Medline Convenience Kits Syringes Recall, 270k Units
Summary
FDA has classified a Class II recall of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes. Medline Industries initiated the recall on February 27, 2026 after determining that unapproved design changes were made to the products outside of 510(k) clearance. Approximately 270,311 units were distributed US nationwide and internationally to Canada, Panama, and Barbados.
What changed
Medline Industries initiated a Class II recall for Medline Convenience Kits (BIOPSY PACK, BIOPSY/DRAINAGE TRAY-LF, and W LINQ PACK) containing select SKUs of 10mL Polycarbonate Colored Syringes. The recall was initiated after the firm determined that unapproved design changes were made to the products outside of 510(k) clearance. FDA classified the cause as a component change control issue.\n\nHealthcare providers and facilities that received these kits should check their inventory against the listed lot numbers and UDI-DI codes. The firm is notifying customers via email and first-class mail with instructions to request over-labels for affected kits, directing consignees to remove the recalled component and replace it with product from their supply. Facilities should verify whether their supply chain includes any of the affected SKUs: DYNJ38587A, DYNJ38587B, DYNJ30078D, and DYNJ59108B.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 2 Device Recall MEDLINE CONVENIENCE KITS
- Databases
| 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards |
| CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | |
| New Search | ) |
| | Class 2 Device Recall MEDLINE CONVENIENCE KITS | |
| Date Initiated by Firm | February 27, 2026 |
|---|---|
| Date Posted | April 17, 2026 |
| Recall Status | Open , Classified |
| Recall Number | Z-1879-2026 |
| Recall Event ID | 98601 |
| Product Classification | CT biopsy tray - Product Code OFG |
| Product | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes |
BIOPSY PACK DYNJ38587A, DYNJ38587B
BIOPSY/DRAINAGE TRAY-LF DYNJ30078D
W LINQ PACK DYNJ59108B |
| Code Information | DYNJ38587A
UDI-DI 10193489754070 (EA) 40193489754071 (CS)
LOTS 20BBF696
20EBH917
20FBW435
20HBM667
20JBF107
20KBW292
20LBS930
21EBB195
21FBR610
21GBS936
21GBS940
21JBU912
21KBP999
22ABX182
22EBI922
22GBZ788
22JBL031
23BBN160
DYNJ38587B
UDI-DI 10195327397326 (EA) 40195327397327 (CS)
LOTS 23DBP789
23FBM124
23HBW639
23JBN841
24ABG236
24CBM867
24FME120
24JMD066
24LME187
DYNJ30078D
UDI-DI 10889942138647 (EA) 40889942138648 (CS)
LOTS 23CBK546
23FBQ481
23IBQ435
23JBR634
23LBG856
24ABE287
24BBS264
24EBQ336
24GBJ987
24JBO830
DYNJ59108B
UDI-DI 10198459138461 (EA) 40198459138462 (CS)
LOT 24JBP861 |
| FEI Number | 1417592 |
| Recalling Firm/
Manufacturer | Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753 |
| For Additional Information Contact | Haley Barclay
800-633-5463 |
| Manufacturer Reason
for Recall | Unapproved design changes to the products outside of the 510(k) clearance. |
| FDA Determined
Cause | Component change control |
| Action | On February 27, 2026, the firm began notifying customers via email and first-class mail.
Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply. |
| Quantity in Commerce | 270,311 total |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados. |
| Total Product Life Cycle | TPLC Device Report |
| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |
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