Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 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 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 29, 2026 | Plum Duo Infusion Pump, 40002-0401 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the cl... | Class II | ICU Medical, Inc. |
| Apr 29, 2026 | Plum Duo Precision IV Pump, 40002-0403 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the cl... | Class II | ICU Medical, Inc. |
| Apr 29, 2026 | Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x... | Reusable electrodes may not meet expected performance levels. | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 29, 2026 | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 | Sterile anchors my lack sterility assurance. | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 29, 2026 | Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS ST... | Reusable electrodes may not meet expected performance levels. | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 29, 2026 | Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm A... | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mah... | Class II | Mozarc Medical US LLC |
| Apr 28, 2026 | Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power... | Firmware issue may result in intermittent loss or degradation of powered functionality when paire... | Class II | Ferno-Washington Inc |
| Apr 28, 2026 | SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: ... | A single lot of expired syringes were distributed due to a distribution system control failure. | Class II | Mentor Texas LP |
| Apr 28, 2026 | Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72... | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 28, 2026 | Integris-Allura system; System Code Description (Model Numbers): Integris CV ... | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 28, 2026 | Philips Azurion systems not configured with an optional auxiliary pan handle.... | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table move... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 28, 2026 | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 a... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Apr 27, 2026 | Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/C... | Due to device not having FDA Clearance | Class II | Prismatik Dentalcraft, Inc. |
| Apr 27, 2026 | Medline convenience kits: PORT A CATH DYNJ906818A | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16... | 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 EYE DYNJ905154I TUBAL LIGATION CDS CD... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| Apr 27, 2026 | Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ... | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may ... | Class II | Medline Industries, LP |
| 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 |
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.