Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 12, 2025 | Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA i... | Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary inj... | Class II | Immunotech A.S. |
| Jun 12, 2025 | ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL | Due to defects (bubbles/voids) identified during standard finished goods testing | Class II | Johnson & Johnson Vision Care, Inc. |
| Jun 12, 2025 | Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di... | Class II | Encore Medical, LP |
| Jun 12, 2025 | Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di... | Class II | Encore Medical, LP |
| Jun 11, 2025 | DA VINCI PACK URO/PROSTATE. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | CT DAVINCI. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | GS ENDOSCOPY PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | DAVINCI UROLOGY. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | CARDIAC ROBOT PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for us... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Jun 11, 2025 | GENERAL ROBOTIC PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Con... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Jun 11, 2025 | HVI CARDIAC ROBOT PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous ... | Out of specification stability test result for the Caphosol B solution from process validation lots | Class II | RECORDATI RARE DISEASES INC. |
| Jun 11, 2025 | LAPAROSCOPIC GYN. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAPAROSCOPIC TRAY. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | ROBOTIC URO/GYN PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with t... | Devices had an unapproved slabbing software function enabled for use. | Class II | FUJIFILM Healthcare Americas Corporation |
| Jun 11, 2025 | Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. End... | The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, h... | Class II | CooperSurgical, Inc. |
| Jun 11, 2025 | LAPAROSCOPY PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | GYN LAPAROSCOPY PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | PARTIAL NEPHRECTOMY PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | ROBOTIC PROSTATECTOMY PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | GEN LAPAROSCOPY PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | GENERAL LAPAROSCOPY TRAY. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | MAJOR THORACOSCOPY BASIN. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAPAROSCOPIC PROSTATECTOMY. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | GYN ROBOTIC PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAVH PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | LAP CHOLE PACK. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 11, 2025 | PACK GENERAL ROBOTIC. Medical convenience kit. | CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration. | Class II | AVID Medical, Inc. |
| Jun 10, 2025 | Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F... | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device s... | Class II | Boston Scientific Corporation |
| Jun 10, 2025 | BostonSight SCLERAL Lens | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. | Class II | Boston Foundation For Sight |
| Jun 10, 2025 | BostonSight PROSE Lens. | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. | Class II | Boston Foundation For Sight |
| Jun 10, 2025 | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model Number 40KWFXPLUS.004, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model Number 40KWFXPLUS.002, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 ... | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 10, 2025 | Model Number 40KWFX, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
| Jun 10, 2025 | Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resis... | Class II | SEDECAL SA |
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.