Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Jun 14, 2024 SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Alinity hq Analyzer, REF: 09P68-01 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then ... Class II Abbott Laboratories
Jun 14, 2024 Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Discrete photometric chemistry analyzer for clinical use. Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoa... Class II Beckman Coulter, Inc.
Jun 14, 2024 SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnet... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 t... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 14, 2024 SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR3... GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can... Class II GE Medical Systems, LLC
Jun 13, 2024 Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizo... Non-conformance pertains to electromagnetic compatibility requirements according to the internati... Class II Hologic Inc
Jun 13, 2024 Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups ... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups prov... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jun 13, 2024 Braun Thermoscan¿ PRO 6000 Ear Thermometer The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) con... Class II Baxter Healthcare Corporation
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jun 13, 2024 Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups prov... IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ... Class II Steris Corporation
Jun 12, 2024 BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration ... Sterilization certificates could not be validated by the supplier Class I Synergetics Inc
Jun 12, 2024 BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the ad... Sterilization certificates could not be validated by the supplier Class I Synergetics Inc
Jun 12, 2024 BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administrati... Sterilization certificates could not be validated by the supplier Class I Synergetics Inc
Jun 12, 2024 Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M... Foreign material may be present on the enclosed section of the cutting wire which may lead to ina... Class II Boston Scientific Corporation
Jun 12, 2024 BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intra... Sterilization certificates could not be validated by the supplier Class I Synergetics Inc
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each ... The protective pouches were identified to have been improperly labeled with UDI that is associate... Class II Medical Action Industries, Inc. 306
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963 Some foil pouches were found torn open, impacting the sterile barrier which was traced to a speci... Class II Ethicon Sarl, a Johnson & Johnson Company
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961 Some foil pouches were found torn open, impacting the sterile barrier which was traced to a speci... Class II Ethicon Sarl, a Johnson & Johnson Company
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Numb... A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to no... Class II Canadian Hospital Specialties Ltd.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 11, 2024 Various Merit Medical convenience kits that contain recalled Jiangsu Shenli M... Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... Class II Merit Medical Systems, Inc.
Jun 10, 2024 BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing ... Class II BioFire Diagnostics, LLC
Jun 10, 2024 BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing ... Class II BioFire Diagnostics, LLC
Jun 7, 2024 AURORA Surgiscope System. Sterile, single use device that contains a Sheath, ... Potential sheath damage that could lead to tissue damage and/or track hemorrhage. Class II Integra LifeSciences Corp.

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.