Z-1841-2021Class II

Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit...

Name: Z-1841-2021 Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit...
Creator: Medline Industries Inc
Published: 2021-04-30
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-04-30 / Open, Classified / root cause: software

FDA source

Medline Industries Inc began a recall of Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for... on 2021-04-30. FDA classified it as Class II and gives the reason as "The devices may not meet the minimum required sterility assurance level". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1841-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-30
Posted: 2021-06-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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.
Product code: LRO General Surgery Tray
Reason for recall: The devices may not meet the minimum required sterility assurance level.
Root cause tag: software
FDA root cause: Software change control
Action: 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.
Quantity in commerce: 36/3-kit cases (108 kits)
Distribution: US Distribution to state of: WI.
Product codes and lots: GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1841-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1841-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-16	2021-06-09

Product code LRO

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)