Browse Device Recalls

2,049 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,049 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 2,049 FDA device recalls in N/A.

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DateProductReasonClassFirm
Mar 29, 2024 Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, s... Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), ... Class II Stryker Leibinger GmbH & Co. KG
Mar 29, 2024 LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N... Due to unsupported 10 year expiration date. Class II CORENTEC CO., LTD
Mar 29, 2024 LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A ... Due to unsupported 10 year expiration date. Class II CORENTEC CO., LTD
Mar 25, 2024 RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic co... Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... Class II Ossur H / F
Mar 25, 2024 RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic... Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... Class II Ossur H / F
Mar 25, 2024 RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic... Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... Class II Ossur H / F
Mar 25, 2024 RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic co... Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... Class II Ossur H / F
Mar 18, 2024 GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Innova IGS 5, computed tomography x-ray system GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 18, 2024 GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems GE HealthCare has become aware of the potential that adhesive material might not have been applie... Class II GE Medical Systems, SCS
Mar 15, 2024 PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TL... Due to receiving information regarding difficulties with the insertion of a setscrew inside a scr... Class II SPINEART SA
Mar 13, 2024 Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Numbe... Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... Class II Electro Medical Systems SA
Mar 13, 2024 Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number:... Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... Class II Electro Medical Systems SA
Mar 13, 2024 Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: E... Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... Class II Electro Medical Systems SA
Mar 5, 2024 Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml ... Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351... Class II Randox Laboratories Ltd.
Mar 4, 2024 IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, an... There is a risk of mistreatment as irradiation is not prevented when some safety parameters are o... Class II Ion Beam Applications S.A.
Feb 23, 2024 RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A... A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si,... Class II RAYSEARCH LABORATORIES AB
Feb 23, 2024 Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg... Patient lift hanger bar may come loose, which could potentially pose risks to patients. Class II Human Care Hc Sweden Ab
Feb 14, 2024 HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P... Automated external defibrillators were shipped in their test configuration so there is a potentia... Class II HeartSine Technologies Ltd
Feb 14, 2024 Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of t... Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods Class II Randox Laboratories Ltd.
Feb 8, 2024 Software VERIQA (S070031), version 2.0 and 2.1- Software package for display,... Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold ... Class II PTW-FREIBURG
Feb 6, 2024 SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, ... Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Feb 6, 2024 SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 Azurion 3 with a Certeray generator -To perform image guidance in diagnostic,... Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Feb 6, 2024 SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, ... Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Feb 6, 2024 SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 2, 2024 CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS909... Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractur... Class I Medos International Sarl
Jan 29, 2024 Shimadzu, Trinias, Digital Angiography System Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnorm... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Jan 25, 2024 IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) ... Due to an error in the manufacturing process, it is possible that an incorrect plunger has been f... Class II Voco GmbH
Jan 25, 2024 Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, ... Due to an error in the manufacturing process, it is possible that an incorrect plunger has been f... Class II Voco GmbH
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 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 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 16, 2024 W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Mo... 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. Th... Class II W&H DENTALWERK BUERMOOS GMBH
Jan 2, 2024 Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 2, 2024 Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 2, 2024 Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 2, 2024 Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically t... Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jan 2, 2024 Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the D... Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Dec 26, 2023 GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lulla... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.
Dec 26, 2023 GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: ... GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, ... Class I Wipro GE Healthcare Private Ltd.

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.