Z-2595-2023Class II

Medline Sterile Iris Scissors Cvd/std, Ref Dynj04049

Name: Z-2595-2023 Medline Sterile Iris Scissors Cvd/std, Ref Dynj04049
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-08-03
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-08-03 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049 on 2023-08-03. FDA classified it as Class II and gives the reason as "4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large...". 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-2595-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-03
Posted: 2023-09-18
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Sterile Iris Scissors Cvd/std, Ref Dynj04049
Product code: JOK Scissors, Medical, Disposable
Reason for recall: 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Medline Industries issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem with the device, the potential hazard, and requested the following: Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. Distributors or those who resold or transferred the product were directed to notify their customers and have them destroy any affected product. If you have any questions, please contact the Recall Department at 866-359-1704.
Quantity in commerce: 324,451 devices
Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore
Product codes and lots: UDI/DI 10080196847273, all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2595-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2595-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18

Product code JOK

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)