Open, ClassifiedPosted Nov 19, 2025·Initiated Sep 26, 2025
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402
Product Description: A clear, plastic capillary blood collection tube
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Root cause: Process change control
Recalling firm: ASP Global, LLC. dba Anatomy Supply Partners, LLC.Type: Tube, Collection, Capillary BloodDistribution: Distribution US nationwide and Canada.Recall #Z-0564-2026
Open, ClassifiedPosted Nov 19, 2025·Initiated Sep 26, 2025
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Root cause: Process change control
Recalling firm: ASP Global, LLC. dba Anatomy Supply Partners, LLC.Type: Tube, Collection, Capillary BloodDistribution: Distribution US nationwide and Canada.Recall #Z-0565-2026
Open, ClassifiedPosted Nov 19, 2025·Initiated Sep 26, 2025
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Root cause: Process change control
Recalling firm: ASP Global, LLC. dba Anatomy Supply Partners, LLC.Type: Tube, Collection, Capillary BloodDistribution: Distribution US nationwide and Canada.Recall #Z-0566-2026
Open, ClassifiedPosted Nov 19, 2025·Initiated Sep 26, 2025
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Root cause: Process change control
Recalling firm: ASP Global, LLC. dba Anatomy Supply Partners, LLC.Type: Tube, Collection, Capillary BloodDistribution: Distribution US nationwide and Canada.Recall #Z-0567-2026
Open, ClassifiedPosted Nov 19, 2025·Initiated Oct 7, 2025
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Reason: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Root cause: Nonconforming Material/Component
Recalling firm: Meridian Bioscience IncType: C. Difficile Nucleic Acid Amplification Test AssayDistribution: US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.Recall #Z-0568-2026
Open, ClassifiedPosted Nov 19, 2025·Initiated Oct 7, 2025
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Reason: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Root cause: Nonconforming Material/Component
Recalling firm: Meridian Bioscience IncType: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen TestDistribution: US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama.Recall #Z-0569-2026
Open, ClassifiedPosted Nov 19, 2025·Initiated Aug 19, 2025
Brand Name: Vacuette
Product Name: 8 ml CAT Serum Separator Clot Activator
Model/Catalog Number: 455071P
Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
Reason: Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.
Root cause: Labeling Change Control
Recalling firm: Greiner Bio-One North America, Inc.Type: Tubes, Vials, Systems, Serum Separators, Blood CollectionDistribution: U.S.: AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, VA and WY.
O.U.S.: NoneRecall #Z-0571-2026
Open, ClassifiedPosted Nov 18, 2025·Initiated Oct 20, 2025
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Reason: 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.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Activated Whole Blood Clotting TimeDistribution: US Nationwide distribution in the states of Hawaii and New York.Recall #Z-0539-2026
Open, ClassifiedPosted Nov 18, 2025·Initiated Sep 2, 2025
Tribio Implant 7.5mm x 40mm REF M80 SB008
UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630
Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
Reason: Due to incorrect product label (Incorrect product name identified on outer packaging).
Root cause: Process control
Recalling firm: Berkeley Advanced Biomaterials, LLCType: Filler, Bone Void, Calcium CompoundDistribution: U.S. Nationwide distribution in the state of TN.Recall #Z-0540-2026
Open, ClassifiedPosted Nov 18, 2025·Initiated Sep 22, 2025
DxFLEX Flow Cytometer Catalog Number C78500
UDI-DI code: 15099590754013
The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
Reason: 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.
Root cause: Under Investigation by firm
Recalling firm: Beckman Coulter Inc.Type: Flow Cytometric Reagents And Accessories.Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.Recall #Z-0541-2026
Open, ClassifiedPosted Nov 18, 2025·Initiated Oct 8, 2025
REF: CC286297 or BS737162
Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
Reason: Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
Root cause: Software design
Recalling firm: Cellavision ABType: Device, Automated Cell-LocatingDistribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR.Recall #Z-0542-2026 Open, ClassifiedPosted Nov 17, 2025·Initiated Aug 4, 2025
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
Reason: 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.
Root cause: Process change control
Recalling firm: Merit Medical Systems, Inc.Type: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDistribution: US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, MS, WV, SD, DE, NV, ND.
