Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 18, 2020 | MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP3... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item N... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProS... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-214... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-10... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number ... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 14, 2020 | Dual Mobility Vivacit-E Bearing, Model Number 110031009 | The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size... | Class II | Zimmer Biomet, Inc. |
| 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 | 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 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 |
| Jul 30, 2020 | Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Numb... | Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa ... | Class II | Cook Inc. |
| Jul 24, 2020 | Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barrica... | The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner co... | Class II | Intrinsic Therapeutics, Inc. |
| Jul 21, 2020 | Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: markete... | Disposable face masks labeled as non-medical were distributed to customers expecting medical use ... | Class II | BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA |
| Jul 20, 2020 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic ... | Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0... | Class II | Conformis, Inc. |
| Jul 20, 2020 | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Us... | Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant me... | Class II | NOBEL BIOCARE SERVICES AG |
| Jul 17, 2020 | Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal p... | A low risk of a false positive result being issued with a laboratory developed test (LDT) that ut... | Class II | Cytocell Ltd. |
| Jul 17, 2020 | Parvovirus B19 IgG EIA kit Part No. V519IGUS | Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value | Class II | Diasorin Inc. |
| Jul 16, 2020 | Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usag... | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Oxford Immunotec |
| Jul 16, 2020 | Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usag... | Incorrect expiration date included in test kit labeling and/or in Substrate component label. | Class III | Oxford Immunotec |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, L... | US-dates between the product package label and the bar code display. | Class II | Hager & Meisinger Gmbh |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 15, 2020 | StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Produc... | The product contains a non-functional component not referenced in product labeling. | Class II | Stimwave Technologies Inc |
| Jul 14, 2020 | Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement ... | Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... | Class II | Olympus Corporation of the Americas |
| Jul 14, 2020 | Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement... | Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143... | Class II | Olympus Corporation of the Americas |
| Jun 24, 2020 | PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1... | Reagents were shipped to customers after the Use by data indicated on its labeling. | Class III | DNA Genotek Inc. |
| Jun 23, 2020 | Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electro... | The label on the cardbox and the blister show the correct symbols for sterilization using irradia... | Class II | Sutter Medizintechnik GmbH |
| Jun 18, 2020 | Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box | Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rub... | Class II | Mueller Sports Medicine, Inc |
| Jun 18, 2020 | MatrixNEURO Screws - Product Usage: The intended use for this device is in fi... | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm s... | Class II | Synthes, Inc. |
| Jun 15, 2020 | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell C... | Convenience kit mislabeled with the incorrect catheter effective length on the device label and t... | Class III | Access Scientific LLC |
| Jun 5, 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component mod... | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec... | Class II | OrthoPediatrics Corp |
| Jun 5, 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component mod... | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrec... | Class II | OrthoPediatrics Corp |
| Jun 3, 2020 | PrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3,... | The tubes may have been delivered to some users without labels. Users may not be able to identify... | Class II | LONGHORN VACCINES AND DIAGNOSTIC |
| Jun 3, 2020 | COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Len... | Mislabeled: Printing on the top web or Tyvek lid of the individual product blister tray indicati... | Class II | CooperSurgical, 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.