Z-0725-2025Class II

KIT,SPINE LH Convenience kit, SKU DYNJ906448A

Name: Z-0725-2025 KIT,SPINE LH Convenience kit, SKU DYNJ906448A
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2024-11-06
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-11-06 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of KIT,SPINE LH Convenience kit, SKU DYNJ906448A on 2024-11-06. FDA classified it as Class II and gives the reason as "Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0725-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-06
Posted: 2024-12-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Product code: OHD Gynecological Laparoscopic Kit
Reason for recall: Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 11/7/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-209-FGX1 Recall Code: Recall Code 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
Quantity in commerce: 160 kits
Distribution: US Nationwide. Canada.
Product codes and lots: UDI-DI: 10193489408508(each), 40193489408509(case); Lot Number: 21EBG271 21CBS664 20LBO883 20WBE707

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0725-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0717-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0718-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0719-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0720-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0721-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0722-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0723-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0724-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0725-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0726-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20

Product code OHD

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)