Medline Tissue Recovery Instrument Set, Reorder… recallZ-1841-2021 · Medline Industries Inc · initiated Apr 30, 2021
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 Inc 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 devices may not meet the minimum required sterility assurance level.
FDA root cause category: Software change control
What the company is doing
The recalling firm, Medline Industries, Inc., issued an "IMMEDIATE ACTION REQUIRED RECALL" letter dated and emailed on 4/30/2021. The letter described the product, the reason for recall and actions to be taken. The consignees were instructed to immediately check their inventory for the affected product, complete and submit response form online to: Website link: https://recalls.medline.com; Recall Reference #: R-21-073; Recall Code: R5A2C566 , and quarantine it for subsequent return. 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. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. If you have any questions, please contact the Recall Department at 866-359-1704.
Recall details
- Recall number
- Z-1841-2021
- Status
- Open, Classified
- Initiated by the company
- Apr 30, 2021
- Recalling firm
- Medline Industries Inc
- Quantity
- 36/3-kit cases (108 kits)
- Product code
- LRO
- Distribution
- US Distribution to state of: WI.
Product description
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
Code information (models, lots, serial numbers)
GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ64347AMedline Industries, Inc. · General surgery tray1 recall1 report
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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