Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 18, 2020 | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) | Product may be mislabeled. | Class II | Merete Medical GmbH |
| Sep 17, 2020 | LOM Disposable Surgical Gowns/Medical Gowns, Single-Use | Medical gowns distributed to customers did not include appropriate labeling, and some gowns may n... | Class II | THREAD COUNSEL INC DBA LAWS OF MOTION |
| Sep 14, 2020 | Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the p... | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the pe... | Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to... | Class II | Becton Dickinson & Company |
| Sep 14, 2020 | MR Coils The MR Coil is intended to be used in conjunction with a Magnetic... | The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protect... | Class III | Invivo Corporation |
| Sep 9, 2020 | VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - ... | Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. T... | Class II | Ethicon, Inc. |
| Sep 8, 2020 | MediCult Vitrification Cooling Media, Model Number 12284001F | There is a discrepancy between the printing on the Product Tyvek label of the individual componen... | Class II | CooperSurgical, Inc. |
| Aug 31, 2020 | AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Nu... | Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. | Class II | Encore Medical, LP |
| Aug 28, 2020 | Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to... | Label has the incorrect size for the tracheotomy tube. | Class II | Smiths Medical ASD Inc. |
| Aug 26, 2020 | Pacific Xtreme (PTCA Balloon Dilation Catheter) | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | Class II | ev3 Inc. |
| Aug 24, 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICA... | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... | Class II | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Aug 24, 2020 | EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indic... | Multiple or incorrect expiration dates were provided on the affected designation labels. | Class II | Smith & Nephew, Inc. |
| Aug 24, 2020 | Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICA... | Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contain... | Class II | Irvine Biomedical Inc, a St. Jude Medical Co. |
| Aug 21, 2020 | 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged ... | Lack of sterility assurance of the 30-0171 | Class II | North American Rescue LLC. |
| Aug 18, 2020 | CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "A... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| Aug 18, 2020 | MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AM... | Various immunoassay enzymes failed product performance, thereby the products do not consistently ... | Class II | Ameditech Inc |
| 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 |
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.