FDA-Device2026-09-09Class IIPACKAGING DEFECT

Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators

OTHERNationwide distributionMedical devices

What this means

Medline's blood draw and phlebotomy kits contain antiseptic applicators (BD ChloraPrep Clear and FREPP Clear) with wrinkles in the paper packaging that may compromise the sterile barrier. If the packaging is damaged, the applicators could be exposed to bacterial or microbial contamination before use.

Check if you have any affected Medline Convenience Kits using the catalog numbers listed in the recall (DYLAB1081, DYNDB3005D, DYNDB3005F, DYNDB3006C, DYNDB3007C, and others).
Do not use kits from the affected lot numbers; contact your healthcare facility or Medline for replacement kits.
If a kit from a recalled lot was already used on a patient, report the lot number to your healthcare provider or infection control team.

The agency's original wording

Hazard

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Intended for

All ages

Illnesses reported

None reported

Sold states

US Nationwide distribution.

Affected count

996692 kits

Manufactured in

3 Lakes Dr, N/A, Northfield, IL, United States

Products

Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: DYNDB3005F; 4) DOUBLE RED CELL PHLEBOTOMY KIT, Catalog Number: DYNDB3006C; 5) PLATELET PHLEBOTOMY KIT, Catalog Number: DYNDB3007C; 6) WHOLE BLOOD KIT, Catalog Number: DYNDB3041D; 7) PHLEBOTOMY, Catalog Number: DYNDB3044D; 8) PHLEBOTOMY, Catalog Number: DYNDB3044F; 9) DONATION - WB, Catalog Number: DYNDB3086D; 10) DONATION - ALYX/TRIMA W/O TOUR, Catalog Number: DYNDB3088B; 11) THERAPEUTIC NFT, Catalog Number: DYNDB3100; 12) BLOOD CULTURE TRAY ADULT, Catalog Number: DYNDH1194A; 13) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1444D; 14) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1445C; 15) BLOOD CULTURE KIT, Catalog Number: DYNDH1462B; 16) BLOOD CULTURE ADULT, Catalog Number: DYNDH1619A; 17) BLOOD CULTURE PEDI, Catalog Number: DYNDH1620A; 18) BLOOD CULTURE KIT, Catalog Number: DYNDH1622C; 19) BLOOD CULTURE KIT, Catalog Number: DYNDH1622D; 20) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1626B; 21) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1694A; 22) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1695; 23) BLOOD CULTURE KIT, Catalog Number: DYNDH1708A; 24) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1714A; 25) BLOOD CULTURE KIT, Catalog Number: DYNDH1715B; 26) BLOOD CULTURE KIT, Catalog Number: DYNDH1723; 27) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740A; 28) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740B; 29) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741A; 30) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741B; 31) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1771A; 32) BLOOD CULTURE KIT, Catalog Number: DYNDH1805B; 33) BLOOD CULTURE KIT, Catalog Number: DYNDH1817A; 34) BLOOD CULTR KT DIVRSN DEVICE, Catalog Number: DYNDH1866; 35) BLOOD CULTURE KIT, Catalog Number: DYNDH1867; 36) BLOOD CULTURE KIT, Catalog Number: DYNDH1884; 37) PHLEBOTOMY BLOOD CULTURE KIT, Catalog Number: DYNDH1908; 38) BLOOD CULTURE KIT, Catalog Number: DYNDH1912; 39) BLOOD CULTURE KIT, Catalog Number: DYNDH1940; 40) BLOOD CULTURE KIT W/O BOTTLES, Catalog Number: DYNDH1985; 41) BLOOD CULTURE KIT, Catalog Number: DYNDH1988; 42) BLOOD CULTURE, Catalog Number: DYNDH2002; 43) BLOOD CULTURE W/NO IV, Catalog Number: DYNDH2016; 44) BLOOD CULTURE W/IV, Catalog Number: DYNDH2017; 45) BLOOD CULTURE KIT, Catalog Number: DYNDH2023; 46) BLOOD CULTURE KIT, Catalog Number: DYNDH2028; 47) BLOOD CULTURE KIT, Catalog Number: DYNDH2030; 48) BLOOD CULTURE KIT, Catalog Number: DYNDH2048; 49) BLOOD CULTURE KIT, Catalog Number: DYNDH2059; 50) BLOOD CULTURE KIT 450, Catalog Number: DYNDH2074; 51) BLOOD CULTURE-NB, Catalog Number: DYNDH2089

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3063-2026

More Medline recalls

FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
FDA-Device2026-09-09
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FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
FDA-Device2026-09-09
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FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for potential contamination

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