1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case… recallZ-0533-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Oct 15, 2024
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
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
FDA root cause category: Mixed-up of materials/components
What the company is doing
The recalling firm issued letters on and dated 10/15/2024 via email and first-class mail explaining the issue, potential risk, and informing the consignee stickers are to be provided upon request to be placed onto the Medline pack instructing that the affected component is to be removed and replaced with an item in inventory. Required actions were included which were to (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) Use the link and information in the letter to complete the response form. List the quantity of affected product in inventory on the form. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory with instructions for the consignee staff to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight; (4) If the consignee is a distributor or has resold or transferred this product to another company or individual, the consignee is to notify them of the recall communication.
Recall details
- Recall number
- Z-0533-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 15, 2024
- Posted by the FDA
- Nov 25, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 360 kits
- Product code
- LRO
- Distribution
- US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Product description
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Code information (models, lots, serial numbers)
(1) REF DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ904220FMedline Industries, Inc. · General surgery tray3 recalls0 reports
- Medline Industries, Inc. DYNJ59194AMedline Industries, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95638).
- Z-0532-2025 · Open, Classified(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
- Z-0534-2025 · Open, ClassifiedMedline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
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.
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