America, Inc.
Aug 20, 2021 LiquaSonic Ultrasound Gel 5L, Model No. 001222 Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Athena Medical Products Inc
Aug 20, 2021 LiquaSonic Ultrasound Gel 250mL, Model No. 001205 Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial co... Class I Athena Medical Products Inc
Aug 20, 2021 SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an e... The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically rele... Class II Microbiologics Inc
Aug 20, 2021 DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) Primary packaging labeling may be incorrect. Class II ConvaTec, Inc
Aug 19, 2021 P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 The rear heater plate and cover assembly that contains the electrical wiring for the heaters does... Class II Fort Defiance Industries, LLC

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.