Medline Surgical Kits and Trays Recalled Due to Potential Sterility Defect
Medline Industries is recalling surgical kits and trays that may contain non-sterile irrigation solutions. Affected products were manufactured with certain component lots that have a potential sterility defect.
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: FDA Class I classification per agency designation. The rubric requires a minimum severity of 4 for Class I recalls. No illnesses, injuries, or deaths have been reported in the source text, so the score does not reach Critical.
Plain-English summary
Medline Industries, LP is recalling certain surgical kits, trays, and packs distributed nationwide. The recalled products include 40 variants used in diverse surgical procedures, including anterior access packs, arthroscopy trays, CVL insertion kits, extremity surgical packs, hand procedures, knee surgery kits, shoulder procedures, and other procedurally-focused surgical kits.
The recall was initiated due to the use of specific lots of Nurse Assist components during manufacturing: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. These component lots have a potential lack of sterility, which could result in the surgical solutions and kits being non-sterile.
The recall affects 14,280 units distributed nationwide across the United States, Puerto Rico, Canada, United Arab Emirates, and Panama. Product-specific lot numbers and UDI codes are available to identify affected inventory.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-defect
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) REF DYNJ64814A
- UDI/DI 40195327112807 (case)
- 10195327112806 (unit)
- Lot Numbers: 22FBD779
- 22JBN895
- b) REF DYNDH1629
- UDI/DI 40193489917360 (case)
- 10193489917369 (unit)
- Lot Numbers: 22ABP606
- c) REF DYNJ48587A
- UDI/DI 40889942313106 (case)
- 10889942313105 (unit)
- Lot Numbers: 22JBQ342
- 23ABL345
- 23CBJ954
- 23DBK384
- 23FBQ607
- d) REF CDS983313I
- UDI/DI 40193489424540 (case)
- 10193489424539 (unit)
Distribution
Distributed nationwide across the United States.
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