BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Issues
Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the failure to meet sterility assurance levels in medical devices poses a significant risk of infection, meeting the criteria for a Severe rating.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets, Catalog 367344. The recall is due to the products not meeting the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
The affected products were distributed in the United States (Nationwide), Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland, and Lithuania. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers should stop using the affected blood collection sets and contact Becton Dickinson & Company for further instructions or a replacement.
The recalled product
- Product
- BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
- Manufacturer
- Becton Dickinson & Company
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Company
See all →- SevereBD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
- SevereBD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
- SevereBD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- HighBD Vacutainer Push Button Blood Collection Set Recalled for Barrel Separation
FDA (Devices) · 2016-09-07
- HighBD Vacutainer Push Button Blood Collection Set Recall for Barrel Separation
FDA (Devices) · 2016-12-21
- ModerateBD Vacutainer Blood Collection Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2017-11-15
- HighBD Vacutainer Citrate Blood Collection Tubes Recalled for Test Errors
FDA (Devices) · 2013-02-06
- HighBD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Stopper Defect
FDA (Devices) · 2015-12-30
- HighBD Vacutainer Blood Collection Tubes Recalled for Stopper Pullout Risk
FDA (Devices) · 2017-04-12