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 30, 2026 | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Halyard, Pain Pack. Kit Code: AMPK48-01. | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | Class II | AVID Medical, Inc. |
| Apr 30, 2026 | TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT... | An increase in incidence in complaints of a loose outer knife and reports of the outer knife beco... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Halyard, Towel Six Pack. Kit Code: AMTS70-01. | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | Class II | AVID Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT... | An increase in incidence in complaints of a loose outer knife and reports of the outer knife beco... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Num... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENF... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Num... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr ... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Num... | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were inc... | Class II | Avanos Medical, Inc. |
| Apr 30, 2026 | BD Pyxis MedStation ES Tower REF: 352 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 Mini REF: 1147-00 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedStation 4000 REF: 303 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| Apr 30, 2026 | BD Pyxis MedStation ES REF: 323 Medication cabinet | Fingerprint scanner may overheat to a temperature to cause 1st degree burn. | Class II | CareFusion 303, Inc. |
| 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 |
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.