Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2206-2023

May 12, 2023

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 92412
Status
Ongoing
Classification
Class II
Quantity
189,221 scissors
Official record key
device-enforcement:Z-2206-2023

Official wording

Reason: The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.

Code information: 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.

Distribution pattern: US Nationwide distribution. There was government distribution but no military or foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.