Browse Device Recalls

35,307 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,307 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 35,307 FDA device recalls, Class II.

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DateProductReasonClassFirm
Sep 1, 2023 Sub Q Recorder Pack, REF BPRC87A During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, Inc.
Aug 31, 2023 smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, ... The firm conducting a recall due to a complaint received indicating that a package contained a LE... Class II Smith & Nephew Inc
Aug 31, 2023 EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidest... A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... Class II Philips North America Llc
Aug 31, 2023 Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP Endobronchial implant devices may have been labeled with a shortened expiration date but they can... Class II Pulmonx, Corp.
Aug 31, 2023 EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream e... A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (... Class II Philips North America Llc
Aug 31, 2023 HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80... Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... Class II Access Vascular, Inc
Aug 31, 2023 HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the I... Class II Access Vascular, Inc
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 API3200MD Mass Spectrometer, Part Number 4466230 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-Z-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 300900000000, Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 Citrine QTRAP Mass Spectrometer, Part Number 5063685 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-L-200 Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Genera... Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance c... Class II RoyalVibe Health Ltd.
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-L-100. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 Citrine Triple Quad Mass Spectrometer, Part Number 5063684 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 29, 2023 Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quan... Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual ki... Class II CooperSurgical, Inc.
Aug 29, 2023 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... Unintended movement of bed wheels Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 29, 2023 Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to re... Device is breaking while in use, potential for patients to require a revision surgery. Class II Flower Orthopedics Corporation
Aug 29, 2023 REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 ... There is the potential that the safety shield may not properly engage on IV catheters. The needle... Class II Becton Dickinson Infusion Therapy Systems Inc.
Aug 29, 2023 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... Unintended movement of bed wheels Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 29, 2023 PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product... Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue,... Class II Limacorporate S.p.A
Aug 25, 2023 Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807 One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. Class II Beaver Visitec International, Inc.
Aug 25, 2023 Multichem P, Part Code 08P90-10 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Detector H. Pylori, Catalog Number IHP-30 Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the ... Class II Immunostics, Inc.
Aug 24, 2023 Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-... Full screen error message may occur on patient monitors with affected hardware version, either du... Class II Remote Diagnostic Technologies Ltd.
Aug 24, 2023 Various Medical Products stored on pallets, including but not limited to band... Various medical devices potentially exposed to rodent and rodent activity. In addition, medical d... Class II Inmar Supply Chain Solutions, LLC
Aug 24, 2023 AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 Peripheral coil system detachable has a potential of unsealed pouch packaging. Class II MICROVENTION INC.
Aug 23, 2023 MINISCAV (tm) Vacuum Pump Inadequate documentation of acceptance activity Class II R A Medical Services
Aug 23, 2023 LFS Flat screen support arm systems without surgical lamp for models Aurora s... The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... Class II DKK Dai-Ichi Shomei Co., Ltd.
Aug 23, 2023 Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 Expired Product distributed Class II Stryker Corporation
Aug 23, 2023 LFS Flat screen arm system with surgical lamp for Models Aurora series, Auror... The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... Class II DKK Dai-Ichi Shomei Co., Ltd.
Aug 22, 2023 Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implan... Class II Covidien LP
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designe... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qu... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 Puritan Bennett Cuff Pressure Manager, REF: 180-03 Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes t... Class II Covidien
Aug 22, 2023 therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Roto... Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_... Class II Qiagen GmbH
Aug 22, 2023 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualif... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 Apellis Injection Kit 29g Injection Needle -single use intended to inject flu... 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred charact... Class II Apellis Pharmaceuticals, Inc.

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.