Device recall enforcement reports
The weekly enforcement reports for device recalls, with the recall class. 40,113 records; openFDA updated it 2026-10-05. About this dataset
Newest records
- Class II35,372
- Class I3,655
- Class III1,029
- Not Yet Classified1
- Philips PIC iX Essentials REF:867093
Philips North America · Due to software malfunction, patient information system may freeze and become unresponsive.
- Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufa…
Howmedica Osteonics Corp. · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential…
- Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm…
F & A Foundation · Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.
- REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Stryker Sustainability Solutions · Reusable access port system may crack or seperate during use.
- Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;
Mirion Technologies (Capintec), Inc. · Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5…
- ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR IN…
Howmedica Osteonics Corp. · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential…
- ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT…
Howmedica Osteonics Corp. · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential…
- REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
Stryker Sustainability Solutions · Reusable access port system may crack or seperate during use.
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…
GE Healthcare · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, stud…
- Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US
PI CARDIA LTD · Transfemoral catheter, positing arm may detached due to weld issue.
- MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Bayer Medical Care, Inc. · Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
- Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEM…
Wilson-Cook Medical Inc. · Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
- Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Maquet Cardiopulmonary Gmbh · The packaging may not consistently maintain sterile barrier integrity.
- Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU…
Abiomed, Inc. · The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
- Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp. · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential…
- TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Howmedica Osteonics Corp. · Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential…
- IV Non-Dedicated Gravity Administration Sets with drip chambers
ICU Medical, Inc. · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chlorid…
- Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
GE Healthcare · Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, stud…
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.