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 |
|---|---|---|---|---|
| Apr 16, 2021 | ARIES HSV 1&2 Assay, Part Number/REF 50-10017 | Impacted lot may leak inside the ARIES instrument. | Class II | Luminex Corporation |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | The Sarns Temperature Control and Monitor unit (TCM) is a source of temperatu... | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Us... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | The Sarns TCM II (system) is a source of temperature-controlled water for blo... | Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns... | Class II | Terumo Cardiovascular Systems Corporation |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Us... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 16, 2021 | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. | Instruments were assembled and serviced using a defective lot of tubing, which is part of the pum... | Class II | Hardy Diagnostics |
| Apr 16, 2021 | Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product... | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V8... | Class II | Draeger Medical, Inc. |
| Apr 15, 2021 | Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay sy... | There is a potential for abnormal inflation of the mattress. | Class II | Getinge (Suzhou) Co Ltd |
| Apr 15, 2021 | Colpassist Vaginal Positioning Device - Product Usage: intended for use in ge... | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render t... | Class II | Boston Scientific Corporation |
| Apr 15, 2021 | Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicros... | Examination data and patient name may be mixed up when printing or generating a pdf with the inte... | Class II | Haag-Streit USA Inc |
| Apr 15, 2021 | UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usa... | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render th... | Class II | Boston Scientific Corporation |
| Apr 15, 2021 | T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) -... | Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending su... | Class II | Flower Orthopedics Corporation |
| Apr 15, 2021 | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit... | Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the t... | Class II | Vygon U.S.A. |
| Apr 14, 2021 | Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrec... | Barcode label extended expiration date. Barcode located at the short side of the outer box shows ... | Class II | Dutch Ophthalmic USA, Inc. |
| Apr 14, 2021 | Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for... | There is a potential leak between the venous patient connector and patient's hemodialysis access. | Class II | Baxter Healthcare Corporation |
| Apr 14, 2021 | Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is ... | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Radiometer Medical ApS |
| Apr 14, 2021 | Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also ... | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Radiometer Medical ApS |
| Apr 14, 2021 | E3800 PC Units (spare parts) | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Class II | Radiometer Medical ApS |
| Apr 14, 2021 | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, ... | specimens collected in transport media may result is false negative results when stored in certai... | Class II | Beckman Coulter Inc. |
| Apr 13, 2021 | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to pro... | Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury | Class II | Philips North America Llc |
| Apr 12, 2021 | DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 0... | failed rivet at the chafe tab of arm sling. | Class II | DJ Orthopedics de Mexico S.A. de C.V. |
| Apr 12, 2021 | DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)001904466735... | failed rivet at the chafe tab of arm sling. | Class II | DJ Orthopedics de Mexico S.A. de C.V. |
| Apr 12, 2021 | VICI RDS VENOUS STENT System Product Usage: is indicated for improving lum... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 12, 2021 | DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446... | failed rivet at the chafe tab of arm sling. | Class II | DJ Orthopedics de Mexico S.A. de C.V. |
| Apr 12, 2021 | VICI VENOUS STENT System Product Usage: is intended for the treatment of o... | The firm has received reports of stent migration after implantation | Class I | Boston Scientific Corporation |
| Apr 12, 2021 | DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00... | failed rivet at the chafe tab of arm sling. | Class II | DJ Orthopedics de Mexico S.A. de C.V. |
| Apr 9, 2021 | Kit: Blood Culture MAI Kit Part Number: 80076 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: Injection REVIEW MAI Kit Part Number: 74736 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | COVID-19 Self-Test Kit *** INNOVA *** 7T | Due to distributing test kits to customers who were not part of a clinical investigation. | Class I | INNOVA MEDICAL GROUP, INC. |
| Apr 9, 2021 | PERLA TL Lateral Connector Open - Product Usage: intended to be used with aut... | Due to external labelling error/mix-up. Affected product external labels list the incorrect rod ... | Class II | SPINEART SA |
| Apr 9, 2021 | Kit: Midline Insertion DA. MAI Kit Part Number: 77981B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part ... | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | Kit: Blood Culture. MAI Kit Part Number: 80315D | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAK... | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-... | Due to distributing test kits to customers who were not part of a clinical investigation. | Class I | INNOVA MEDICAL GROUP, INC. |
| Apr 9, 2021 | Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B | Medical convenience kits are being recalled due to a potential breach in the package integrity o... | Class I | Medical Action Industries, Inc. 306 |
| Apr 9, 2021 | COVID-19 Self-Test Kit *** INNOVA *** 3T | Due to distributing test kits to customers who were not part of a clinical investigation. | Class I | INNOVA MEDICAL GROUP, INC. |
| Apr 9, 2021 | DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03. | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 9, 2021 | FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020. | Medical convenience kits are being recalled due to a potential breach in the package integrity of... | Class I | Avid Medical, Inc. |
| Apr 8, 2021 | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2,... | The supplier informed them of possible deviations of the parameters/processes defined for ethylen... | Class II | Spes Medica |
| Apr 8, 2021 | Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR ... | Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld | Class II | Windstone Medical Packaging, Inc. |
| Apr 8, 2021 | Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalo... | Emergency Use Application (EUA) application withdrawn as false negative results reported | Class II | Meridian Bioscience Inc |
| Apr 8, 2021 | CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for int... | Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw | Class II | Smith & Nephew, Inc. |
| Apr 8, 2021 | SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating... | The supplier informed them of possible deviations of the parameters/processes defined for ethylen... | Class II | Spes Medica |
| Apr 8, 2021 | Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bo... | Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld | Class II | Windstone Medical Packaging, Inc. |
| Apr 8, 2021 | Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. ... | The supplier informed them of possible deviations of the parameters/processes defined for ethylen... | Class II | Spes Medica |
| Apr 8, 2021 | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 7.5-10.0, Channel 1... | The supplier informed them of possible deviations of the parameters/processes defined for ethylen... | Class II | Spes Medica |
| Apr 8, 2021 | Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Tra... | Emergency Use Application (EUA) application withdrawn as false negative results reported | Class II | Meridian Bioscience 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.