Browse Device Recalls

1,040 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,040 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 1,040 FDA device recalls, Class III.

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DateProductReasonClassFirm
Jan 6, 2022 BD Vacutainer Luer Lok Access Device - intended as a sterile, single use devi... May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cel... Class III Becton Dickinson & Company
Dec 17, 2021 Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI... One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. Class III LivaNova Deutschland GmbH
Dec 15, 2021 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Dec 15, 2021 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language b... Class III CellEra LLC
Nov 19, 2021 Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU T... The Instructions for Use provided with the device contained information intended for use of a mec... Class III Ki Mobility Llc
Nov 10, 2021 iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery S... The dosage information on the pouch is incorrect; the primary carton label is correct. Class III Tapemark Company
Oct 15, 2021 VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 ... Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-... Class III Ortho-Clinical Diagnostics, Inc.
Oct 14, 2021 SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 202... Class III Cardiac Assist, Inc
Oct 5, 2021 A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Con... The Control Level I material value was showing results exceeding the upper limit of the acceptabl... Class III Primus Corporation dba Trinity Biotech
Oct 5, 2021 Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-00... The Control Level I material value was showing results exceeding the upper limit of the acceptabl... Class III Primus Corporation dba Trinity Biotech
Jul 29, 2021 Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - P... Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instru... Class III Sentinel CH SpA
Jul 15, 2021 Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15,... Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expi... Class III Cell Marque Corporation
Jul 15, 2021 Pneupac paraPac plus 300 ventilator kit, REF P300NGB Two devices were labeled with the same serial number Class III Smiths Medical ASD Inc.
Jul 12, 2021 Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic rea... Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vi... Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 1, 2021 GlideScope Go Monitors Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into ... Class III Verathon, Inc.
May 27, 2021 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Tele... Telepack may not power on when using the 3AA battery cradle. Class III Mindray DS USA, Inc. dba Mindray North America
Apr 30, 2021 ACE Control Set - IVD Control set for the quantitative determination of Angio... Claim for stability after reconstitution from lyophilized to liquid form does not meet the requir... Class III Sentinel CH SpA
Apr 21, 2021 VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Apr 21, 2021 VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... Due to inadvertently shipping to U.S. customers with international labeling which has some differ... Class III MICROVENTION INC.
Mar 23, 2021 VenaSeal Closure System Firm received increased number of reports that VenaSeal dispensing systems are not effectively ad... Class III Medtronic Inc.
Mar 22, 2021 Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aor... There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... Class III Datascope Corp.
Mar 22, 2021 Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aor... There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that m... Class III Datascope Corp.
Mar 16, 2021 EXALT Controller - Product Usage: intended for use with a Boston Scientific e... May have been programmed with a less than optimal brightness setting resulting in a darker than ... Class III Boston Scientific Corporation
Feb 24, 2021 KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0... Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. Class III Microbiologics Inc
Feb 24, 2021 KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged... Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. Class III Microbiologics Inc
Feb 5, 2021 Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination ... Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labelin... Class III OraSure Technologies, Inc.
Jan 28, 2021 Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve ba... It was identified that tissue culture bags were incorrectly labeled as free of phthalates. Class III OriGen Biomedical, Inc.
Jan 15, 2021 S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended... Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O30300... Class III Medline Industries Inc
Jan 5, 2021 Nucleic acid-based in vitro diagnostic devices for the detection of 2019-nove... Users cannot complete testing due to a sign-error in the software component that controls the fil... Class III Biomeme, Inc.
Jan 5, 2021 HAMILTON-H900 Humidifier, Models: 950001, 950004 When starting a humidifier, intended for respiratory gas conditioning during invasive and noninva... Class III Hamilton Medical AG
Dec 22, 2020 Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-... FUJIFILM has become aware that incorrect concentration values were printed on the bottle label fo... Class III Fujifilm Medical Systems U.S.A., Inc.
Dec 16, 2020 KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affecte... The expiration date on the label of one component (negative control 0243U) in the set lot is inco... Class III Microbiologics Inc
Nov 10, 2020 AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102... The products subject to this recall may contain obvious, incorrect pouch labels while the outer b... Class III Applied Medical Technology Inc
Oct 16, 2020 VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use... Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verif... Class III Ortho Clinical Diagnostics Inc
Oct 9, 2020 Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling b... Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary c... Class III Talladium Inc
Oct 8, 2020 KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM) The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil... Class III Microbiologics Inc
Oct 7, 2020 Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid ... Potential for cleaning solution intrusion into endoscope Class III Steris Corporation
Oct 6, 2020 Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box... Class III Hardy Diagnostics
Sep 30, 2020 XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Steri... Cervical Implants contain a label that incorrectly identifies the grade of titanium used. Class III XTANT Medical
Sep 26, 2020 AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 us... Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... Class III Advanced Bionics, LLC
Sep 26, 2020 AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 us... Mislabeling; It has been determined that some batteries were improperly labeled and may contain a... Class III Advanced Bionics, LLC
Sep 21, 2020 SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products 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.