The Recall Desk
HighFDA (Devices)·Z-0780-2021·Announced 2021-01-13

Medline Simple Neck Dissection Kit Recalled for Non-X-Ray Detectable Sponge

Medline Industries is recalling 90 units of Simple Neck Dissection kits because the cylindrical sponge component is not x-ray detectable.

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 with a defect (non-x-ray detectable sponge) that poses a risk of harm (retained foreign object) in a high-risk setting (surgery), but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries Inc is recalling 90 units of the Simple Neck Dissection, Model DYNJ47481C. This product is a convenience kit used in various surgeries, including cardiac, abdominal, and neck surgeries. The recall is due to the cylindrical sponge component not being x-ray detectable.

The affected lots are 20GBF988, 20HBM404, and 20JBG876, all with expiration dates in 2024. The distribution pattern for this recall is foreign distribution only, specifically to Canada.

Healthcare facilities and distributors in Canada should stop using the affected products and contact Medline Industries for further instructions. No specific illnesses or injuries are reported in the source text.

The recalled product

Product
Simple Neck Dissection, Model DYNJ47481C - 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
90

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 20GBF988 (Expiration 06/30/2024)
  • 20HBM404 (Expiration 06/30/2024)
  • 20JBG876 (Expiration 09/30/2024)

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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