Becton Dickinson Recalls Phoenix AP AST Indicator Bags Due to Test Aborts
Becton Dickinson is recalling Phoenix AP AST Indicator Bags because certain lots cause increased test aborts. The products were distributed to 40 US states and 33 foreign countries.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a functional defect (test aborts) rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for low-risk issues or voluntary precautionary measures.
Plain-English summary
Becton Dickinson & Co. is recalling Phoenix AP AST Indicator Bags, Catalog Number 246006. The recall involves 62,880 units across 20 specific batch numbers. The agency has classified this as a Class II recall.
The recall was initiated because panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts. This issue affects the reliability of the diagnostic results rather than posing a direct physical injury risk to patients.
The affected products were distributed to 40 US states, including Alabama, California, Florida, and Texas, as well as 33 foreign countries, including Canada, Japan, and Brazil. Users of these products should stop using the affected lots and contact Becton Dickinson for further instructions or replacement.
The recalled product
- Product
- Phoenix AP AST Indicator Bag, Catalog Number 246006
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 62,880
Distribution
Part of a larger recall action
This product is one of 3 recalled by Becton Dickinson & Co. 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 & Co.
See all →- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
- HighAutomated microbiology systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighBlood culture systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- LowBecton Dickinson Recalls PhoenixSpec AP Calibrator Due to Labeling Error
FDA (Devices) · 2016-11-02
- ModerateBecton Dickinson Recalls BD Max Vaginal Panel Kits Due to Seal Defects
FDA (Devices) · 2019-08-28
- LowBecton Dickinson Recalls PhoenixSpec Calibrator Kits Due to Labeling Error
FDA (Devices) · 2016-11-02
- ModerateBD Max Check-Points CPO IVD Kit Recalled for Improperly Sealed Foil Bags
FDA (Devices) · 2019-08-28
- LowBD Phoenix AP Instrument Recalled for Potential Robot Arm Movement
FDA (Devices) · 2017-12-13
- HighBD Phoenix PMIC-108 Panels Recalled for False Susceptibility Test Results
FDA (Devices) · 2012-12-26