Z-2206-2023Class II

Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

Name: Z-2206-2023 Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-05-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-12 / Open, Classified / root cause: packaging

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 on 2023-05-12. FDA classified it as Class II and gives the reason as "The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising 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-2206-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-12
Posted: 2023-07-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000
Product code: HRR Scissors, Orthopedic, Surgical
Reason for recall: The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters dated 5/12/2023 via first class mail and email on 5/12/2023. The letter explained the reason for recall and provided the required actions. The actions were to immediately check their inventory for the affected item number and lot numbers listed on the recalling firm's recall portal and destroy the products. A website link is provided for completing the response form and for obtaining the specific item and lot numbers affected. Once the response form is submitted, the consignee account will be credited. Distributors are instructed to notify the customers of the recall who have received the affected product and the customer is to document the destruction of their product. The distributor is to include the customer product quantities in their response form.
Quantity in commerce: 189,221 scissors
Distribution: US Nationwide distribution. There was government distribution but no military or foreign distribution.
Product codes and lots: Lot numbers and UDI numbers: 23BBI031, 01100801968242291023BBI031; 23BBK353, 01100801968242291023BBK353; 23BBP830, 01100801968242291023BBP830; 23BBQ676, 01100801968242291023BBQ676; 23BBR546, 01100801968242291023BBR546; 23CBH009, 01100801968242291023CBH009; 23CBL930, 01100801968242291023CBL930; 23CBP165, 01100801968242291023CBP165; 23BBS369, 01100801968242291023BBS369; 23BBT718, 01100801968242291023BBT718; 23CBV064, 01100801968242291023CBV064; 23CBW834, 01100801968242291023CBW834; 23CBV222, 01100801968242291023CBV222; 23CBW020, 01100801968242291023CBW020; and 23CBQ190, 01100801968242291023CBQ190.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2206-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2206-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-20

Product code HRR

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)