Medline Neuro IR Surgical Kit Recalled Due to Weak Seals
Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.
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 a risk-of-harm product where injury has not yet been reported. Surgical sterility compromise poses significant potential harm, and no illnesses or injuries are documented in the source text.
Plain-English summary
Medline Industries is recalling Neuro IR Pack sterile surgical convenience kits because the Pure Pouch component has weak seals. If a seal fails, the sterility of the kit's contents may be compromised, potentially exposing patients to contamination during surgical procedures.
The recall involves 12,588 sterile kits with pack number DYNJ56073C that were distributed nationwide. Affected kits include lot number 23IDA509 (expiration 5/31/2026) and lot number 23DDC159 (expiration 11/30/2025).
The recalled product
- Product
- Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
- 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 (6)
- Pack #DYNJ56073C - lot numbers 23IDA509
- exp. 5/31/2026
- and 23DDC159
- exp. 11/30/2025
- UDI-DI each-10193489441833
- UDI-DI case-40193489441834.
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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