Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 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 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| 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 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 m... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| Apr 27, 2026 | BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 ... | This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hyd... | Class I | Becton Dickinson & Company |
| 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 |
| Apr 22, 2026 | Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in... | Class II | Intuitive Surgical, Inc. |
| Apr 22, 2026 | Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalo... | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of th... | Class II | Baxter Healthcare Corporation |
| Apr 22, 2026 | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N... | Labeling update concerning proximal clasp disconnection from the outer control tube which may pre... | Class I | Bolton Medical Inc. |
| Apr 22, 2026 | BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | Contamination to in-vitro diagnostic test may result in false positives. | Class II | BioFire Diagnostics, LLC |
| Apr 21, 2026 | Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in con... | The Adapter for Head Positioning accessory may become loose during patient positioning and uninte... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2026 | Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 | A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in ... | Class II | PFM MEDICAL INC. |
| Apr 21, 2026 | Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIA... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC K... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L ... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L... | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
| Apr 21, 2026 | PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included... | Class I | ARROW INTERNATIONAL, LLC |
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.