Z-1029-2023Class II

Non-sterile procedural trays labeled as CRANI, 2 per case

Name: Z-1029-2023 Non-sterile procedural trays labeled as CRANI, 2 per case
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-11-17
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-11-17 / Open, Classified / root cause: design

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Non-sterile procedural trays labeled as CRANI, 2 per case on 2022-11-17. FDA classified it as Class II and gives the reason as "Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1029-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-17
Posted: 2023-01-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Non-sterile procedural trays labeled as CRANI, 2 per case
Product code: OJH Orthopedic Tray
Reason for recall: Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Root cause tag: design
FDA root cause: Device Design
Action: Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form.
Quantity in commerce: 12 cases (24 units)
Distribution: US Nationwide distribution in the states of AR, MD, WA, WI.
Product codes and lots: Item Number: DYNJ900413P, UDI/GTIN Case: 40195327031665, UDI/GTIN Each: 40195327031665, Lot Number: 22JDB689

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1029-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1029-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1030-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1031-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1032-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1033-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1034-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27
Z-1035-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-27

Product code OJH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)