CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report
Forcep, Std Str, Sterile Kelly recalled by Medline Industries
Medline Industries is recalling Forcep, Std Str, Sterile Kelly, distributed nationwide in the US. The recall was initiated on 13 Nov 2025 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-0922-2026
- FDA event ID
- 98066
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Nov 2025
- FDA classified
- 12 Dec 2025
- Reported
- 24 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 13 Nov 2025 | Recall initiated by company | |
| 12 Dec 2025 | Classified by FDA | +29 days |
| 24 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
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
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Where it was distributed
US Nationwide distribution in the states CA, CO, IL, KS, and MI.
Questions about this recall
Why was it recalled?
The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
Which lots are affected?
DYNJ04048, UDI-DI: 10193489195248(each), 20193489195245(case), Lot Number: 2023112290
Where was it sold?
US Nationwide distribution in the states CA, CO, IL, KS, and MI.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98066This product is part of a recall event; the main page for the event is Scissors, Or, Sharp/blunt, 5.5", Sterile recalled by Medline Industries.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Scissors, Or, Sharp/blunt, 5.5", Sterile recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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