Browse Device Recalls

38,509 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38,509 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 38,509 FDA device recalls.

DateProductReasonClassFirm
Oct 13, 2025 MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE a... Due to battery component overheating while charging resulting in melting of internal components a... Class II MRIMed Inc.
Oct 13, 2025 Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of ... Class II Paragon 28, Inc.
Oct 10, 2025 Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMa... Acute circulatory support system pump may not fit into the motor and reports received of the pump... Class II Thoratec LLC
Oct 10, 2025 Anesthesia Circuit Kits and other various kits that contain Anesthesia Circui... Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINO... Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT D... Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 Convenience Kit, BREAST HERNIA DYNJ909125G Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 Anesthesia Circuit Kits and other various kits that contain Anesthesia Circui... Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GEN... Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 Anesthesia Circuit Kits and other various kits that contain Anesthesia Circui... Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 10, 2025 Anesthesia Circuit Kits and other various kits that contain Anesthesia Circui... Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandabl... Class I Medline Industries, LP
Oct 9, 2025 Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage t... The heat function may become damaged over time due to patients pressing on the areas with heat fu... Class II Pivotal Health Solutions, Inc.
Oct 9, 2025 Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Numbe... Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed fo... Class II C-RAD POSITIONING AB
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 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
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 Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table The heat function may become damaged over time due to patients pressing on the areas with heat fu... Class II Pivotal Health Solutions, Inc.
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Ca... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
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 Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) M... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
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 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Mod... Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... Class II Thoratec LLC
Oct 9, 2025 Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/... Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/appro... Class II Myofunctional Research Company USA
Oct 8, 2025 Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CAT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 8, 2025 Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WIT... Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... Class II Sterilmed, Inc.
Oct 8, 2025 REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, ... Automated cell-locating device barcode reader may read the barcode of the previously processed sl... Class II Cellavision AB
Oct 8, 2025 Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Tr... The device may either fail to start up, or the transducer may start briefly and then stop, accomp... Class II Olympus Corporation of the Americas
Oct 7, 2025 GM85 Digital Mobile X-ray imaging System; Model Number: GM85; The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture... Class II NeuroLogica Corporation
Oct 7, 2025 Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Ac... The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the poten... Class II Meridian Bioscience Inc
Oct 7, 2025 Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Mode... Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that ... Class II Trividia Health, Inc.
Oct 7, 2025 Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Ac... The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the poten... Class II Meridian Bioscience Inc
Oct 7, 2025 SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected ... Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which c... Class II Philips Respironics, Inc.
Oct 6, 2025 Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tub... The nasal feeding tube may be occluded Class II Applied Medical Technology Inc
Oct 6, 2025 Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma... Class I Tandem Diabetes Care, Inc.
Oct 6, 2025 Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Si... Sterility compromised from small holes that may occur during packaging of the device pouches into... Class II Olympus Corporation of the Americas
Oct 6, 2025 Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... Class II Abbott Medical
Oct 6, 2025 IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038... The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... Class II Siemens Healthcare Diagnostics, Inc.
Oct 6, 2025 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE ... The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... Class II Siemens Healthcare Diagnostics, Inc.
Oct 6, 2025 Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tub... The nasal feeding tube may be occluded Class II Applied Medical Technology Inc
Oct 6, 2025 Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Produ... Sterility compromised from small holes that may occur during packaging of the device pouches into... Class II Olympus Corporation of the Americas
Oct 6, 2025 Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tub... The nasal feeding tube may be occluded Class II Applied Medical Technology Inc
Oct 6, 2025 Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tub... The nasal feeding tube may be occluded Class II Applied Medical Technology Inc
Oct 6, 2025 Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... Class II Abbott Medical
Oct 6, 2025 OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materi... A labeling error was identified on the affected product. The expiration date on the kit box label... Class III POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC P...

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.