Surgical Patties and Strips Recalled for Elevated Endotoxin Levels in Kits
Medline Industries is recalling SEPTOPLASTY PACK convenience kits nationwide due to higher-than-expected endotoxin levels in surgical patties and strips. The contamination may pose infection risks during surgical procedures.
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 with no reported illnesses or injuries. Elevated endotoxin in sterile surgical supplies poses a significant risk of infection or inflammatory response, placing this in the High category per the rubric for high-risk contamination without reported harm.
Plain-English summary
Medline Industries, LP (Northfield) is recalling SEPTOPLASTY PACK convenience kits (SKU DYNJ44759F, Lot Number 20JBD814) distributed nationwide in the United States and Canada.
The surgical patties and strips included in these kits were found to contain higher-than-expected levels of endotoxin, a substance produced by certain bacteria. These elevated levels may have resulted in finished products that do not meet required specifications for sterile surgical supplies.
Endotoxin contamination in products used during surgical procedures can pose a risk of infection or inflammatory response to patients. Healthcare facilities and surgical centers that received these kits should stop using them immediately and contact Medline Industries for instructions on return or disposal of affected units.
Patients who have already undergone surgery using materials from affected kits and experience any unusual symptoms should consult their healthcare provider.
The recalled product
- Product
- SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 40
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)
- UDI-DI: 10193489789935(each)
- 40193489789936(case)
- Lot Number: 20JBD814
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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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