Z-1646-2023Class II

Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack...

Name: Z-1646-2023 Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-04-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-04-21 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper... on 2023-04-21. FDA classified it as Class II and gives the reason as "The kits were damaged by water". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1646-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-21
Posted: 2023-05-26
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.
Product code: OJH Orthopedic Tray
Reason for recall: The kits were damaged by water.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued the recall letter dated 4/21/2023 via email on 4/21/2023. The letter informed the customer the packs were exposed to water, potentially affecting the sterility of the item, and that they should be destroyed for credit. The consignee was requested to immediately check their stock for the affected item number and the lot numbers listed on the recall portal. A link was provided to access the response form to list the quantity of affected product in inventory. Upon completion of the form, the consignee was to destroy the affected product. If the consignee is a distributor or have resold or transferred the product to another company or individual, they were to notify them of this recall communication and have the customer document and destroy any affected product.
Quantity in commerce: 342 packs (114 packs/product)
Distribution: Distribution was made to California. There was no foreign/government/military distribution.
Product codes and lots: (1) Arthroscopy Pack - Lot #22HMD098, Exp. 2024-04-30, UDI/DI (01)10193489956405; (2) Shoulder Pack -Lot #22JMA673, Exp. 2024-01-31, GTIN (01)10193489429817; and (3) Upper Extremity Pack - Lot #HMF900, Exp. 2024-01-31, UDI/DI (01)10193489968453.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1646-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1646-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-05-26

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)