Becton Dickinson PrepStain AG System Recall for Incorrect Rack Setting
Becton Dickinson is recalling 890 PrepStain AG systems because a rack setting was incorrectly entered during routine maintenance.
What this means for you
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, which typically indicates a temporary or medically reversible adverse health consequence. The issue is a configuration error during maintenance rather than a manufacturing defect causing direct physical harm, fitting the Moderate severity criteria for low-risk operational errors.
Plain-English summary
Becton Dickinson & Co. is recalling 890 units of the PrepStain AG system, which is used for the screening and detection of cervical cancer. The recall involves catalog numbers 05CR00021, 05CR00021R, 05CR00022, 05CR00022R, 05CR00023, and 05CR00023R.
The recall was initiated because the PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine preventive maintenance visit by a BD Field Service Representative. The affected products were distributed nationwide in the United States, in Puerto Rico, and in Canada.
Healthcare facilities and users of the PrepStain AG system should contact Becton Dickinson & Co. for further instructions regarding the recall and corrective actions.
The recalled product
- Product
- PrepStain AG. For use in the screening and detection of cervical cancer.
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 890
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 (6)
- Catalog Numbers - 05CR00021
- 05CR00021R
- 05CR00022
- 05CR00022R
- 05CR00023
- 05CR00023R
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 · mis configuration
See all →- ModerateIceSeed 1.5 CX S Cryoablation Needle Programmed with Incorrect Settings
FDA (Devices) · 2025-05-07
- HighLab analyzer incorrectly configured for complex testing at waived facilities
FDA (Devices) · 2024-09-04
- HighTerumo Capiox FX25 Advance Oxygenator Recall for Configuration Error
FDA (Devices) · 2020-12-23
- HighPhilips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue
FDA (Devices) · 2016-10-26
- HighPhilips IntelliVue MX40 Patient Monitor Recalled for ECG Alarm Configuration Issue
FDA (Devices) · 2016-10-26