Tubes, Vials, Systems, Serum Separators, Blood Collection
FDA adverse event reports and recall history for tubes, vials, systems, serum separators, blood collection (product code JKA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 48,114
- Deaths
- 3
- Injuries
- 1,270
- Malfunctions
- 46,545
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-15Open, ClassifiedUnder Investigation by firm
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
- 2025-11-19Open, ClassifiedProcess change control
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.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-19Open, ClassifiedProcess change control
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-19Open, ClassifiedProcess change control
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-19Open, ClassifiedProcess change control
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-19Open, ClassifiedProcess change control
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-19Open, ClassifiedProcess change control
AFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-19Open, ClassifiedProcess change control
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-19Open, ClassifiedProcess change control
SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7250 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
- 2025-11-19Open, ClassifiedProcess change control
SAFE-T-FILL Micro Capillary Blood Collection, 300 L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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