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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.