Recalls today

Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);

Quantity: 16697 units (492 USA, 16205 OUS)

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;

Recall number Z-3146-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators

Quantity: 6,420

Distribution: US Nationwide distribution in the states of OH, IN, NC.

Recall number Z-3181-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.

Quantity: 182

Distribution: US Nationwide distribution in the states of Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, , Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Vermont.

Recall number Z-3164-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM

Quantity: 7,5966 units

Distribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel …

Recall number Z-3182-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24JP 21-7600-24JP 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24

Quantity: 185,688 units

Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, LA, MI, MO, MS, TN, TX, VA, WI and the countries of Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden.

Recall number Z-3212-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100

Quantity: 3000 Final Count (in EA)

Distribution: US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.

Recall number Z-3180-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3195-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000

Quantity: 475 units

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3189-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

Quantity: 2

Distribution: US Nationwide distribution in the states of FL, CO.

Recall number Z-3178-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;

Quantity: 80 kits

Distribution: Domestic: IL, NC, VA, WY;

Recall number Z-3152-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ38145F

Quantity: 447 kits

Distribution: US Nationwide distribution.

Recall number Z-3123-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3198-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F

Quantity: 459

Distribution: US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.

Recall number Z-3208-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.

Quantity: 10,941 units

Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.

Recall number Z-3129-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions

Quantity: 1298 systems

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3167-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Philips Patient Information Center iX REF:866389

Quantity: 7359 Units

Distribution: Worldwide - US Nationwide distribution including in the states and territories 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, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Andorra, Utd. Arab. Emir., Argentina, Austria, Australia, Aruba, Bosnia-Herz., Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep, Algeria, Estonia, Spain, Finland, Fiji, Faroe …

Recall number Z-3141-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM

Quantity: 25746 units

Distribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel …

Recall number Z-3184-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions

Quantity: 169 systems

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3170-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3203-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 11171447* 7613203021234 37613203021242 BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites 11426965* 10885403232558 50885403232556 BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sites 2260-0500 7613203012591 37613203012608 BD Alaris Pump Infusion Set, PE Lined Tubing 24600-0007 10885403241970 50885403241978 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 2278-0500 10885403223266 50885403223264 BD Alaris Pump Infusion Blood Set, 200 Micron Filter 2477-0007 7613203019460 37613203019478 BD Alaris Pump Infusion Blood Set, 180 Micron Filter, SmartSite Y-site 22603-B007T 10885403240942 50885403240940 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 24010-0007T 10885403271021 50885403271029 BD Alaris Pump Infusion Set, Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite Y-sites 24301-0007T 10885403223198 50885403223196 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, SmartSite Y-site 24601-B007T 10885403240959…

Quantity: 94,230,757

Distribution: U.S.: Nation-wide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia Belgium Bahrain Botswana Canada Cuba China France Germany Gibraltar Israel India Italy Japan Korea, Republic of Kuwait Mexico Malaysia Netherlands New Zealand Philippines Pakistan Qatar Saudi Arabia Singapore South Africa Switzerland Taiwan, Province of China Turkey United Arab Emirates United Kingdom

Recall number Z-3080-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25

Quantity: 27200

Distribution: US Nationwide distribution in the state of MI.

Recall number Z-3172-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

GM Helix Implant, REF: 109.984;

Quantity: 216

Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;

Recall number Z-3173-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100

Quantity: 4300 Final Count (in EA)

Distribution: US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.

Recall number Z-3179-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3202-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.

Quantity: 2,044 units

Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.

Recall number Z-3132-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions

Quantity: 250 systems

Distribution: Worldwide - US Nationwide distribution.

Recall number Z-3171-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Halyard IV START KIT NON-STERILE REF: KRIV26-02

Quantity: 288 units

Distribution: US Nationwide distribution in the state of NE.

Recall number Z-3108-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

IV Sets with drip chambers

Quantity: 56,553,672

Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Recall number Z-3163-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Quantity: 12,156 US

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

Recall number Z-3205-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605300; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615120; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615150; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615200; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615240; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655120; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655150; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655200; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655240; Power-Trialysis Short-Term Straight Dialysis Catheter Full Procedure Tray, REF: 5605200G; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200G; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150G; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855150; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855240; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855300; Power-Trialysis Slim-Cath…

Quantity: 149521

Distribution: US: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY, IA, NH, NY, KS, HI, NE, MN, MT, WY, AR, RI, WV, UT, PR, DE, CT, ME, DC, ND, NM, SD

Recall number Z-2984-2026 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.