CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Medline convenience kit labeled as: Foot Ankle recalled
Medline Industries is recalling Medline convenience kit labeled as: Foot Ankle, distributed nationwide in the US. The recall was initiated on 11 Sep 2026 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-0189-2027
- FDA event ID
- 99983
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2026
- FDA classified
- 15 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Sep 2026 | Recall initiated by company | |
| 15 Oct 2026 | Classified by FDA | +34 days |
| 21 Oct 2026 | Published 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
Discrepancy in the shelf-life of a component
Product as listed by the FDA
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Where it was distributed
US Nationwide distribution in the state of NY.
Questions about this recall
Why was it recalled?
Discrepancy in the shelf-life of a component
Which lots are affected?
UDI/DI 10195327174156 (each) 40195327174157 (case), Lot Number 22GBW912
Where was it sold?
US Nationwide distribution in the state of NY.
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 27 Oct 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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