CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Convenience kits Myringotomy Pack-lf DYNJ59097A recalled
Medline Industries is recalling Convenience kits Myringotomy Pack-lf DYNJ59097A, distributed nationwide in the US. The recall was initiated on 31 Jul 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-3209-2026
- FDA event ID
- 99667
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2026
- FDA classified
- 16 Sep 2026
- Reported
- 23 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 31 Jul 2026 | Recall initiated by company | |
| 16 Sep 2026 | Classified by FDA | +47 days |
| 23 Sep 2026 | 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
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
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
Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
Where it was distributed
US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
Questions about this recall
Why was it recalled?
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Which lots are affected?
UDI-DI 10198459046551 Lot 25FBU754
Where was it sold?
US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.
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 29 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
3 other products · FDA event 99667| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Convenience kits Anesthesia Pain PK League DYNJ67925A recalled | Medline Industries | Sterility | Nationwide | |
| CLASS II | Convenience kits Minor Pack DYNJ58421A Springhill Minor recalled | Medline Industries | Sterility | Nationwide | |
| CLASS II | Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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