Medline Recalls Non-X-Ray Detectable Surgical Sponges in Convenience Kits
Medline Industries is recalling 88 surgical convenience kits because the cylindrical sponge component is not x-ray detectable. The affected products were distributed only in Canada.
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: The recall involves a medical device defect (non-x-ray detectable sponge) that poses a risk of retained foreign objects during surgery, which is a risk-of-harm product where injury has not yet been reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 88 units of the Resect. Intest. Laparo-LF, Model DYNJ42667A, a surgical convenience kit used in various procedures including cardiac, abdominal, and neck surgeries. The recall is due to a defect where the cylindrical sponge component is not x-ray detectable.
The affected products are identified by Lot 20GBA365, 20HBM367, and 20IBC934, all with an expiration date of 11/30/2024. The distribution pattern for this recall is foreign distribution only, specifically to Canada.
Healthcare providers and facilities that have received these products should stop using them immediately and contact Medline Industries for instructions on return or disposal. Patients who have had surgeries involving these specific kits should consult their healthcare provider if they have concerns regarding the detectability of the sponge component.
The recalled product
- Product
- Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 88
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)
- Lot 20GBA365 (Expiration 11/30/2024)
- 20HBM367 (Expiration 11/30/2024)
- 20IBC934 (Expiration 11/30/2024)
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Medline Industries Inc 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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