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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 14, 2020 | Discovery NM670 Pro Model # H3100XB | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | Discovery NM 630 Model # H3101RH | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | NM/CT 850 Model Number: H3907AD | Rotor bearing screws were found loose on detector. | Class II | GE Healthcare, LLC |
| Aug 14, 2020 | Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the de... | This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 13, 2020 | Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Mem... | Possible false negative or false positive results. The incorrect sample collection swabs (non-sc... | Class II | Clinical Innovations, LLC |
| Aug 13, 2020 | Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 1030... | The firm registered the product as a Class I device, but has since been informed by FDA that the ... | Class II | Pharmaceutical Innovations, Inc. |
| Aug 13, 2020 | SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven ... | Due to non-surgical isolation gowns not meeting all performance test requirements. | Class II | Sobel Westex |
| Aug 13, 2020 | Critical Care Decontamination System (CCDS) Compatible N95 respirators - Pr... | Masks processed at one site were not maintained at levels of condensation during a portion of the... | Class II | Battelle Memorial Institute |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm,... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 -... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Stryker IsoAir 2.0 support surface-provides pressure redistribution and is in... | Connector between support surface and pump may be out of tolerance resulting in difficulty in rem... | Class II | Stryker Medical Division of Stryker Corporation |
| Aug 12, 2020 | Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Univer... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item... | The device staples may not properly form upon application preventing adequate hemostasis. Use of... | Class II | Covidien, LP |
| Aug 12, 2020 | Central Line Dressing Change Tray | Potential of incomplete seals impacting the sterility of the kit. | Class II | Medline Industries Inc |
| Aug 11, 2020 | Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated ... | May contain excess glue within the handle of the delivery system, resulting in an inability to fu... | Class II | Cook Inc. |
| Aug 11, 2020 | Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage... | An update to the carryover avoidance technical bulletin to introduce additional steps for reagent... | Class II | Randox Laboratories Ltd. |
| Aug 11, 2020 | Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: devic... | An update to the carryover avoidance technical bulletin to introduce additional steps for reagent... | Class II | Randox Laboratories Ltd. |
| Aug 10, 2020 | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a l... | Class II | Exactech, Inc. |
| Aug 7, 2020 | WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M... | Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Bil... | Class II | Boston Scientific Corporation |
| Aug 7, 2020 | FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-... | Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ... | Class II | Inpeco S.A. |
| Aug 7, 2020 | RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00... | Product may be mislabeled with the size etched onto products differing from the size information ... | Class II | Encore Medical, LP |
| Aug 7, 2020 | RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 | Product may be mislabeled with the size etched onto products differing from the size information ... | Class II | Encore Medical, LP |
| Aug 7, 2020 | Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter ... | Potential sterility issue | Class II | TELEFLEX MEDICAL INC |
| Aug 7, 2020 | Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual r... | Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ... | Class II | Inpeco S.A. |
| Aug 7, 2020 | Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual r... | Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has ... | Class II | Inpeco S.A. |
| Aug 7, 2020 | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG P... | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, ... | Class II | Tosoh Bioscience Inc |
| Aug 7, 2020 | Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: In... | Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This d... | Class III | Maquet Cardiovascular Us Sales, Llc |
| Aug 7, 2020 | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Dia... | Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, ... | Class II | Tosoh Bioscience Inc |
| Aug 6, 2020 | Merge PACS | Measurements done on the Merge PACS generated MPR s may have incorrect measurements. | Class II | Merge Healthcare, Inc. |
| Aug 6, 2020 | Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device ... | Due to the incorrect DC/DC converter being assembled onto the communication board. As a result t... | Class II | Carl Zeiss Meditec AG |
| Aug 6, 2020 | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... | COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... | Class II | Life Technologies Corporation |
| Aug 6, 2020 | PC Application Software c4D as part of the device Catalyst: SP-002 Software P... | PC Application Software c4D not changing Site upon synchronization during the Setup workflow step | Class II | C-RAD POSITIONING AB |
| Aug 6, 2020 | Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirco... | The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shr... | Class II | Talladium Inc |
| Aug 6, 2020 | Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnosti... | Due to the incorrect DC/DC converter being assembled onto the communication board. As a result t... | Class II | Carl Zeiss Meditec AG |
| Aug 6, 2020 | The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... | COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... | Class II | Life Technologies Corporation |
| Aug 5, 2020 | Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 0697157683101... | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Displ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 5, 2020 | Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 0697157683103... | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Displ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 5, 2020 | Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 0697157683104... | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Displ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 5, 2020 | Positron Emission Tomography and Computed Tomography System, Model uMI 550, R... | A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Displ... | Class II | Shanghai United Imaging Healthcare Co., Ltd. |
| Aug 4, 2020 | Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 | Tube trays may leak which could invalidate patient results or assay worklists, causing delayed re... | Class II | Hologic, Inc |
| Aug 4, 2020 | PC Unit Front Case with Keypad Replacement Kits: TC10008389 ASSY CASE FRONT ... | The pump module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingre... | Class I | CareFusion 303, Inc. |
| Aug 4, 2020 | BD Alaris System; Alaris Syringe Module Model 8110; BD Alaris System; Alari... | The Alaris PC unit can display incorrect syringe type and/or syringe sizes. This could result in... | Class I | CareFusion 303, Inc. |
| Aug 4, 2020 | BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, ... | Infusion pump component defect may result in interruption of patient monitoring | Class II | CareFusion 303, Inc. |
| Aug 4, 2020 | Integra Padgett Electric Dermatome Set - Product Usage: are intended for use ... | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... | Class II | Integra LifeSciences Corp. |
| Aug 4, 2020 | 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 a... | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts... | Class II | Integra LifeSciences Corp. |
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.