Class II Recall: Medline Convenience Kits with Unapproved Syringe Design Changes Affecting 270,311 Units
Summary
Medline Industries, LP (FEI 1417592) initiated a Class II recall of Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes distributed under catalog numbers including Bariatric (DYNJ905153M/N), General Laparoscopy Pack (DYNJ81602), Laparoscopy (DYNJ905157K/L), Laparotomy Pack (DYNJ46675G), Major Lithotomy Pack (DYNJ81607), Major Plus Pack (DYNJ905160O), and Minor General Pack (DYNJ81599). The recall affects 270,311 units distributed nationwide and to Canada, Panama, and Barbados. The reason for recall is unapproved design changes to the products outside of 510(k) clearance, with FDA determining the cause to be inadequate component change control.
“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.”
What changed
Medline Industries initiated this Class II recall after FDA determined that design changes were made to 10mL polycarbonate colored syringes packaged within various convenience kits without obtaining new or amended 510(k) clearance, violating 510(k) submission requirements. The FDA-determined cause is a failure in component change control processes.\n\nHealthcare providers and facilities that received affected kits (bariatric, general laparoscopy, laparoscopy, laparotomy, major lithotomy, major plus, and minor general packs) should check their inventory against the listed catalog numbers and lot codes, request over-labels from Medline, and remove and replace any recalled syringe components. The distribution to Canada, Panama, and Barbados means international supply chain exposure may also exist for US-sourced kits.
What to do next
- 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.
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-1881-2026 |
| Recall Event ID | 98601 |
| Product Classification | laparoscopy kit - Product Code FDE |
| Product | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes |
BARIATRIC DYNJ905153M, DYNJ905153N
GENERAL LAPAROSCOPY PACK DYNJ81602
LAPAROSCOPY DYNJ905157K, DYNJ905157L
LAPAROTOMY PACK DYNJ46675G
MAJOR LITHOTOMY PACK DYNJ81607
MAJOR PLUS PACK DYNJ905160O
MINOR GENERAL PACK DYNJ81599 |
| Code Information | DYNJ905153M
UDI-DI 10195327556761 (EA) 40195327556762 (CS)
LOT 24CMG485
DYNJ905153N
UDI-DI 10198459017797 (EA) 40198459017798 (CS)
LOT 25DMC254
DYNJ81602
UDI-DI 10195327123857 (EA) 40195327123858 (CS)
LOT 24ABP080
DYNJ905157K
UDI-DI 10195327556921 (EA) 40195327556922 (CS)
LOTS 24DMF349
24EMC297
DYNJ905157L
UDI-DI 10198459017711 (EA) 40198459017712 (CS)
LOTS 24FMD083
24HMD400
24IME332
24JMA234
24KMG588
25AMA393
25AMJ541
25BMI202
25CMD909
25CMH371
DYNJ46675G
UDI-DI 10195327419066 (EA) 40195327419067 (CS)
LOT 24ABS814
DYNJ81607
UDI-DI 10195327123918 (EA) 40195327123919 (CS)
LOT 24ABP097
DYNJ905160O
UDI-DI 10198459017742 (EA) 40198459017743 (CS)
LOTS 24HMG093
24IME714
24JMI924
24LMB556
25AME613
25BMJ076
DYNJ81599
UDI-DI 10195327124021 (EA) 40195327124022 (CS)
LOT 24BBB847 |
| 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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