FDA Devices recall · Reported October 17, 2018
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.
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 temperatu…
Becton Dickinson & Co. recalled BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 49… - a low-severity action.
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 49… was recalled by Becton Dickinson & Co. in October 17, 2018. Reason: The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrume…. Check the official notice for the remedy. Verify recall #Z-0081-2019 with the FDA Devices before acting.
The recall
Becton Dickinson & Co. issued this low-severity FDA Devices recall-The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. The instrume….
- Low
- severity level
- 1K units
- affected scope
- Class III
- classification
- October 17, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0081-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
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 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0081-2019 |
| Date reported | October 17, 2018 |
| Date initiated | September 21, 2018 |
| Recalling firm | Becton Dickinson & Co. |
| Firm location | Sparks, MD |
| Affected scope | 1063 |
| Distribution | Worldwide distribution: US (Nationwide) and to countries of: Korea, Australia, Japan, Malaysia, Canada, Brazil, and Belgium. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0081-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026