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 30, 2026 | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burr... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, bur... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burr... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, bur... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, bur... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, tre... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number... | Assayed Whole blood control contains labeling with incorrect performance range. | Class II | Accriva Diagnostics, Inc. |
| Apr 30, 2026 | TDC VELOCE", 25G 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 | Halyard, Eye Bag Pack. Kit Code: UIEB48-01. | 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 14 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 | Halyard, Drape Pack. Kit Code: LMDP36-01. | 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 20 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 Numbe... | 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 20 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 Numbe... | 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: 30-6316 | 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. |
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.