Procedure packs recallZ-1646-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Apr 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The kits were damaged by water.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1646-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 21, 2023
- Posted by the FDA
- May 26, 2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 342 packs (114 packs/product)
- Product code
- OJH
- Distribution
- Distribution was made to California. There was no foreign/government/military distribution.
Product description
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.
Code information (models, lots, serial numbers)
(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.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ64242BMedline Industries, Inc. · Orthopedic tray1 recall9 reports
- Medline Industries, Inc. DYNJ64250AMedline Industries, Inc. · Orthopedic tray1 recall0 reports
- Medline Industries, Inc. DYNJ64253BMedline Industries, Inc. · Orthopedic tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page