CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
The Safe-t-fill Capillary Blood Collection System recalled by ASP Global
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-0554-2026
- 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, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 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.
Questions about this recall
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 7450 GTIN (Inner Pack): 30643351000193 UDI-DI: 10643351000199 All Lots produced from 01AUG2023 to 28FEB2025: 23H4158
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
23 other products · FDA event 97592This product is part of a recall event; the main page for the event is A clear, plastic capillary blood collection tube recalled by ASP Global.
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 recalled by ASP Global | ASP Global | Other | Nationwide |
| Device | CLASS II | The Safe-t-fill Capillary Blood Collection System recalled by ASP Global | 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 |
Other Syringes & Needles recalls
All 1,065| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care | Bayer Medical Care | Sterility | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | IV Sets with drip chambers recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |