Medline surgical convenience kits recalled for inadequate exterior sterility
Medline is recalling surgical convenience kits because the perforated bag does not maintain sterility of the kit's exterior wrapping. Only the contents inside the wrapping are sterile.
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 Class II medical device recall for a sterility breach in surgical kits. Although no illnesses or injuries are reported, the defect creates a risk of contamination in critical surgical procedures, meeting the criteria for a high-risk product with unreported injury risk.
Plain-English summary
Medline Industries, LP is recalling surgical convenience kits labeled as MEDLINE PERF. ASSOC. CUT DOWN TRAY (Reorder Number BM17BAD) distributed nationwide. The affected lot is 22DBN972.
The recall is due to a defect in the kit's perforated bag. The bag does not allow the outside of the kit wrapping to remain sterile, meaning only the contents inside the wrapping are sterile. This creates a risk that exterior surfaces may become contaminated during use.
These kits are used in surgical settings where sterility is critical. Healthcare facilities and surgical centers that received these kits should verify they have the affected lot number and take appropriate action.
Consumers and healthcare providers with this product should stop using the affected lot and contact Medline Industries with questions.
The recalled product
- Product
- Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
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 (2)
- GTIN 10888277589490
- Lot # 22DBN972
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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