Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 24, 2025
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Copan Italia recalled 1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer devic… - a moderate-severity action.
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer devic… was recalled by Copan Italia in December 24, 2025. Reason: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.. Check the official notice for the remedy. Verify recall #Z-0942-2026 with the FDA Devices before acting.
The recall
Copan Italia issued this moderate-severity FDA Devices recall-Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed..
- Moderate
- severity level
- 123K units
- affected scope
- Class II
- classification
- December 24, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0942-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0942-2026) was formally reported on December 24, 2025, with the manufacturer initiating the action on October 29, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Copan Italia is listed as the recalling firm, operating out of Brescia. Federal records list the affected scope as 122,850 units US, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed. Distribution data in the federal record shows the product reached: US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
122,850 units US
Related Recalls
6
3 from same agency
Product description
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
Reason for recall
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0942-2026 |
| Date reported | December 24, 2025 |
| Date initiated | October 29, 2025 |
| Recalling firm | Copan Italia |
| Firm location | Brescia |
| Affected scope | 122,850 units US |
| Distribution | US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT |
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-0942-2026) 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.
Frequently Asked Questions
What product was recalled? ▼
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System. Recalled by Copan Italia. Units affected: 122,850 units US.
Why was this product recalled? ▼
Treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0942-2026.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: CA, CO, FL, GA, MN, MS, NH, NJ, NY, OH, PA, TN, TX, UT.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0942-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 24, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.