FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list ASP Global with 89 device recalls and 1 warning letter. The most recent is a warning letter dated Dec 9, 2025: Warning letter: MDR reporting, Design controls, Supplier controls.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 9, 2025 | Warning letter: MDR reporting, Design controls, Supplier controlsCDRH | Warning letters |
| Sep 26, 2025 | 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,Class II · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | Device recalls |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 71Class II · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | Device recalls |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product DescriClass II · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | Device recalls |
| Sep 26, 2025 | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clearClass II · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | Device recalls |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product DescriptiClass II · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | Device recalls |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: Class II · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | Device recalls |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product DescriptiClass II · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | Device recalls |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product DescripClass II · Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
