Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Jun 14, 2024 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, R... 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 Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic R... 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 Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.... 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 Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear... 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 L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x ... Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains in... Class II Argon Medical Devices, Inc
Jun 14, 2024 SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX... 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 MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magne... 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 Infusion Pump System... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.... 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 Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury ... The tiller separates from the base/front caster assembly. If the knee walker fails, a user may f... Class II Medical Depot Inc.
Jun 14, 2024 SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Reson... 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 Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX... 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 Discovery MR750w 3.0T, 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 Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury ... The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fa... Class II Medical Depot Inc.
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wi... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1... 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 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 Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, 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 Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 Improperly performed testing prior to release Class II Baxter Healthcare Corporation
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Ca... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic... 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 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: 2-8-540HAN 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 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 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: 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 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 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 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 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 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 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 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.

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.