BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station
Medical device recall Z-0081-2019. Published in FDA’s Enforcement Report on Oct 17, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 17, 2018. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1063 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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 screening. Therefore, no slides are screened by the device and no results can be released in error. The instrument labeling has been revised to indicate an operating temperature lower limit of 18 deg. C and operating humidity of 20 to 80% relative humidity.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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 their usual precursor conditions.
1063, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Nos. FP0749 139335 141372 BD0507 BD0508 FP0826 138739 156312 BD0513 FP0060R 159337 159339 159348 FP0705R FPGS-RSBD0089 FPGS-RSBD0098 FP0804 148277 FP0284R BD0509 BD0511 BD0512 FP0549C FP0009R FP0013R FP0065R FP0067R FP0172R FP0220R…
Every code shown here, 1,998 characters
Serial Nos. FP0749 139335 141372 BD0507 BD0508 FP0826 138739 156312 BD0513 FP0060R 159337 159339 159348 FP0705R FPGS-RSBD0089 FPGS-RSBD0098 FP0804 148277 FP0284R BD0509 BD0511 BD0512 FP0549C FP0009R FP0013R FP0065R FP0067R FP0172R FP0220R FP0345 FP0345R FP0446 FP0446R FP0447 FP0447R FP0448R FP0494 FP0723 133215 133219 128928 127632 128051 FP0049R FP0124R 128045 128061 128914 128924 128936 145182 FPGS-RS143333 FPGS-RS143339 FPGS-RS143346 FPGS-RS143347 FPGS-RS143352 FPGS-RS143358 FPGS-RS143359 FPGS-RS143360 FPGSRS143363 FPGS-RS143371 FP0055R FP0264R FP0509R 133206 133212 155447 FP0262R FP0541R 144503 144985 145007 145193 145824 148133 148275 148281 148285 153934 155422 155428 155437 156314 159688 BD0447 FPGS-RS139336 FPGS-RS139337 FPGS-RS139338 FPGS-RS141375 FPGS-RS142653 FPGS-SVR142152 GS-RSBD0251 FP0107R FP0176R FP0472R FP0477R FP0512R 143354 144835 144853 144861 145315 145842 158332 FPGS-RS161528 FPGS-RSBD0281 FPGS-RSBD0293 FP0041R FP0497R 155434 155444 157881 157883 157886 157887 FPGS-RS-BD0179 FP0311R FP0543R 158925 FP0048R 159683 BD0470 BD0482 FPGSRS-BD0039 FPGSRS-BD0048 FP0484R FP0822 142646 142648 143368 144009 144860 144995 158917 BD0450 FP0034R FP0741 FP0747 128919R 133204 134943 134947 FP0811 FP0044R FP0485R 145307 145311 145500 155421 155421 156313 FP0096R 136209 136627 136631 136643 136646 136648 141914 145202 148269 148270 148284 148286 152298 FP0075R FP0492R FP0505R 144500 145184 145504 145822 FP0083R FPGS-RS160653 FPGS-RS160654 FPGSRS160661 FP0153R 142687 142691 143362 143365 143973 143997 144010 144499 148291 FP0091R FP0152R 143338 144025 FP0538R FP0464R 136211 161662 161667 BD0351 FP0735 159674 BD0303 BD0361 FPGS-RS139346 FP0713 713 158918 158923 158929 FP0337R BD0331 BD0504 BD0505 BD0506 BD0525 FPGS-RS138729 FPGS-RS138744 FP0825 148293 141896 144533 FP0108R FP0744 FP0809 FP0823 FP0302R BD0434 FP0340R FP0818 FP0467R FP0476R 143344 143377 144834 145183 145185 145191 145201 145203 145823 148127 148140 148146 157882 158325 159675 BD0469 BD0472 BD0473…
FDA’s list runs to 9,466 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution: US (Nationwide) and to countries of: Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 21, 2018.
- FDA classified it on Oct 5, 2018.
- FDA’s Enforcement Report published it on Oct 17, 2018.
- FDA terminated it on Apr 25, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Becton Dickinson & Co., of Sparks, MD.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 9,466 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.