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
Feb 1, 2024 Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, R... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Jan 19, 2024 TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-bas... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-base... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-base... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Jan 19, 2024 TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based... Customers unable to use cartridges due to formatting error in expiration date which leads to swit... Class III STRATASYS LTD
Dec 29, 2023 Achieva 3.0T, Model No. 781177 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 SmartPath to dStream for 1.5T, Model No. 781260, 782112 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Ingenia Ambition X, Model No. 782109 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Achieva 1.5T, Model No. 781178, 781196, 781296 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Intera 1.5T, Model No. 781195 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Dec 29, 2023 Achieva 1.5T Conversion, Model No. 781283 An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... Class III Philips North America
Nov 14, 2023 CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide ... CARDIOHELP-i System was not properly tested to measure leakage current Class III Maquet Medical Systems USA
Nov 7, 2023 Navik 3D v2, REF NAVIK3D, 3D Mapping System IFU update Class III APN Health LLC
Nov 6, 2023 SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assa... A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when ... Class III Randox Laboratories Ltd.
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 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
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
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 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 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 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 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 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 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.
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.
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...

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.