Hazard

Unvalidated Process recalls

43 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 43
Critical: 0
Severe: 0
Most recent: 2025-11-26

Of the 43 unvalidated process recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unvalidated process recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 43

ModerateFDA (Devices)·Z-0547-2026·2025-11-26
Clot activator microtubes recalled over an inadequate quality system
ASP Global is recalling 27,950 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator, over an inadequate quality system.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0554-2026·2025-11-26
Amber clot activator microtubes recalled over an inadequate quality system
ASP Global is recalling 1,500 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator in an amber microtube, over an inadequate quality system.
Product
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 o
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0558-2026·2025-11-26
Large volume capillary tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 352,750 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with balanced heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0557-2026·2025-11-26
Blood gas capillary tubes recalled over an inadequate quality system
ASP Global is recalling 397,000 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres, because they were manufactured under an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0546-2026·2025-11-26
Serum separator microtubes recalled over unvalidated manufacturing processes
ASP Global is recalling 64,850 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator and serum separator gel, over an inadequate quality system.
Product
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 f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0551-2026·2025-11-26
Lithium heparin capillary tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 103,200 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin, over an inadequate quality system.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0565-2026·2025-11-26
Capillary magnetic rings recalled over unvalidated manufacturing processes
ASP Global is recalling 16,920 SAFE-T-FILL magnetic rings for blood gas capillaries over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0555-2026·2025-11-26
Microhematocrit capillary tubes recalled over an inadequate quality system
ASP Global is recalling 2,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres, over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0544-2026·2025-11-26
Lithium heparin microtubes recalled over an inadequate quality system
ASP Global is recalling 78,000 SAFE-T-FILL micro capillary blood collection tubes, 125 microlitres with lithium heparin, over an inadequate quality system.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0563-2026·2025-11-26
Balanced heparin capillary tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 121,750 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres, over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0553-2026·2025-11-26
Sodium fluoride microtubes recalled over an inadequate quality system
ASP Global is recalling 2,100 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with sodium fluoride, over an inadequate quality system.
Product
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0559-2026·2025-11-26
Untreated blood gas tubes recalled over an inadequate quality system
ASP Global is recalling 77,500 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres untreated, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0564-2026·2025-11-26
Capillary end caps recalled over an inadequate quality system
ASP Global is recalling 620,502 SAFE-T-FILL end caps for blood gas capillaries over an inadequate quality system with unvalidated manufacturing processes.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0561-2026·2025-11-26
Larger sodium heparin capillary tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 947,100 SAFE-T-FILL plastic blood gas capillary tubes, 150 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0550-2026·2025-11-26
Plasma separator tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 9,150 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.
Product
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 t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0545-2026·2025-11-26
Red serum separator tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 50,050 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with clot activator and serum separator gel, over an inadequate quality system.
Product
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 f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0556-2026·2025-11-26
Untreated hematocrit tubes recalled over an inadequate quality system
ASP Global is recalling 209,000 SAFE-T-FILL microhematocrit capillary tubes, 50 microlitres untreated, over an inadequate quality system with unvalidated processes.
Product
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0566-2026·2025-11-26
Capillary mixing fleas recalled over an inadequate quality system
ASP Global is recalling 50,250 mixing fleas for SAFE-T-FILL blood gas capillaries over an inadequate quality system with unvalidated processes.
Product
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0552-2026·2025-11-26
Three hundred microlitre heparin tubes recalled over unvalidated manufacturing processes
ASP Global is recalling 6,050 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with lithium heparin, over an inadequate quality system.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0567-2026·2025-11-26
Micro collection tube extenders recalled over an inadequate quality system
ASP Global is recalling 27,100 SAFE-T-FILL micro collection tube extenders over an inadequate quality system with unvalidated manufacturing processes.
Product
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0562-2026·2025-11-26
Sodium heparin blood gas tubes recalled over an inadequate quality system
ASP Global is recalling 160,250 SAFE-T-FILL plastic blood gas capillary tubes, 230 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0560-2026·2025-11-26
Sodium heparin capillary tubes recalled over an inadequate quality system
ASP Global is recalling 1,000 SAFE-T-FILL plastic blood gas capillary tubes, 115 microlitres with sodium heparin, over an inadequate quality system.
Product
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0005 Product Description: A clear, plastic capillary blood collection tube
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0549-2026·2025-11-26
Plasma separator microtubes recalled over an inadequate quality system
ASP Global is recalling 49,000 SAFE-T-FILL micro capillary blood collection tubes, 200 microlitres with lithium heparin and plasma separator gel, over an inadequate quality system.
Product
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 th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0548-2026·2025-11-26
Three hundred microlitre clot activator tubes recalled over quality system findings
ASP Global is recalling 6,600 SAFE-T-FILL micro capillary blood collection tubes, 300 microlitres with clot activator, over an inadequate quality system.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0173-2026·2025-10-22
Labor and delivery packs recalled after being sterilized more than once
American Contract Systems is recalling labor, delivery and birthing room convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK
Category
Medical Device
Distribution
Distributed nationwide