BD Insyte Autoguard IV Catheter Needles May Fail to Retract Properly
BD Insyte Autoguard BC IV catheters may have needles that fail to retract properly, potentially causing contaminated needlestick injuries, blood leakage, and repeated insertion attempts.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with no reported illnesses or injuries. The hazard involves potential contaminated needlestick injury and blood exposure if the needle fails to retract. Per the rubric, this qualifies as a risk-of-harm medical device without reported injury, yielding a High (3) severity score.
Plain-English summary
The FDA has recalled BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology (20GA X 1.00in, REF: 382533) from Becton Dickinson Infusion Therapy Systems Inc. A total of 528,000 units with Lot 3166524 (Expiration Date: May 31, 2026) are affected.
These catheters may have needles that do not retract properly into the barrel. The needle's failure to retract could result in contaminated needlestick injuries, blood leaking from the insertion site or catheter, and the need for repeat catheter insertion attempts if the device is inadvertently removed during insertion.
The affected catheters were distributed nationwide to healthcare facilities and providers in California, North Carolina, Michigan, Washington, Colorado, Florida, New Jersey, New Mexico, Illinois, Kentucky, Tennessee, Ohio, Texas, Indiana, Louisiana, Iowa, Mississippi, Missouri, Nebraska, Maryland, New York, Pennsylvania, Georgia, Virginia, Maine, South Carolina, Rhode Island, Massachusetts, and Puerto Rico.
Healthcare providers should stop using the affected lot and contact Becton Dickinson or the FDA with questions about alternatives. Patients who received this catheter should inform their healthcare provider of the potential risk.
The recalled product
- Product
- BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
- Manufacturer
- Becton Dickinson Infusion Therapy Systems Inc.
- Affected units
- 528,000
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)
- UDI-DI: 00382903825332
- Lot: 3166524
- Expiration: 2026/05/31
Distribution
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Same manufacturer · Becton Dickinson Infusion Therapy Systems Inc.
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