Medline Convenience Kits Recall - 270,311 Units Due to Unapproved 510(k) Changes
Summary
FDA classified a Class II recall of Medline Convenience Kits (270,311 units) containing 10mL polycarbonate colored syringes. The recall was initiated because the firm made unapproved design changes outside of 510(k) clearance. Affected SKUs are EYE PACK (DYNJ35056A) and HEART CATH PACK (DYNJ69318A) distributed nationwide in the US and to Canada, Panama, and Barbados. The firm began notifying customers on February 27, 2026 via email and first-class mail, instructing them to request over-labels for affected kits.
“Unapproved design changes to the products outside of the 510(k) clearance.”
What changed
FDA classified a Class II recall of Medline Convenience Kits containing 10mL polycarbonate colored syringes (270,311 units) on April 17, 2026. The firm initiated the recall on February 27, 2026 after determining that design changes were made to the products without obtaining 510(k) clearance. Multiple lot numbers are affected across two product codes: EYE PACK (DYNJ35056A) and HEART CATH PACK (DYNJ69318A).
Healthcare providers and facilities that have received these convenience kits should contact Medline at 800-633-5463 to request over-labels. The over-labels instruct users to remove the recalled syringe component and replace it with product from their supply. Medical device manufacturers should also review their own component change control procedures to ensure any modifications to cleared devices follow proper 510(k) modification protocols.
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-1886-2026 |
| Recall Event ID | 98601 |
| Product Classification | Eye tray - Product Code OJK |
| Product | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes |
EYE PACK DYNJ35056A
HEART CATH PACK DYNJ69318A |
| Code Information | DYNJ35056A
UDI-DI 10889942227563 (EA) 40889942227564 (CS)
LOT 24ABN639
DYNJ69318A
UDI-DI 10195327370756 (EA) 40195327370757 (CS)
LOTS 23DMD456
23EMB847
23HMB969
23IMC364
23JME011
23JMI841
23LMC384
24BMD333
24CMB768
24CMJ586
24EMJ527
24GMD970
24JMB408
24JMI594
24KMC774 |
| 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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