Medline Convenience Kit Syringe Recall, 270,311 Units, Class II

Class 2 Device Recall MEDLINE CONVENIENCE KITS

• FDA Home

• Medical Devices

- 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 | |

ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B

LAVH GRH-LF DYNJ41792G |
| Code Information | DYNJ53744B
UDI-DI 10193489761689 (EA) 40193489761680 (CS)
LOT 24ABS765

DYNJ41792G

UDI-DI 10195327547127 (EA) 40195327547128 (CS)
LOT 24ABT556 |
| 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. | |