Medline Surgical Kits Recalled for Weak Seals Compromising Sterility
Medline is recalling 12,588 sterile surgical kits with Pure Pouch components that have weak seals, potentially compromising sterility and exposing patients and surgical teams to non-sterile instruments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of surgical kits with a concrete defect that poses direct risk of harm through potential sterility loss. No reported illnesses or injuries are stated in the source. Per the rubric, a risk-of-harm medical product without reported injury receives a High score.
Plain-English summary
Medline Industries, LP is recalling multiple models of sterile surgical convenience kits that contain Pure Pouch components. The affected kit models include the Medline Retrograde PK-22025203-LF, Cath Lab Pack, Sterile Loop Insertion Tray, Radiology Minor MVH, and Basic Pack.
The Pure Pouch component in these kits has been identified as having weak seals. If the seal fails, the sterility of the surgical instruments contained within the kit may be compromised, potentially exposing surgical teams and patients to non-sterile instruments during procedures.
Approximately 12,588 sterile kits were distributed nationwide across 23 states: Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and Wyoming.
Healthcare facilities that have received these kits should stop using them immediately and contact Medline Industries for replacement. Specific lot numbers and pack identification numbers for each recalled kit model are available through the FDA recall notice.
The recalled product
- Product
- Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 12,588
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. Pack #DYNJ47873K - lot numbers 23HBK868
- exp. 8/31/2027
- 23HBC082exp. 2/29/2028
- 23GBC462
- exp. 1/31/2028
- and 23DBK792
- exp. 11/30/2027
- exp. 1/31/2025
- exp. 12/31/2024
- and 23IBM893
- exp. 3/31/2025
- 23KLA748
- 1/31/2025
- 23KLA017
- 23JLA853
- 23JLA232. exp. 1/31/2025
- 23ILB006
- 23ILA201
- and 23HLA429
- exp. 5/31/2026
Distribution
Part of a larger recall action
This product is one of 9 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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