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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81952

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 20, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton Dickinson & Co.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Phoenix AST-s Indicator, Catalog Number 246009

Z-0933-2019
Recall number
Z-0933-2019
Initiated
December 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
62880 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

Code information

Batch Numbers 8298797 8254819 8254817 8247760 8247750 8206530 8194853 8156642 8156638 8131658 8103973 8094595 8023542 7354942 7300813

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam

device · product 2 of 3

Phoenix AST Indicator, Catalog Number 246004

Z-0934-2019
Recall number
Z-0934-2019
Initiated
December 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
62880 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

Code information

Batch Numbers 8150994 8143513 8114664 8103968 8101893 8094599 8088904 8254800 8247722 8239891 8236927 8236686 8159672 8156625 8150957 8150525

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam

device · product 3 of 3

Phoenix AP AST Indicator Bag, Catalog Number 246006

Z-0935-2019
Recall number
Z-0935-2019
Initiated
December 20, 2018
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
62880 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

Code information

Batch Numbers 8234684 8234533 8225579 8225578 8218607 8218605 8213696 8213635 8213633 8208581 8208579 8206585 8190531 8190530 8170557 8234505 8170562 8159691 8150670 8150669

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, India, Indonesia, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Pakistan, Panama, Peru, Philippines, San Salvador, Singapore, Sri Lanka, Thailand, Taiwan, Uruguay, Vietnam

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