Medline Convenience Kits Syringe Recall, 270k Units
Summary
Medline Industries LP initiated a Class II recall of 270,311 Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of 510(k) clearance. The FDA determined the cause was a component change control issue. Affected products include GU DAVINCI PACK (DYNJ909398A) and ROBOTIC PACK (DYNJ908706D) distributed nationwide in the US and internationally to Canada, Panama, and Barbados.
“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 a recall of 270,311 convenience kit units containing 10mL polycarbonate syringes after determining that design changes were made to the products without FDA 510(k) clearance. The FDA classified this as a Class II recall and identified component change control as the root cause. Affected customers were notified via email and first-class mail on February 27, 2026 and instructed to request over-labels and replace the recalled syringe component.
Healthcare providers who received these kits should verify their inventory against the listed lot numbers and product codes, request over-labels from Medline, and replace affected syringe components. The recall affects gynecological laparoscopic kit and robotic pack products distributed both domestically and internationally.
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-1885-2026 |
| Recall Event ID | 98601 |
| Product Classification | Gynecological laparoscopic kit - Product Code OHD |
| Product | Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes |
GU DAVINCI PACK - LF DYNJ909398A
ROBOTIC PACK DYNJ908706D |
| Code Information | DYNJ909398A
UDI-DI 10195327338190 (EA) 40195327338191 (CS)
LOTS 24GMH510
24HMG886
DYNJ908706D
UDI-DI 10198459017773 (EA) 40198459017774 (CS)
LOTS 24HMA783
24HMG308
24KMC651
24KMJ274
24LME931
25AME217
25BMI653 |
| 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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