Sterile Procedural Trays recalled due to potential sterile packaging puncture
Medline Industries is recalling Sterile Procedural Trays (IM NAIL) because sterile blades may puncture the outer foil layer of sterile packaging, potentially compromising sterility. No illnesses or injuries have been reported.
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: FDA Class II medical device with theoretical hazard (potential blade puncture of sterile packaging) and no reported illnesses or injuries. Meets Score 3 criteria: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP (Northfield) is recalling Sterile Procedural Trays labeled as IM NAIL (Item Number DYNJ901391D, Lot Numbers 22KBH254 and 22IBI253). Sterile blades within the trays have the potential to puncture the outer foil layer of the sterile packaging, which could compromise the sterility of the product.
The recalled trays were distributed worldwide, including throughout the United States and to Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. A total of 40 cases containing 40 units were affected.
No illnesses or injuries have been reported in connection with this recall. Consumers and healthcare providers who have received these trays should stop using them and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: IM NAIL
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (5)
- Item Number: DYNJ901391D
- Case UDI/GTIN: 40193489436595
- Unit UDI/GTIN: 10193489436594
- Lot Number: 22KBH254
- 22IBI253
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 38 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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