CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
The Safe-t-fill Capillary Blood Collection System is recalled
ASP Global is recalling The Safe-t-fill Capillary Blood Collection System is a collection device used to draw, 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-0544-2026
- 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
- Other Reasons
- 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.
Product as listed by the FDA
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Where it was distributed
Distribution US nationwide and Canada.
Stores named: Walmart
Questions about this recall
Is The Safe-t-fill Capillary Blood Collection System is a collection device used to draw recalled?
Yes. ASP Global recalled The Safe-t-fill Capillary Blood Collection System is a collection device used to draw on 26 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0544-2026.
Why was it recalled?
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Which lots are affected?
Model Number: 07 6101 GTIN (Inner Pack): 10643351000083 UDI-DI: 10643351000083 All Lots produced from 01AUG2023 to 28FEB2025: 23H4112, 23I4019, 23J4032, 24B4189, 24H4122, 24I4319, 24J4236, 24L4003
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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