Browse Device Recalls

1,683 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,683 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 1,683 FDA device recalls in 2026.

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DateProductReasonClassFirm
Aug 18, 2026 POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Doubl... Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. Class II Olympus Corporation of the Americas
Aug 11, 2026 Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... Class II Baxter Healthcare Corporation
Aug 11, 2026 Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... Class II Baxter Healthcare Corporation
Aug 10, 2026 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Aug 10, 2026 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3 Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Aug 10, 2026 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-51... Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Aug 10, 2026 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the ... Class II Fresenius Medical Care Renal Therapies Group, LLC
Aug 7, 2026 Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brillian... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spe... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuit... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 7, 2026 Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Bril... Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and B... Class II Philips North America Llc
Aug 6, 2026 LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... There is potential for a delay in AF Burden Alert notification affecting the server software whic... Class II Boston Scientific Corporation
Aug 6, 2026 LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... There is potential for a delay in AF Burden Alert notification affecting the server software whic... Class II Boston Scientific Corporation
Aug 6, 2026 LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LA... There is potential for a delay in AF Burden Alert notification affecting the server software whic... Class II Boston Scientific Corporation
Aug 6, 2026 ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Number... The linear actuator and rotational lock mechanism components may experience a mechanical failure ... Class II IMRIS Imaging Inc
Aug 6, 2026 ORT200, operating room table, including the ORT200 Covered Table Assembly, Re... The linear actuator and rotational lock mechanism components may experience a mechanical failure ... Class II IMRIS Imaging Inc
Aug 4, 2026 Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Ca... Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on t... Class II B Braun Medical Inc
Aug 4, 2026 Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digit... Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X... Class II Canon Medical System, USA, INC.
Jul 31, 2026 HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 103000... Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical catarac... Class II Johnson & Johnson Surgical Vision, Inc.
Jul 30, 2026 BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit ... After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or im... Class I Bard Access Systems, Inc.
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;... A positive drift in QC values within the reagent's stated 4-hour onboard stability period was ide... Class II Diagnostica Stago, Inc.
Jul 29, 2026 healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative... Test manufactured with an expired ingredient which may present as either a false negative or posi... Class II Healthmark Industries Co., Inc.
Jul 29, 2026 healthmark ProChek-II, Model Number PT-313, PT-201-12 Test manufactured with an expired ingredient which may present as either a false negative or posi... Class II Healthmark Industries Co., Inc.
Jul 24, 2026 Ami HTX Momentary absence of On-Screen "X-Ray On" banner during run readiness check. Class II Spectral Instruments Inc
Jul 24, 2026 Lago X Momentary absence of On-Screen "X-Ray On" banner during run readiness check. Class II Spectral Instruments Inc
Jul 23, 2026 Velys Enabling Tech Robotic-Assist Station REF: 451611001 Software issue within robotic controller which may cause unintended movement of the robotic arm d... Class II Medos International Sarl
Jul 22, 2026 FUJIFILM Synapse PACS software v7.4.310; radiological image processing system Software issue may cause the ruler measurement to be inaccurate. Class II FUJIFILM Healthcare Americas Corporation
Jul 22, 2026 Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation Software issue may cause measurements to be displayed inaccurately. Class II Merge Healthcare, Inc.
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... Class II Medline Industries, LP
Jul 20, 2026 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ... Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators.... 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.