Browse Device Recalls

1,023 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,023 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 1,023 FDA device recalls — Class III.

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DateProductReasonClassFirm
Oct 24, 2023 Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111 Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report ... Class III Fresenius Medical Care Holdings, Inc.
Sep 25, 2023 Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. Channel air drying process was not validated, and that a small percentage of scopes returned to c... Class III Aizu Olympus Co., Ltd.
Aug 14, 2023 KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides ... Class III Microbiologics Inc
Jul 25, 2023 ZVU Functional GI Software, REF: ZVU-3 GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0. Class III Diversatek Healthcare
May 18, 2023 VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di... May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). Class III Ortho-Clinical Diagnostics, Inc.
May 15, 2023 NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS... Potential for lot number discrepancies between the test strip packaging and the barcode label app... Class III NeuMoDx Molecular Inc
May 4, 2023 Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed qua... Delay in reporting results due to Quality Controls running high outside of range. Target value an... Class III Randox Laboratories Ltd.
May 4, 2023 Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality contr... Delay in reporting results due to Quality Controls running high outside of range. Target value a... Class III Randox Laboratories Ltd.
May 4, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080... The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 inc... Class III Datascope Corp.
Apr 24, 2023 Alinity i Anti-TPO Reagent Kit, List Number 09P3521 Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower ... Class III Abbott Ireland Limited
Apr 17, 2023 Total Knee Pack, REF CETJ130, medical convenience kits Incorrect expiration date on product. Class III American Contract Systems, Inc.
Apr 14, 2023 RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vit... QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labell... Class III Mechatronics USA
Apr 14, 2023 RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagn... QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labell... Class III Mechatronics USA
Mar 31, 2023 To be used with ultrasound endoscopes for ultrasound guided fine needle aspir... Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... Class III Olympus Corporation of the Americas
Mar 31, 2023 ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endo... Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifi... Class III Olympus Corporation of the Americas
Feb 17, 2023 Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 Distributed sample collection kit with an unapproved instruction for use. Class III AGILENT TECHNOLOGIES INC./US
Feb 1, 2023 PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials... Product is labeled with an incorrect expiration date. Class III Preat Corp
Jan 20, 2023 Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Mo... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Mo... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart R... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate M... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart R... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 5, 2023 abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF B... Incorrect expiration date on product label. The manufacturing date was listed as the expiration ... Class III S & MOHR AMERICA, S.A. DE C.V.
Jan 3, 2023 FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloop... Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, bu... Class III Owens & Minor Distribution, Inc.
Dec 5, 2022 Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 mislabeled product Class III Young Dental Manufacturing I, LLC
Nov 24, 2022 Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHI... Reaction vessels may contain a potential contaminant that could affect their optical performance. Class III Abbott Laboratories
Nov 7, 2022 Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prosth... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Nov 7, 2022 R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, ... For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration... Class III R & D Systems, Inc.
Nov 7, 2022 Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Sep 23, 2022 LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L0160... Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers wer... Class III LumiraDx
Sep 2, 2022 Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code C... Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barc... Class III Baxter Healthcare Corporation
Aug 19, 2022 MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001 Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible b... Class III Canadian Hospital Specialties
Aug 16, 2022 PTS Panels CHOL+GLU Test Strips (REF 1765) Incorrect instructions for use were packaged into the final product. Class III Polymer Technology Systems, Inc. dba PTS Diagno...
Aug 10, 2022 Verify SixCess Challenge Pack. Used to confirm that critical parameters of s... Product contains incorrect chemical indicators in packaging. Class III Steris Corporation Hopkins Facility
Jul 27, 2022 Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B... Product not registered for use in the UK Class III Microbiologics Inc
Jul 19, 2022 NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software vers... Due to an incorrect security key, customers were unable to connect to remote monitoring during sp... Class III NuVasive Inc
Jul 12, 2022 AXIOM Sensis or Sensis Vibe Combo systems as follows: System ... The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the ... Class III Siemens Medical Solutions USA, Inc
Jun 28, 2022 BIOPHEN UFH Control Plasma Incorrect product labeling was included in the package. Class III Aniara Diagnostica LLC
Jun 24, 2022 ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5... Class III Zeiss, Carl Inc
Jun 14, 2022 Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative co... The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm co... Class III R & D Systems, Inc.
Jun 10, 2022 Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Ca... Between March 2, 2021 and December 31, 2021, the product label used in production did not contain... Class III Invacare Corporation
Jun 9, 2022 Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF... A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... Class III Randox Laboratories Ltd.
Jun 9, 2022 Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use On... A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an... Class III Randox Laboratories Ltd.
May 31, 2022 NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # ... Firm has revised labeling to consistently call out storage conditions and revised the instruction... Class III Synapse Biomedical Inc
May 31, 2022 GreenLight HPSEA Laser Fibers, UPN 0010-2092 Several complaints were received for the affected lot; users received a "Fiber type does not matc... Class III Boston Scientific Corporation
May 25, 2022 a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560. Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. DYNAREX WeCare PETROLATUM JELLY, WHT 5GM (144/BX 6BX/CS) DYNREX Catalog #1... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office
May 25, 2022 a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. ... Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to highe... Class III Mckesson Medical-Surgical Inc. Corporate Office

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.