Browse Device Recalls

1,011 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,011 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 1,011 FDA device recalls — Class III.

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DateProductReasonClassFirm
Dec 3, 2024 The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is ... Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the inc... Class III Qualigen Inc
Oct 28, 2024 Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a de... Due to incorrect labels applied to devices during servicing. Labels contain the incorrect produc... Class III Remote Diagnostic Technologies Ltd.
Oct 15, 2024 a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340... Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes... Class III Alcon Research LLC
Oct 1, 2024 Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is i... Due to heart transmitter not being able to upgrade to the current software version in the field a... Class III Abbott Medical
Oct 1, 2024 Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merl... Due to heart transmitter not being able to upgrade to the current software version in the field a... Class III Abbott Medical
Sep 30, 2024 Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Numbe... For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been ... Class III Zyno Medical LLC
Sep 13, 2024 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitat... The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match th... Class III DRG International, Inc.
Sep 12, 2024 iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intende... Incorrect GTIN number. Class III Iotamotion Inc
Sep 3, 2024 Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a st... The patient label stickers may have the wrong expiration date recorded. The contract manufacturer... Class III Trackx Technology Inc
Aug 8, 2024 eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals ... Class III T.G. Eakin Limited
Jul 26, 2024 BiomarC EX Fiducial Marker System, Catalog Number 040165 This recall has been initiated due to a failure to provide an MRI Insert that is to be provided t... Class III Carbon Medical Technologies, Inc.
Jul 16, 2024 Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF... Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec C... Class III Beckman Coulter, Inc.
Jul 12, 2024 NavaClick Syringe and Needle, Model Number LIN02 Incorrect GTIN number on carton. Class III LINEAGE BIOMEDICAL, INC
Jul 5, 2024 Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Pr... Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would... Class III DRG International, Inc.
May 14, 2024 VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the V... Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration da... Class III Ortho-Clinical Diagnostics, Inc.
May 8, 2024 VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagno... The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 120... Class III Ortho-Clinical Diagnostics, Inc.
Apr 5, 2024 Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative ... Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that... Class III Randox Laboratories Ltd.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Feb 20, 2024 HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) Product was mislabeled as a Surgical Cap at its dispenser level. Class III O&M HALYARD, 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 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 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 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 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
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 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
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 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
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
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 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.
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.
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

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.