The Recall Desk
HighFDA (Devices)·Z-0779-2021·Announced 2021-01-13

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.

What this means for you

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
Hazard
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.

See all 5 products in this recall →

Related recalls

Same manufacturer · Medline Industries Inc

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Same hazard · retained foreign object

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