CLASS II Device recall · Reported 13 Jan 2021 · FDA Enforcement Report

Simple Neck Dissection recalled by Medline Industries

Medline Industries is recalling Simple Neck Dissection. The recall was initiated on 13 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 20GBF988 (Expiration 06/30/2024); 20HBM404 (Expiration 06/30/2024); 20JBG876 (Expiration 09/30/2024)
Quantity recalled90

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0780-2021
FDA event ID
86826
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Terminated
Recall initiated
13 Nov 2020
FDA classified
7 Jan 2021
Reported
13 Jan 2021
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

13 Nov 2020Recall initiated by company
7 Jan 2021Classified by FDA+55 days
13 Jan 2021Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The cylindrical sponge component is not x-ray detectable.

Product as listed by the FDA

Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Where it was distributed

Foreign distribution only - Canada.

Questions about this recall

Is Simple Neck Dissection recalled?

Yes. Medline Industries recalled Simple Neck Dissection on 13 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0780-2021.

Why was it recalled?

The cylindrical sponge component is not x-ray detectable.

Which lots are affected?

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

Where was it sold?

Foreign distribution only - Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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