Browse Device Recalls
35,226 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,226 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 35,226 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 27, 2026 | Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ682... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED S... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESS... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DY... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline EBSI Kit EBSI1534 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: WT LAVH PACK DYNJ46609F | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ91082... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: DAVINCI MAIN DYNJ908031D | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Aligned Medical AMS16835 Fluids Kit RX | Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was ... | Class II | Windstone Medical Packaging, Inc. |
| Apr 27, 2026 | PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 | The recall is being conducted due to corrosion of the internal metallic spring within the sprayer... | Class II | Oculus Technologies of Mexico, S.A. de C.V. |
| Apr 24, 2026 | EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: ... | Blood pump inner package expiration date does not match the outer-correct expiration date, which ... | Class II | BERLIN HEART GMBH |
| Apr 24, 2026 | Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Ca... | The cannulation of the CCS screw is not centered. | Class II | Medartis AG |
| Apr 24, 2026 | CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer b... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Nu... | Due to unintentionally activated near infrared handheld camera when attempting to turn off illumi... | Class II | Intuitive Surgical, Inc. |
| Apr 24, 2026 | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) us... | Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on... | Class II | Bayer Medical Care, Inc. |
| Apr 24, 2026 | GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Prod... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - O... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, ... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual pack... | Class II | Devicor Medical Products Inc |
| Apr 24, 2026 | GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 24, 2026 | GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, ... | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 moni... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 23, 2026 | Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 108845... | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) p... | Class II | Covidien LLC |
| Apr 23, 2026 | Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the foll... | The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or c... | Class II | Kico Knee Innovation Company |
| Apr 23, 2026 | Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM RE... | Temperature probe devices lack FDA clearance. | Class II | Covidien LLC |
| Apr 23, 2026 | Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 | Temperature probe devices lack FDA clearance. | Class II | Covidien LLC |
| Apr 23, 2026 | Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Micr... | 3.0mm surgical knives labeled and packaged as 2.2mm surgical knives. | Class II | SSC- Surgical Specialties Corporation |
| Apr 23, 2026 | Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the foll... | The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion ... | Class II | Kico Knee Innovation Company |
| Apr 23, 2026 | Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 | Temperature probe devices lack FDA clearance. | Class II | Covidien LLC |
| Apr 23, 2026 | Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33... | Due to stain present on the surface of affected foley catheters. | Class II | C.R. Bard Inc |
| Apr 23, 2026 | OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X ... | Intervertebral body fusion system straight inserter failed to properly attach to affected cages, ... | Class II | Novapproach Spine, LLC |
| Apr 22, 2026 | Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS-... | Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray ... | Class II | Boston Scientific Neuromodulation Corporation |
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.