Hazard

Process Monitoring recalls

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

What the numbers show

Total: 15
Critical: 0
Severe: 0
Most recent: 2025-07-30

Of the 15 process monitoring 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 process monitoring 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.

1–15 of 15

ModerateFDA (Devices)·Z-2157-2025·2025-07-30
EasiSlush sterile slush solution missed a quarterly gamma sterilization dose audit
Bridge to Life EasiSlush is being recalled because quarterly dose audits monitoring the gamma sterilization process were not completed on time for three lots in the first quarter of 2024. 4,528 units affected.
Product
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-1650-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1653-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1645-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 hip stem cement spacer molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1640-2020·2020-04-15
Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
Biomet, Inc. is recalling StageOne Hip Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1657-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling 230,001 units of StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1656-2020·2020-04-15
Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes and inadequate process monitoring.
Product
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1651-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1661-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1658-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1669-2020·2020-04-15
Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns
Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1652-2020·2020-04-15
Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns
Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1644-2020·2020-04-15
Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes and inadequate monitoring.
Product
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1659-2020·2020-04-15
Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-1668-2020·2020-04-15
Biomet Knee Tibial Cement Spacer Mold Recalled for Cleaning Process Concerns
Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.
Product
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
Category
Medical Device
Distribution
49 states