Class IIOngoingZ-2941-2026
BD SWITZERLAND SARL recalls 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus…
Products may not have received adequate sterilization processing.
BD SWITZERLAND SARLAug 19, 2026
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 845 recalls
Class IIOngoingZ-2933-2026
OBP Medical Corporation recalls OBP Medical
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
OBP Medical Corporatio…MAAug 19, 2026
Class IIOngoingZ-2915-2026
W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
W L Gore & Associates,…AZAug 19, 2026
Class IIOngoingZ-2914-2026
W L Gore & Associates, Inc. recalls GORE VIABIL Short Wire Biliary Endoprosthesis
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
W L Gore & Associates,…AZAug 19, 2026
Class IIOngoingZ-2911-2026
Contego Medical, Inc recalls Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Em…
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction;…
Contego Medical, IncNCAug 12, 2026
Class IIOngoingZ-2896-2026
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Control
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linea…
Aniara Diagnostica LLCOHAug 12, 2026
Class IIOngoingZ-2895-2026
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Calibrator
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linea…
Aniara Diagnostica LLCOHAug 12, 2026
Class IIOngoingZ-2894-2026
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin AMR Verification Kit
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linea…
Aniara Diagnostica LLCOHAug 12, 2026
Class IIOngoingZ-2861-2026
Nuclein LLC recalls Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/C…
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Nuclein LLCTXAug 12, 2026
Class IIOngoingZ-2840-2026
Boston Scientific Corporation recalls Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026
Class IIOngoingZ-2839-2026
Boston Scientific Corporation recalls Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN:…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026
Class IIOngoingZ-2838-2026
Boston Scientific Corporation recalls Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:…
Potential for breach in sterile barrier of device packaging.
Boston Scientific Corp…MAAug 12, 2026