Medline IV Catheter Kits Recalled for Needle Retraction Failure
Medline is recalling specific convenience kits containing BD Insyte Autoguard IV catheters because the needle may be slow to retract or fail to retract during insertion, posing a potential injury risk.
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 medical device recall for a product with a potential for harm (needle retraction failure during insertion), with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at the High level.
Plain-English summary
Medline Industries, LP is recalling Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters (22 GA x 1.00 IN), labeled as RETINAL PACK-LF, REF DYNJ0151148B. The recall was initiated because the needle within the catheter may be slow to retract or may fail to retract completely during insertion.
The affected kits were distributed nationwide to healthcare facilities and distributors in California, Indiana, Kentucky, Michigan, Texas, and Washington. The recalled product is identified by Lot Number 24LDA980 and UDI codes 10889942050819 (individual unit) and 40889942050810 (case). Approximately 80 units were distributed.
A needle that fails to retract or retracts slowly during catheter insertion poses a safety risk, as the exposed or partially exposed needle tip could result in needle-stick injury or other harm to patients or healthcare workers during the insertion procedure. This is a Class II medical device recall issued by the FDA.
The recalled product
- Product
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — IV Catheter
- Hazard
- needle-retraction-failure
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 (3)
- 1) REF DYNJ0151148B: UDI/DI 10889942050819 (each)
- 40889942050810 (case)
- Lot Number 24LDA980
Distribution
Distributed nationwide across the United States.
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