Food, drugs, devices › Becton Dickinson & Co.

Device recall: BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 4

Q: Why was this device recalled?

FDA's record gives the reason for recall as: "The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in which case slides would require manual…"

Q: What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Q: Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution: US (Nationwide) and to countries of: Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium."

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 25 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Q: Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

FDA enforcement event 81097 · Class III · initiated 21 Sep 2018 · status Terminated · terminated 25 Apr 2019

DeviceVoluntary: Firm initiated1 product recordSparks, MD

Becton Dickinson & Co. (Sparks, MD) initiated this device recall on 21 Sep 2018; FDA lists 1 product record under event 81097, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 25 Apr 2019. Initiation: voluntary: firm initiated. Becton Dickinson & Co. has 77 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Becton Dickinson & Co., Sparks, MD.

Reason for recall

"The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in which case slides would require manual…"

Distribution

"Worldwide distribution: US (Nationwide) and to countries of: Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0081-2019	BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and…	1063	Class III	Terminated	17 Oct 2018

Context

4%of 2018 device events are Class III1,074 events that year

1product record in this eventfirm median: 1

77events on this register for the firm

Other enforcement events for Becton Dickinson & Co.

Initiated	Product (first record)	Type	Class	Records
7 Apr 2026	BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use	Device	Class II	2
23 Oct 2025	BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;	Device	Class II	1
23 Sep 2025	BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Nu	Device	Class II	6
23 Jun 2025	BD COR System Software. Model Number: 444829.	Device	Class II	1
20 May 2025	BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from cul	Device	Class II	1
12 Feb 2025	BD BBL TB Stain Kit K, Catalog (REF): 212522	Device	Class II	1
19 Dec 2024	BD PCR Cartridges used with MAX System. Model Number: 437519	Device	Class II	1
6 Nov 2024	BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitat	Device	Class II	1
31 Oct 2024	BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007	Device	Class II	13
12 Sep 2024	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory soft	Device	Class II	1

All 77 events for Becton Dickinson & Co.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrument returns to normal operating conditions when environmental temperatures are at or above 15 deg. C. This issue has no potential to cause harm to either the patient or the operator. At the lower temperature, the instrument may fail to initialize, in which case slides would require manual…"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution: US (Nationwide) and to countries of: Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 25 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.