The Recall Desk
SevereFDA (Devices)·Z-3057-2026·Announced 2026-09-09

Medline Blood Culture Kits Recalled for Potential Sterility Breach

Medline is recalling 3,650 blood culture kits nationwide due to potential packaging defects that may compromise sterility and expose patients to microbial contamination.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that potential health consequences include hospitalization and that severe infection could become life-threatening in rare cases, meeting the rubric criteria for a Severe (4) rating.

Plain-English summary

Medline Industries, LP is recalling 3,650 units of two blood culture kit models: the Blood Culture Tray Pediatric (Model DYNDH1193) and the Blood Culture Kit 2 w/Connect (Model DYNDH1487A). The recall covers kits distributed nationwide in the United States.

The recall is due to a potential breach of sterility in the packaging. Wrinkles in the paper lidding may extend to the seal area, which could compromise the sterile barrier. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.

Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using affected kits.

The recalled product

Product
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A
Affected units
3,650

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) DYNDH1193
  • UDI-DI: 10889942499953(each)
  • 40889942499954(case)
  • Lot Number: 24ABA808
  • 2) DYNDH1193
  • Lot Number: 24BBV222
  • 3) DYNDH1193
  • Lot Number: 24GBT333
  • 4) DYNDH1193
  • Lot Number: 24IBU725
  • 5) DYNDH1193
  • Lot Number: 23KBX578
  • 6) DYNDH1193
  • Lot Number: 23LBP536
  • 7) DYNDH1487A
  • UDI-DI: 10193489484311(each)
  • 40193489484312(case)
  • Lot Number: 25BMG311
  • 8) DYNDH1487A
  • Lot Number: 24AME318

Distribution

Distributed nationwide across the United States.

Same hazard · microbial contamination

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