Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2112-2013·Announced 2013-09-04

Becton Dickinson PrepStain Tecan US-II Recall for Incorrect Rack Setting

Becton Dickinson is recalling 890 PrepStain Tecan US-II instruments because a rack setting was incorrectly entered during routine maintenance.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source describes a configuration error during maintenance without reporting specific injuries or illnesses, fitting the Moderate severity criteria for a precautionary or minor defect recall.

Plain-English summary

Becton Dickinson & Co. is recalling 890 units of the PrepStain Tecan US-II system. This device is used for the screening and detection of cervical cancer. The recall involves catalog numbers 799-14000-00 (490100) and 799-14000-00R (490407).

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 agency has classified this as a Class II recall.

The affected units were distributed nationwide in the United States, in Puerto Rico, and in Canada. Users of these devices should contact Becton Dickinson & Co. for further instructions on how to proceed.

The recalled product

Product: PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
Manufacturer: Becton Dickinson & Co.
Category: Medical Device — Cervical Cancer Screening
Hazard: misconfiguration
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 (1)

Catalog Numbers - 799-14000-00 (490100) and 799-14000-00R (490407)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Becton Dickinson & Co.

See all →

Moderate
BD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
Moderate
BD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
Moderate
Laboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
High
Automated microbiology systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
High
Blood culture systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29

Same hazard · misconfiguration