CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
A clear, plastic capillary blood collection tube recalled by ASP Global
ASP Global is recalling A clear, plastic capillary blood collection tube, distributed nationwide in the US. The recall was initiated on 26 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0564-2026
- FDA event ID
- 97592
- Recalling firm
- ASP Global, Austell, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Sep 2025
- FDA classified
- 19 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 26 Sep 2025 | Recall initiated by company | |
| 19 Nov 2025 | Classified by FDA | +54 days |
| 26 Nov 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
Where it was distributed
Distribution US nationwide and Canada.
Stores named: Walmart
Questions about this recall
Is A clear, plastic capillary blood collection tube recalled?
Yes. ASP Global recalled A clear, plastic capillary blood collection tube on 26 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0564-2026.
Why was it recalled?
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Which lots are affected?
Model Number: 06 0402 GTIN (Inner Pack): 30643351000346 UDI-DI: 10643351000342 All Lots produced from 01AUG2020 to 28FEB2025: 22A4541, 22G4485, 22K4018, 23A4160, 23C4340, 23F4168, 23F4169, 23H4107, 23I4055, 23J4039, 24E4129, 24F4189
Where was it sold?
Distribution US nationwide and Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ASP Global
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | A clear, plastic capillary blood collection tube coated with Heparin recalled | ASP Global | Foreign Material | Nationwide |
| Device | CLASS II | The Safe-t-fill Capillary Blood Collection System is recalled | ASP Global | Other | Nationwide |
| Device | CLASS II | The Safe-t-fill Capillary Blood Collection System is recalled | ASP Global | Other | Nationwide |
| Device | CLASS II | Safe-t-fill Micro Collection Tube Extender recalled by ASP Global | ASP Global | Other | Nationwide |
| Device | CLASS II | A clear, plastic capillary blood collection tube recalled by ASP Global | ASP Global | Foreign Material | Nationwide |
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