Open, ClassifiedPosted Jun 12, 2025·Initiated May 12, 2025
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T;
SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T;
SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T;
Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T;
SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T;
SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T;
SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T;
Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T;
SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T;
SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T.
BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T;
BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET;
BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T;
BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T;
BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T;
BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T
Reason: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Root cause: Process control
Recalling firm: BD SWITZERLAND SARLType: Set, Administration, IntravascularDistribution: Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.Recall #Z-1970-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated May 12, 2025
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
Reason: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Root cause: Process control
Recalling firm: BD SWITZERLAND SARLType: Syringe, PistonDistribution: Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.Recall #Z-1971-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated May 12, 2025
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Reason: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Root cause: Process control
Recalling firm: BD SWITZERLAND SARLType: Syringe, PistonDistribution: Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.Recall #Z-1972-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated May 12, 2025
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Reason: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Root cause: Process control
Recalling firm: BD SWITZERLAND SARLType: Set, Administration, IntravascularDistribution: Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.Recall #Z-1973-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated May 12, 2025
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241;
BD TEXIUM (China), REF: 10012241 CHINA
Reason: Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Root cause: Process control
Recalling firm: BD SWITZERLAND SARLType: Set, Administration, IntravascularDistribution: Worldwide - US Nationwide distribution including in the states of MA, CA, IL, AK, AL, MO, FL, VA, ME, NC, MD, IA, WI, AZ, CO, KY, IN, TX, AR, NJ, NY, MT, NE, TN, PA, GA, WA, KS, MN, ID, SC, MI, SD, OH, WV, LA, ND, VT, GU, NV, UT, OK, OR, DE, NM, MS, WY and the countries of CA, AU, NZ, CN.Recall #Z-1974-2025
Open, ClassifiedPosted Jun 12, 2025·Initiated May 7, 2025
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release
system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic
Carpal Tunnel Release) System, Onyx Blade Assembly;
Common Name: SmartRelease Onyx;
Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);
Reason: Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Root cause: Under Investigation by firm
Recalling firm: MicroAire Surgical Instruments, LLCType: Knife, SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.Recall #Z-1975-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated May 1, 2025
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Reason: Product may have an off color affecting perfomance
Root cause: Under Investigation by firm
Recalling firm: Remel, IncType: Manual Antimicrobial Susceptibility Test SystemsDistribution: Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.Recall #Z-1947-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated Mar 24, 2025
Brand Name: Solana Bordetella Complete Assay
Product Name: Solana Bordetella kit
Model/Catalog Number: M308
Software Version: not applicable
Product Description: One sales unit (kit) contains materials for 48 tests.
One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes.
Component: No, not a component
Reason: It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP) results (only) of the assay.
Root cause: Under Investigation by firm
Recalling firm: Ortho-Clinical Diagnostics, Inc.Type: Bordetella Pertussis Dna Assay SystemDistribution: Please see the attached list "Consignee List_CL2025-120." Note: This file contains a specific tab, titled Shipping Summary, which contains the US and ex-US shipping summary.
One (1) Distributor was affected. The other four(4) Distributors were sent the notification for information only. QuidelOrtho sent the notification to their consignees because QuidelOrtho drop-shipped this product to their 31 consignees (Included in the Medical Facility total below).Recall #Z-1948-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated Apr 25, 2025
Brand Name: Tecfen Medical
Product Name: 15 degree Stab Knife
Model/Catalog Number: QKN1501
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives are used to make precise and fluid tight incisions during eye surgeries such as cataract procedures, vitreoretinal surgery, glaucoma surgery, corneal surgery, and oculoplastic procedures.
Component: No
Reason: Sterility assurance for Ophthalmic knives.
Root cause: Under Investigation by firm
Recalling firm: Tecfen MedicalType: Knife, OphthalmicDistribution: Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.Recall #Z-1949-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated Apr 25, 2025
Brand Name: Tecfen Medical
Product Name: 2.2mm Slit Knife, Angled
Model/Catalog Number: QKN2261
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye.
Component: No
Reason: Sterility assurance for Ophthalmic knives.
