The Recall Desk

Hazard

Process Failure recalls

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

What the numbers show

Total
13
Critical
0
Severe
1
Most recent
2020-04-15

Of the 13 process failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (8%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all process failure 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.

1–13 of 13

  • HighFDA (Devices)·Z-1641-2020·2020-04-15

    Biomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1664-2020·2020-04-15

    Biomet Recalls Knee Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling BIOMET StageOne Knee Femoral Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1639-2020·2020-04-15

    Biomet Recalls StageOne Hip Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Hip Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1666-2020·2020-04-15

    Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1667-2020·2020-04-15

    Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Food)·F-3488-2017·2017-09-27

    Kilby Cream Ice Cream Recalled Due to Temperature Deviation

    Kilby Cream is recalling Almond Delight ice cream because proper temperatures were not reached during production and storage.

    Product
    Kilby Cream Ice Cream, Almond Delight Size: 7 oz. and Gallon
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1680-2014·2014-06-11

    Bacterin Elutia Wound Drains Recalled for Missing Dose Audits

    Bacterin International is recalling Elutia Hubless Coated Silicone Surgical Wound Drains because quarterly dose audits were omitted. The products were appropriately sterilized.

    Product
    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0726-2014·2013-12-11

    Oma's Choice Recalls Pickled Quail Eggs Due to Process Authority Failure

    Oma's Choice Inc is recalling pickled quail eggs because the products were not submitted to a process authority for evaluation.

    Product
    Oma's Choice, Pickled Quail Eggs, Net. Wt. 16 oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1052-2013·2013-04-24

    Stryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues

    Stryker Orthopaedics is recalling ShapeMatch Cutting Guides used in knee surgeries due to potential issues with internal planning and production processes.

    Product
    ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1193-2013·2013-03-20

    Rose Valley Salted Print Butter Recalled for Antibiotic Testing Failure

    Farmers Cooperative Creamery is recalling Rose Valley Salted Print Butter because the milk used was not confirmed negative for antibiotics before processing.

    Product
    Salted Print Butter, Rose Valley brand. Product is packaged in 1 lb. unit package, 36 units per case. The UPC is 0 32395 09322 0. The product is labeled in parts: "***ROSE VALLEY***SWEET CREAM BUTTER***NET WT. 16OZ***MFD. BY FARMERS CO-OPERATIVE CREAMERY***McMINNVILLE***ORE*
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1802-2012·2012-08-01

    Meiko Foods Recalls Tempura Due to Missing HACCP Plans

    Meiko Foods Co. Inc. is recalling 12 oz. Tempura products because they were cooked without HACCP plans to control known hazards.

    Product
    Meiko Foods Co. Inc. Tempura, 12 oz. Product labeling reads in part:" MEIKO***TEMPURA ***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1803-2012·2012-08-01

    Meiko Pollock Fish Balls Recalled for Lack of HACCP Plan

    Meiko Foods is recalling Pollock Fish Balls because they were cooked without HACCP plans to control known hazards.

    Product
    Meiko Foods Co. Inc. Pollock Fish Balls , 2-10 lb bags. Product labeling reads in part:" MEIKO***POLLOCK FISH BALL S***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1804-2012·2012-08-01

    Meiko Cooked Cuttlefish Ball Recalled for Lack of HACCP Plan

    Meiko Foods is recalling cooked cuttlefish balls because they were processed without a HACCP plan to control known hazards.

    Product
    Meiko Foods Co. Inc. Cooked Cuttlefish Ball, 2-10 lb bags . Product labeling reads in part:" MEIKO***Muc Vien [Vietnamese] ***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state