Z-0465-2025Class II

Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)

Name: Z-0465-2025 Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-10-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-10-21 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches) on 2024-10-21. FDA classified it as Class II and gives the reason as "Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0465-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-21
Posted: 2024-11-14
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases), DYNJ04049H (eaches)
Product code: LRW Scissors, General, Surgical
Reason for recall: Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: This is an expansion of recall RES 92881, which was originally initiated on April 30, 2024. Additional impacted customers were identified and notified on October 7, 2024. Customers were instructed to destroy any affected product on hand. The firm will issue credit for affected product.
Quantity in commerce: 69,611
Distribution: 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.
Product codes and lots: UDI-DI: 10080196847273 Lots 23GBV681 23HBD138 23IBF254 23LBJ787

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0465-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0465-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-14

Product code LRW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)