Root cause: Under Investigation by firm
Recalling firm: Tecfen MedicalType: Knife, OphthalmicDistribution: Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.Recall #Z-1950-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated Apr 25, 2025
Brand Name: Tecfen Medical
Product Name: 2.4mm Slit Knife, Angled
Model/Catalog Number: QKN2461
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye.
Component: No
Reason: Sterility assurance for Ophthalmic knives.
Root cause: Under Investigation by firm
Recalling firm: Tecfen MedicalType: Knife, OphthalmicDistribution: Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.Recall #Z-1951-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated Apr 25, 2025
Brand Name: Tecfen Medical
Product Name: 2.8mm Slit Knife, Angled
Model/Catalog Number: QKN2808
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye.
Component: No
Reason: Sterility assurance for Ophthalmic knives.
Root cause: Under Investigation by firm
Recalling firm: Tecfen MedicalType: Knife, OphthalmicDistribution: Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.Recall #Z-1952-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated Apr 25, 2025
Brand Name: Tecfen Medical
Product Name: 20G (1.2mm) MVR Sideport Knife Straight
Model/Catalog Number: QKN2312
Software Version: No software
Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport knives are used to create precision incisions in vitrectomy procedures.
Component: No
Reason: Sterility assurance for Ophthalmic knives.
Root cause: Under Investigation by firm
Recalling firm: Tecfen MedicalType: Knife, OphthalmicDistribution: Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.Recall #Z-1953-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated Apr 25, 2025
Brand Name: Tecfen Medical
Product Name: 2.0mm Crescent Knife Angled Bevel Up
Model/Catalog Number: QKN1010
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy.
Component: No
Reason: Sterility assurance for Ophthalmic knives.
Root cause: Under Investigation by firm
Recalling firm: Tecfen MedicalType: Knife, OphthalmicDistribution: Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.Recall #Z-1954-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated Apr 25, 2025
Brand Name: Tecfen Medical
Product Name: 3.2mm Slit Knife, Angled
Model/Catalog Number: QKN3261
Software Version: No software
Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye.
Component: No
Reason: Sterility assurance for Ophthalmic knives.
Root cause: Under Investigation by firm
Recalling firm: Tecfen MedicalType: Knife, OphthalmicDistribution: Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.Recall #Z-1955-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated May 15, 2025
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Reason: Contact lens insertion solution may lack sterility.
Root cause: Process control
Recalling firm: Contamac Solutions, Inc.Type: Products, Contact Lens Care, Rigid Gas PermeableDistribution: US Nationwide distribution in the states of AZ, CA, CO, FL, IL, IN, KS, KY, LA, ME, MI, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI.Recall #Z-1956-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated May 27, 2025
KWIK-STICK, Quality control kit for culture media,
Catalog Numbers 01065K, Oligella urethralis derived from ATCC 17960;
0621K, Staphylococcus aureus derived from NCTC 12493
Reason: Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
Root cause: Mixed-up of materials/components
Recalling firm: Microbiologics IncType: Kit, Quality Control For Culture MediaDistribution: US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.Recall #Z-1957-2025
Open, ClassifiedPosted Jun 11, 2025·Initiated May 9, 2025
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Reason: The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
Root cause: Under Investigation by firm
Recalling firm: Baxter Healthcare CorporationType: OtoscopeDistribution: US Nationwide distribution.Recall #Z-1962-2025
Open, ClassifiedPosted Jun 10, 2025·Initiated Apr 25, 2025
MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity client-server-based computer system that accesses stores and manages cardiovascular information.
Reason: The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data.
Root cause: Software design
Recalling firm: GE Medical Systems Information Technologies IncType: Detector And Alarm, ArrhythmiaDistribution: Worldwide - US Nationwide distribution.Recall #Z-1938-2025
Open, ClassifiedPosted Jun 10, 2025·Initiated May 22, 2025
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Reason: Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Root cause: Under Investigation by firm
Recalling firm: Stryker GmbHType: Rod, Fixation, Intramedullary And AccessoriesDistribution: Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.Recall #Z-1939-2025