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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.