CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
ST IUD Removal Hook 10" (504090), Medline recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling ST IUD Removal Hook 10" (504090), Medline, distributed nationwide in the US. The recall was initiated on 12 Nov 2024 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-0759-2025
- FDA event ID
- 95843
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Nov 2024
- FDA classified
- 23 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 12 Nov 2024 | Recall initiated by company | |
| 23 Dec 2024 | Classified by FDA | +41 days |
| 1 Jan 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is ST IUD Removal Hook 10" (504090), Medline recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled ST IUD Removal Hook 10" (504090), Medline on 12 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0759-2025.
Why was it recalled?
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Which lots are affected?
UDI: 10653160327141 (ea) 00653160327144 (case); Lot 2023021390
Where was it sold?
US Nationwide distribution.
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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