Device recall: CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Class II FDA enforcement event 93216. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Products were stored outside of labeled temperature requirements.
Class II, in the words of FDA
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
The recalling firm started this device recall on 4 Oct 2023. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Chesapeake, VA. FDA put the recall in Class II. FDA event 93216 has 10 product records. The first FDA enforcement report date is 15 Nov 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.
Recalling firm
The name is withheld, Chesapeake, VA.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0261-2024 | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0262-2024 | AT HOME MARIJUANA TEST STRIP, SKU 900752 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0263-2024 | FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0264-2024 | VERIQUICK PREGNANCY TEST 1CT, SKU 901260 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0265-2024 | DENTEMP ONE STEP .077OZ, SKU 902139 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0266-2024 | FIRST RESPONSE 2 CT, SKU 902343 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0267-2024 | GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0268-2024 | ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0269-2024 | MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
| Z-0270-2024 | ORAL B MOUTH SORE RINSE 237ML, SKU 999087 | 329,044 total units | Class II | Ongoing | 15 Nov 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 10
Official channels
- FDA enforcement report Z-0261-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 93216. https://recallregister.com/fda/ii/93216/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.
- What quantity of product is in FDA event 93216?
- The event has 10 product records. The first record gives this quantity:
329,044 total units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.