CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Medline Iris Scissors, Single-Use, Curved, Standard recalled
Medline Industries LP - Northfield is recalling Medline Iris Scissors, Single-Use, Curved, Standard 4.5, distributed nationwide in the US. The recall was initiated on 21 Oct 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-0465-2025
- FDA event ID
- 95671
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Oct 2024
- FDA classified
- 14 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 Oct 2024 | Recall initiated by company | |
| 14 Nov 2024 | Classified by FDA | +24 days |
| 20 Nov 2024 | 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
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
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
Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Where it was distributed
US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.
Nationwide AlabamaArkansasColoradoConnecticutFloridaIowaIndianaKansasLouisianaMassachusettsMissouriNorth CarolinaNew YorkOklahomaOregonRhode IslandTennesseeTexasVirginiaWashington
Questions about this recall
Why was it recalled?
Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Which lots are affected?
UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787
Where was it sold?
US Nationwide distributions in the states of AL, AR, CO, CT, FL, IA, IN, KS, LA, MA, MO, NC, NY, OK, OR, RI, TN, TX, VA, WA, WY.
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.
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