Browse Device Recalls

2,115 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,115 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 2,115 FDA device recalls in N/A.

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DateProductReasonClassFirm
Apr 3, 2025 Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 8... The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Apr 3, 2025 Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulato... Potential for exoskeleton to lose lateral balance and cause patient to fall. Class II WANDERCRAFT SAS
Apr 3, 2025 Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm)... The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Apr 2, 2025 HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software ... There is a leakage issue associated with the tubing in the manifold of the instrument. Class II Leica Biosystems Melbourne Pty Ltd
Apr 2, 2025 Washer Disinfector Aquadis 56; Model Number: 56A The frequency inverter is not programmed by supplier according to specification which causes the ... Class II Getinge Disinfection Ab
Apr 2, 2025 Washer Disinfector Aquadis 56; Model Number: 56M The frequency inverter is not programmed by supplier according to specification which causes the ... Class II Getinge Disinfection Ab
Apr 1, 2025 myQA iON; Article Number: MQ10-000; Wrong analysis results can occur if the user creates two structures with the same name, except fo... Class II IBA Dosimetry GmbH
Mar 27, 2025 Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate... Class II IHB OPERATIONS B.V.
Mar 26, 2025 The Trimble RTS873 robotic total station is a solution designed for construct... An issue has been identified in the production of the RTS873 robotic total stations that may resu... Class II Trimble Ab
Mar 21, 2025 GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radio... ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 a... Class II Radiometer Medical ApS
Mar 21, 2025 GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 21, 2025 GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002 GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... Class I GE Medical Systems China Co., Ltd.
Mar 19, 2025 Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, P... Medical device software marketed without FDA clearance . Class II Spectrum Medical Ltd.
Mar 19, 2025 Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological... Medical device software marketed without FDA clearance . Class II Spectrum Medical Ltd.
Mar 14, 2025 Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 A potential weakness has been identified in the probe body, so that, in a specific production bat... Class II ESAOTE S.P.A.
Mar 14, 2025 DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002) Potential of compromised compatibility resulting in influence on the positioning of the reference... Class II Pro-Med Instruments Gmbh
Mar 12, 2025 Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter ... Due to manufacturing issues there is a potential for the catheter sheath to detach. Class I Conavi Medical Inc.
Mar 5, 2025 stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, pack... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Art... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE20... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Ste... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, pa... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 5, 2025 stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packa... Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... Class II Tornier S.A.S.
Mar 3, 2025 Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Ste... Five complaints received where surgeon was unable to remove and/or connect the inserter with the ... Class II ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Feb 19, 2025 Lazervida 10W diode laser cutter and engraver with Lazervida shield. Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in ... Class II Flux Technology Inc.
Feb 17, 2025 Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-M... Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RE... Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-M... Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Microstream Instructions for Use and Part Number used with - Product Descript... Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... Class II Oridion Medical 1987 Ltd.
Feb 17, 2025 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 All in One Bundle; Model Number: FG-BNDL-PC-REFAIO; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY LTD)
Feb 17, 2025 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900; Product lacks 510(k) clearance. Class II DAYE (ANNE'S DAY 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.