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.

DateProductReasonClassFirm
Apr 30, 2026 Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI ... Due to incorrect shelf-life expiration date. Class II Advanced Bionics, LLC
Apr 30, 2026 BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 BD Pyxis Mini Main REF: 349 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Class II CareFusion 303, Inc.
Apr 30, 2026 Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722... It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 30, 2026 Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (72206... It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Apr 29, 2026 REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The... Due to software issues where does not handle combo assay results. The software may replace the f... Class II Beckman Coulter Biomedical GmbH
Apr 29, 2026 Plum Solo Precision IV Pump, 40001-0401 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 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 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

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.