Sterile endoscopy trays recalled for potential blade packaging puncture
Medline is recalling sterile procedural trays labeled GENERAL ENDOSCOPY because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.
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 recall for a risk-of-harm medical device used in invasive endoscopy procedures. Sterility compromise from blade puncture poses potential infection risk to patients, but no illnesses or injuries have been reported to date.
Plain-English summary
Medline Industries is recalling Sterile Procedural Trays labeled GENERAL ENDOSCOPY (Item Number DYNJ903826D) due to a defect where sterile blades within the kits have the potential to puncture the outer foil layer of the sterile packaging.
Affected units were distributed worldwide, including the United States, Canada, Japan, Mexico, Panama, Turks & Caicos, and the United Arab Emirates. The recall involves 48 cases containing 96 total units with Lot Number 22IBR004.
Compromise of the sterile outer packaging layer could allow contaminants to reach the blade and internal contents of the procedural tray. Healthcare facilities and practitioners who have received these trays should discontinue use and contact Medline Industries for replacement units.
The recalled product
- Product
- Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
- 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 (4)
- Item Number: DYNJ903826D
- Case UDI/GTIN: 40195327177790
- Unit UDI/GTIN: 10195327177799
- Lot Number: 22IBR004
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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