CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report
Medline Leg recalled by MEDLINE INDUSTRIES, LP
MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Leg. The recall was initiated on 19 Oct 2023 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-0533-2024
- FDA event ID
- 93306
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Oct 2023
- FDA classified
- 12 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 19 Oct 2023 | Recall initiated by company | |
| 12 Dec 2023 | Classified by FDA | +54 days |
| 20 Dec 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Undeclared latex
Product as listed by the FDA
Medline Leg bag, REF DYND12574
Where it was distributed
US and Panama
Questions about this recall
Is Medline Leg recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Leg on 19 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0533-2024.
Why was it recalled?
Undeclared latex
Which lots are affected?
UDI/DI 40080196990338 (case), 10080196990337 (insert), Lot Numbers: 48623040001, 48623050001, 48623060001, 48623080001
Where was it sold?
US and Panama
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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