Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 17, 2025 | Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Mod... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 17, 2025 | MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Ca... | Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation | Class II | CARIS LIFE SCIENCES |
| Jun 17, 2025 | QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, ... | Dipstick strep A test has potential for false positive results. | Class II | Quidel Corporation |
| Jun 17, 2025 | i-view video laryngoscope. Model Number: 8008000. The i-view video laryng... | Potential for faulty devices as a result of depleted batteries. | Class I | Intersurgical Inc |
| Jun 17, 2025 | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Num... | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. ... | Class II | Medtronic, Inc. |
| Jun 16, 2025 | HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... | Class I | Draeger, Inc. |
| Jun 16, 2025 | SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE01... | SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due t... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 16, 2025 | Biofinity Toric Multifocal Contact Lens | Lens blisters may have an incomplete or leaking seal which may render them unsterile. | Class II | CooperVision, Inc. |
| Jun 16, 2025 | BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (... | Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the... | Class II | BD SWITZERLAND SARL |
| Jun 16, 2025 | SafeStar 60A Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... | Class I | Draeger, Inc. |
| Jun 16, 2025 | SafeStar 55 Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... | Class I | Draeger, Inc. |
| Jun 16, 2025 | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design e... | Class II | Medtronic MiniMed, Inc. |
| Jun 16, 2025 | Biofinity XR Toric Contact Lens | Lens blisters may have an incomplete or leaking seal which may render them unsterile. | Class II | CooperVision, Inc. |
| Jun 16, 2025 | SafeStar 90 Plus Filter. Bidirectionally breathing system filter. | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... | Class I | Draeger, Inc. |
| Jun 13, 2025 | Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.01... | Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due ... | Class II | Volcano Corp |
| 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 12, 2025 | Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Prepara... | The firm issued a field safety notice after becoming aware of three lots of products not having q... | Class II | Bridge to Life Ltd |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITR... | Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than exp... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jun 12, 2025 | Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative m... | A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are... | Class II | Beckman Coulter Inc. |
| Jun 12, 2025 | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| 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 | 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 | PARTIAL NEPHRECTOMY PACK. 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 | 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 | 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 | ROBOTIC PROSTATECTOMY 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 | 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 | LAPAROSCOPIC TRAY. 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 | PARTIAL NEPHRECTOMY - ROBOTIC. 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. |
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.