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.

Clear
DateProductReasonClassFirm
Jun 20, 2025 GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. Potential contamination with small burrs, which if detach could be inhaled and result in potentia... Class II Intersurgical Inc
Jun 20, 2025 GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine s... Unintended radial detector motion may occur during patient setup or during patient scan if system... Class II GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Jun 20, 2025 One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. Potential contamination with small burrs, which if detach could be inhaled and result in potentia... Class II Intersurgical Inc
Jun 20, 2025 GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography wi... GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 20, 2025 GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discover... Class II GE Medical Systems, LLC
Jun 19, 2025 M5 Corpus Power Wheelchair REF,120032 This recall is being reported retroactively. Power Platform firmware is missing specific drive in... Class II Permobil Inc
Jun 19, 2025 Portable X-ray system Some DIOX-602 units currently in use within the United States do not meet the minimum SSD require... Class II DIGIMED CO., LTD
Jun 18, 2025 Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. ... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator withou... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
Jun 18, 2025 Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated A... Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladde... Class II C.R. Bard Inc
Jun 18, 2025 Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model N... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Ellik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacua... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/C... There is the potential that the silicone implant may contain foreign material Class II Osteotec Limited
Jun 18, 2025 Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. ... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard e... Natus received two complaints of left side labeling show impedance for right side. Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Jun 18, 2025 Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the fol... In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... Class II Medtronic, Inc.
Jun 18, 2025 Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The E... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter access... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Di... Due to complaints their is the potential that irrigation solution may leaked into the handpiece ... Class II Stryker Corporation
Jun 18, 2025 Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the f... In prior SmartSync application versions, the Abort button stopped the test that was selected. Dur... Class II Medtronic, Inc.
Jun 18, 2025 Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuat... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
Jun 18, 2025 Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuat... Discrepancies between sterilization instructions in the Japanese language product package inserts... Class II Olympus Corporation of the Americas
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 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 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 KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 080... Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminu... Class II Microbiologics 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 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 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 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 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 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 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 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.

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.