OUS: United Arab Emirates, Australia, Italy, Spain, Sweden, Norway, Germany, France, Belgium, Netherlands, Thailand, New Zealand, Mexico, Puerto Rico, Canada, Korea, Republic of, South Africa, Qatar, Iceland, United Kingdom, Viet Nam, Slovakia, Guam, Oman, Portugal, Madagascar, Saudi Arabia, Finland, Cyprus, Switzerland, Taiwan, China, JapanRecall #Z-0533-2026 Open, ClassifiedPosted Nov 17, 2025·Initiated Oct 1, 2025
Brand Name: ReQuest Measles IgG
Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay
Model/Catalog Number: 01-190
Software Version: N/A
Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma
Component: not a component
Reason: Due to distributing the measles IgG IVD without a premarket approved/cleared.
Root cause: No Marketing Application
Recalling firm: Quest International, Inc.Type: Enzyme Linked Immunoabsorbent Assay, Rubeola IggDistribution: All products were distributed in the United States. (Utah, Washington).Recall #Z-0534-2026
Open, ClassifiedPosted Nov 17, 2025·Initiated Sep 5, 2025
Brand Name: Equinoxe Ergo
Product Name: Adjustable Angle rTSA Reamer, 42mm
Model/Catalog Number: 321-59-42
Software Version: N/A
Product Description: rTSA Reamer, 42mm
Component: Not a component
Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Root cause: Release of Material/Component prior to receiving test results
Recalling firm: Exactech, Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: U.S.: SC
O.U.S.: N/ARecall #Z-0535-2026
Open, ClassifiedPosted Nov 17, 2025·Initiated Sep 5, 2025
Brand Name: Equinoxe Ergo
Product Name: Adjustable Angle rTSA Reamer, 46mm
Model/Catalog Number: 321-59-46
Software Version: N/A
Product Description: rTSA Reamer, 46mm
Component: Not a component
Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Root cause: Release of Material/Component prior to receiving test results
Recalling firm: Exactech, Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: U.S.: SC
O.U.S.: N/ARecall #Z-0536-2026
Open, ClassifiedPosted Nov 17, 2025·Initiated Sep 5, 2025
Brand Name: Equinoxe Ergo
Product Name: Ergo Augments Pilot Tip Converter
Model/Catalog Number: 301-11-11
Software Version: N/A
Product Description: Pilot Tip Converter Piece
Component: Not a component
Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Root cause: Release of Material/Component prior to receiving test results
Recalling firm: Exactech, Inc.Type: Shoulder Prosthesis, Reverse ConfigurationDistribution: U.S.: SC
O.U.S.: N/ARecall #Z-0537-2026
Open, ClassifiedPosted Nov 17, 2025·Initiated Oct 6, 2025
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor
FOBT (Fecal Occult Blood Test)
Reason: 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.
Root cause: Process control
Recalling firm: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCType: Multi-Analyte Controls, All Kinds (Assayed)Distribution: USA: AK AL,AR,AZ, CA,CO,CT,DC,DE,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, ,WI, WV, WY,
Canada: AB, ONRecall #Z-0538-2026
Open, ClassifiedPosted Nov 14, 2025·Initiated Oct 13, 2025
TMJ Bilateral Implant
REF: CHG020
Sterile EO, Rx Only
Reason: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Root cause: Process control
Recalling firm: TMJ Solutions IncType: Joint, Temporomandibular, ImplantDistribution: US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA
OUS: Canada, Spain, Brazil,Recall #Z-0488-2026
Open, ClassifiedPosted Nov 14, 2025·Initiated Oct 17, 2025
Multichem ID-B. Model/Catalog Number: SR103B
Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
Reason: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
Root cause: Process control
Recalling firm: TECHNO-PATH MANUFACTURING LTD.Type: Multi-Analyte Controls UnassayedDistribution: US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.Recall #Z-0501-2026
Open, ClassifiedPosted Nov 14, 2025·Initiated Oct 17, 2025
Multichem ID-B. Model Number: SR103B.
Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
Reason: Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
Root cause: Process control
Recalling firm: TECHNO-PATH MANUFACTURING LTD.Type: Multi-Analyte Controls UnassayedDistribution: US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.Recall #Z-0502-2026