Medline Surgical Shoulder Suspension Kits Recalled for Sterility Compromise
Medline is recalling 1,280 SHOULDER SUSPENSION surgical kits nationwide due to a defective perforated bag that fails to maintain sterility on the kit's exterior, potentially compromising the sterile contents inside.
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 recall involving sterility compromise in surgical kits. No illnesses or injuries have been reported, but the packaging defect creates a risk of contamination during surgical procedures, meeting the criteria for a high-severity risk-of-harm product.
Plain-English summary
Medline Industries is recalling 1,280 units of SHOULDER SUSPENSION surgical convenience kits nationwide. The affected kits are identified by Reorder Number DYNJSHOULDER, GTIN 10080196597383, and Lot # 22DBN321.
The recall is due to a defect in the kit's packaging. The kits contain a perforated bag that does not allow the exterior wrapping to maintain sterility. While the contents inside the kit wrapping are sterile, the outer wrapping is not. This packaging design can compromise the sterility assurance when the kit is opened or handled, potentially allowing non-sterile surfaces to contaminate the surgical instruments inside.
No illnesses or injuries related to this defect have been reported. Customers and healthcare facilities should immediately stop using these kits. Check inventory for the affected lot number and quarantine any units. Contact Medline Industries for replacement or proper disposal instructions.
The recalled product
- Product
- Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,280
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 (3)
- Reorder Number DYNJSHOULDER
- GTIN 10080196597383
- Lot # 22DBN321
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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