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.

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DateProductReasonClassFirm
Jul 31, 2026 Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYN... Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Enterprise Archive V8, software product for receiving, archiving, and sending... Under certain conditions historical imaging data migrated from a legacy system may become incorre... Class II GE Healthcare
Jul 31, 2026 Philips Patient Information Center iX REF:866389 Due to software malfunction, patient information system may freeze and become unresponsive. Class II Philips North America
Jul 31, 2026 Workflow Core Services V8, intended to provide set of services for storage an... Under certain conditions historical imaging data migrated from a legacy system may become incorre... Class II GE Healthcare
Jul 31, 2026 SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 The 6Fr suction catheter could not pass through the samples smoothly. Class II WELL LEAD MEDICAL CO. LTD
Jul 31, 2026 Core Services Hub V8, a set of backend services including Cross Enterprise (X... Under certain conditions historical imaging data migrated from a legacy system may become incorre... Class II GE Healthcare
Jul 31, 2026 Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterilit... Class II Medline Industries, LP
Jul 31, 2026 Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 ... The packaging may not consistently maintain sterile barrier integrity. Class II Maquet Cardiopulmonary Gmbh
Jul 31, 2026 Centricity Enterprise Archive V2, V3, and V4, software product for receiving,... Under certain conditions historical imaging data migrated from a legacy system may become incorre... Class II GE Healthcare
Jul 31, 2026 Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 ... The packaging may not consistently maintain sterile barrier integrity. Class II Maquet Cardiopulmonary Gmbh
Jul 31, 2026 MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System... Some devices may not have been properly sterilized due to a manufacturing sterilization issue. Class II Bayer Medical Care, Inc.
Jul 31, 2026 Centricity PACS V2, V3, V4, V6, V7, software product is intended for the stor... Under certain conditions historical imaging data migrated from a legacy system may become incorre... Class II GE Healthcare
Jul 31, 2026 Philips PIC iX Essentials REF:867093 Due to software malfunction, patient information system may freeze and become unresponsive. Class II Philips North America
Jul 31, 2026 Centricity PACS Server V7, intended for managing digital medical images and a... Under certain conditions historical imaging data migrated from a legacy system may become incorre... Class II GE Healthcare
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 AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthop... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... Class II Datex-Ohmeda, Inc.
Jul 30, 2026 TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSER... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 ... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 1... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENO... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 8... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant compon... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Ortho... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F A... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... Class II Datex-Ohmeda, Inc.
Jul 30, 2026 Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, ... Device may not resume patient monitoring for at least 3 minutes following system restart. Issue c... Class II GE Medical Systems Information Technologies Inc
Jul 30, 2026 Et Control, Software option for anesthesia gas machine to achieve and maintai... Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... Class II Datex-Ohmeda, Inc.
Jul 30, 2026 Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9... Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... Class II Datex-Ohmeda, Inc.
Jul 29, 2026 CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transduc... Communication to recommend reviewing the IFU and ensuring that all treatment preparation and hand... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jul 29, 2026 AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freefle... Class II Windstone Medical Packaging, 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.

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.