Medline IV Catheters Recalled for Needle Retraction Failure
Medline Industries is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters because the needle may be slow to retract or fail to retract during catheter insertion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a potential safety hazard (needle retraction failure during medical device use). The source text does not report any injuries or adverse events. Per the rubric, risk-of-harm medical devices where injury has not yet been reported score as High (3).
Plain-English summary
Medline Industries, LP is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. The catheters are affected across six specific product references and lot numbers. During insertion of the catheter, the needle may be slow to retract or fail to retract, creating a potential safety hazard.
The recalled kits have been distributed nationwide in Indiana, Kentucky, California, Michigan, Texas, and Washington. A total of 186 units have been identified in this recall. The specific product references affected are: CC DRAWER 4 IV CIRCULATION (REF ACC010254B, Lot 24LDA269); CC ADULT DRAWER 2 (REF ACC010256, Lot 24LDA106); PEDI EMERGENCY TRAY-BLUE (REF ACC010316A, Lot 24LDA823); ADULT DRAWER 4 (REF ACC010389C, Lot 24LDB092); DRAWER 4 - SUMMIT (REF ACC010627, Lot 24LDA268); and DRAWER 3 (REF ACC010898, Lot 24LDA260).
Healthcare facilities and providers who have received these kits should identify and quarantine the affected products by lot number and discontinue their use. Contact Medline Industries, LP for further instructions regarding return or replacement of the recalled catheters.
The recalled product
- Product
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — IV Catheters
- Hazard
- needle-retraction-failure
- injury-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 1) REF ACC010254B: UDI/DI 10193489651683 (each)
- 40193489651684 (case)
- Lot Number: 24LDA269
- 2) REF ACC010256: UDI/DI 10884389559529 (each)
- 40884389559520 (case)
- Lot Number: 24LDA106
- 3) REF ACC010316A: UDI/DI 10889942831746 (each)
- 40889942831747 (case)
- Lot Number: 24LDA823
- 4) REF ACC010389C: UDI/DI 10193489472493 (each)
- 40193489472494 (case)
- Lot Number: 24LDB092
- 5) REF ACC010627: UDI/DI 10195327226589 (each)
- 40195327226580 (case)
- Lot Number: 24LDA268
- 6) REF ACC010898: UDI/DI 10198459192074 (each)
- 40198459192075 (case)
- Lot Number: 24LDA260.
Distribution
Distributed nationwide across the United States.
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