November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Pr
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 P
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear,
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Descr
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 725
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 725
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Mod
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Mode
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/C
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/C
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
ASP Global, LLC. dba Anatomy Supply Partners, LLC. recalls SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 610
Hazard: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
November 26, 2025Medical DevicesFDA
Auris Health, Inc recalls MONARCH Bronchoscope. Model Number: MBR-000211-B
Hazard: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
November 26, 2025Medical DevicesFDA
Cellavision AB recalls REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest
Hazard: Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
November 26, 2025Medical DevicesFDA
Beckman Coulter Inc. recalls DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for us
Hazard: Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
November 26, 2025Medical DevicesFDA
Berkeley Advanced Biomaterials, LLC recalls Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is
Hazard: Due to incorrect product label (Incorrect product name identified on outer packaging).
November 26, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Hazard: Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
November 26, 2025Medical DevicesFDA
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult
Hazard: A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.
November 26, 2025Medical DevicesFDA
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Ve
Hazard: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
November 26, 2025Medical DevicesFDA
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software V
Hazard: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
November 26, 2025Medical DevicesFDA
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software V
Hazard: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
November 26, 2025Medical DevicesFDA
Quest International, Inc. recalls Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01
Hazard: Due to distributing the measles IgG IVD without a premarket approved/cleared.
November 26, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,
Hazard: Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
November 26, 2025Medical DevicesFDA
Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS7801
Hazard: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.