Medline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk
Medline is recalling approximately 1,048 medical procedure convenience kits that may become non-sterile if their protective pouch seal is compromised. The affected kits were packaged with breather pouches from lot 323080002.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall with a theoretical risk of non-sterile product use if the protective pouch seal is compromised. No illnesses, injuries, or deaths have been reported, making this a risk-of-harm scenario without actual reported harm.
Plain-English summary
Medline Industries is recalling 1,048 medical procedure convenience kits distributed nationwide in the United States, as well as in Canada and Panama. The affected kits were packaged with breather pouches bearing lot number 323080002.
The recall was initiated because these kits may become non-sterile if the vendor seal on the breather pouch is opened or compromised. Non-sterile medical procedure kits pose a risk of contamination if used in medical procedures.
The recalled kits include multiple SKUs with various reference numbers, including breast biopsy packs, septoplasty packs, and other surgical procedure kits. Affected lot numbers are listed by product type and reference number.
Healthcare facilities and healthcare providers should immediately stop using any affected kits and contact Medline Industries for replacement or disposal instructions.
The recalled product
- Product
- Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF D
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- contamination
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)
- a) DYNJ42735A
- UDI/DI 40888277226433 (each)
- 10888277226432 (case)
- Lot Numbers: 23LBP975
- b) DYNJ43457
- UDI/DI 40888277055309 (each)
- 10888277055308 (case)
- Lot Numbers: 23LBS052
- c) DYNJ46717A
- UDI/DI 40193489650014 (each)
- 10193489650013 (case)
- Lot Numbers: 24ABF270
- d) DYNJ46717A
- Lot Numbers: 23LBO013
- e) DYNJ53205B
- UDI/DI 40193489424851 (each)
- 10193489424850 (case)
- Lot Numbers: 24ABC805
- f) DYNJ53205B
- Lot Numbers: 23LBN742
Distribution
Distributed nationwide across the United States.
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