CLASS II ONGOING Device recall · Reported 16 Jun 2021 · FDA Enforcement Report
Medline Tissue Recovery Instrument Set recalled by Medline Industries
Medline Industries is recalling Medline Tissue Recovery Instrument Set, distributed in Wisconsin. The recall was initiated on 30 Apr 2021 and the FDA has classified it as Class II.
Check your package
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-1841-2021
- FDA event ID
- 87910
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2021
- FDA classified
- 9 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2021 | Recall initiated by company | |
| 9 Jun 2021 | Classified by FDA | +40 days |
| 16 Jun 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The devices may not meet the minimum required sterility assurance level.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
Where it was distributed
US Distribution to state of: WI.
Questions about this recall
Why was it recalled?
The devices may not meet the minimum required sterility assurance level.
Which lots are affected?
GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285
Where was it sold?
US Distribution to state of: WI.
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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