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
Nov 22, 2025 The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED ... Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 S. Typhi/Para Typhi A Antigen Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PA... Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Vivoo Protein Test Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Exploro Highly Sensitive Male Fertility / Sperm Concentration Test Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 22, 2025 Male Fertility Sperm Test for Home Use (Cassette) Test strips and other tests including for near-patient testing, that require a 510(k) were distri... Class II Changchun Wancheng Bio-Electron Co., Ltd.
Nov 17, 2025 Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1... A customer experienced that during assembly and load testing of the device, the bolt for mounting... Class II ETAC A/S
Nov 17, 2025 Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mob... A customer experienced that during assembly and load testing of the device, the bolt for mounting... Class II ETAC A/S
Nov 17, 2025 Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1)... A customer experienced that during assembly and load testing of the device, the bolt for mounting... Class II ETAC A/S
Nov 17, 2025 Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mob... A customer experienced that during assembly and load testing of the device, the bolt for mounting... Class II ETAC A/S
Nov 10, 2025 Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right,... The device has been delivered with a preassembled locking screw that had been inserted from the w... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-10; The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched... Class II Inpeco S.A.
Oct 30, 2025 FlexLab (FLX); Version: FLX-217-40; The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatche... Class II Inpeco S.A.
Oct 17, 2025 IntelePACS - InteleConnect / TechPortal Software application that receives digital images and data to be communicated, processed, manipul... Class II INTELERAD MEDICAL SYSTEMS INCORPORATED
Oct 14, 2025 BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarb... Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactat... Class II Beckman Coulter Ireland, Inc.
Oct 9, 2025 bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914;... The impacted lot may not meet the required tensile strength specification. Class I Glycar SA Pty., Ltd.
Oct 9, 2025 bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: ... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510... The impacted lot may not meet the required tensile strength specification. Class I Glycar SA Pty., Ltd.
Oct 9, 2025 UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imagin... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulse... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 9, 2025 Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; Sys... GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... Class II B-K Medical A/S
Oct 2, 2025 Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Numb... The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eve... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Oct 1, 2025 Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product De... Potential for contamination with cotton fibers. Class II ENDOMAGNETICS LTD
Oct 1, 2025 Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product D... Potential for contamination with cotton fibers. Class II ENDOMAGNETICS LTD
Sep 30, 2025 Material Processing Laser Products Lack of Remote Interlock Connector - required per 21 CFR 1040.10(f)(3) Class II SHENZHEN ATOMSTACK TECHNOLOGIES
Sep 26, 2025 Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model... Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening ... Class II Medistim Asa
Sep 16, 2025 Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9... Due to two distinct issues: 1. During patient admission, patient demographic fields may default ... Class II Spacelabs Healthcare, Ltd.
Sep 9, 2025 Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build ... Potential that the measured value may be smaller than the actual area. Class II MedicalCommunications GmbH
Sep 3, 2025 Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Ass... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associ... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Assoc... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K1... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: ... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K1... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; A... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K1306... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; A... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K1306... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K13084... Systems may not perform as intended due to the deterioration of certain internal components (the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K1020... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 3, 2025 Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K1... The BIOS battery may deplete faster than initially anticipated during the design phase. When the ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.