The Recall Desk

Hazard

Packaging Defect recalls

1,612 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,612
Critical
2
Severe
87
Most recent
2026-10-29

Of the 1,612 packaging defect recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 87 (5%) 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 packaging defect 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.

326–350 of 1612

  • HighFDA (Devices)·Z-0024-2022·2021-10-13

    Vantage Total Ankle System Recalled for Inadequate Packaging Barriers

    Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.

    Product
    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2022·2021-10-13

    Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging

    Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices distributed worldwide.

    Product
    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2022·2021-10-13

    OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier

    Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.

    Product
    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2022·2021-10-13

    OPTETRAK Comprehensive Knee System Custom Inserts Recalled for Packaging Defect

    Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.

    Product
    OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2021·2021-09-29

    C.R. Bard SureStep Foley Catheter Tray Recalled for Sterile Barrier Defect

    C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The recall affects 33,380 units distributed nationwide.

    Product
    Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2021·2021-09-29

    C.R. Bard Foley Catheter Trays Recalled for Packaging Defects

    C.R. Bard is recalling 420 units of Foley catheter care trays nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2536-2021·2021-09-29

    C.R. Bard Foley Catheter Tray recalled for potential packaging defects

    C.R. Bard Inc is recalling approximately 29,890 units of Foley catheter trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.

    Product
    Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2021·2021-09-29

    C.R. Bard Foley Catheter Trays Recalled for Sterile Packaging Defects

    C.R. Bard is recalling 3,980 units of Foley catheter supply kits due to potential packaging defects that may compromise the sterile barrier. No illnesses have been reported.

    Product
    Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2538-2021·2021-09-29

    C.R. Bard Foley Catheter Tray Recalled for Packaging Defects

    C.R. Bard is recalling a Foley catheter tray system due to packaging defects that may compromise the sterile barrier. The recall affects 8,170 units distributed nationwide.

    Product
    Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2021·2021-09-29

    Foley Catheter Drainage Tray System Packaging Defect Recall

    C.R. Bard Inc is recalling a Foley catheter tray system due to potential packaging defects that may compromise the sterile barrier, affecting 1,760 units distributed nationwide.

    Product
    Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2021·2021-09-29

    C.R. Bard Foley Catheter Kits Recalled for Potential Sterile Barrier Defects

    C.R. Bard is recalling 960 units of Foley Tray catheter kits (lot NGFR0101) due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2021·2021-09-29

    C.R. Bard Foley Tray and Drainage Bag Recalled for Packaging Defects

    C.R. Bard is recalling 11,780 Foley Tray units nationwide due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2021·2021-09-29

    C.R. Bard Foley Tray Recalled for Potential Sterile Barrier Packaging Defects

    C.R. Bard Inc is recalling Foley Tray kits nationwide due to potential packaging defects that may compromise the sterile barrier. The product was distributed throughout the United States.

    Product
    Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2021·2021-09-29

    SureStep Foley Catheter Tray Recalled for Packaging Defects

    C.R. Bard is recalling 18,060 units of SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries have been reported.

    Product
    Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2021·2021-09-29

    C.R. Bard Foley Catheter Tray Recalled for Potential Packaging Defect

    C.R. Bard is recalling 11,600 units of its Foley catheter tray assembly nationwide due to potential packaging defects that may compromise the sterile barrier.

    Product
    Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2540-2021·2021-09-29

    C.R. Bard Foley Catheter Care Kits Recalled for Potential Sterile Barrier Defect

    C.R. Bard Inc is recalling Foley catheter care kits (catalog A303416A) because potential packaging defects could compromise the sterile barrier. Approximately 6,440 units were distributed nationwide.

    Product
    Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2533-2021·2021-09-29

    Foley Catheter Tray Packaging Defect Poses Sterile Barrier Risk

    C.R. Bard Inc is recalling a Foley catheter tray due to potential packaging defects that may compromise the sterile barrier. Approximately 1,710 units were distributed nationwide.

    Product
    Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2021·2021-09-29

    C.R. Bard SureStep Foley Catheter Tray Sterile Barrier Defect Recall

    C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2021·2021-09-29

    Foley Catheter Tray Recalled Due to Potential Packaging Defects

    C.R. Bard is recalling 2,660 units of SureStep Foley Catheter Trays nationwide due to potential packaging defects that may impact the sterile barrier.

    Product
    Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2021·2021-09-29

    SureStep Foley Tray Recall: Packaging Defects May Compromise Sterile Barrier

    C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected units were distributed nationwide.

    Product
    Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2021·2021-09-01

    Accu-Chek SmartView Test Strips May Open During Shipment

    Roche is recalling Accu-Chek SmartView Test Strip vials that may open during shipment. The vials can be exposed to humidity, damaging the strips and potentially causing inaccurate glucose readings.

    Product
    Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2021·2021-08-18

    Jamshidi Bone Marrow Biopsy Needles Recalled for Packaging Seal Defects

    Bard Peripheral Vascular Inc. is recalling multiple models of Jamshidi bone marrow biopsy needles due to incomplete or open packaging seals that may compromise sterility. No illnesses or injuries have been reported.

    Product
    TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0651-2021·2021-06-09

    Genpak Bake n Show Cake Trays Recalled for Foreign Objects

    Genpak is recalling Bake n Show Round and Square Cake Trays due to the presence of foreign objects found in product packaging. The trays were distributed across multiple U.S. states and Canada.

    Product
    Bake n Show¿ Cake Tray Round & Bake n Show¿ Cake Tray Square
    Category
    Consumer Product
    Distribution
    24 states
  • ModerateFDA (Food)·F-0548-2021·2021-05-26

    Faribault Foods Recalls S&W Organic Black Beans Due to Compromised Seals

    Faribault Foods is recalling S&W Organic Black Beans because some cans have compromised hermetic seals. Consumers should check their cans and return them for a refund.

    Product
    S&W Organic Black Beans, 15 oz. can, Distributed by: Faribault Foods, 3401 Park Ave NW, Faribault, MN 55021.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0485-2021·2021-05-19

    South Coast Baking Recalls Chocolate Chip Cookie Cakes Due to Packaging Particles

    South Coast Baking Co. is recalling 12-inch chocolate chip cookie cakes because loose CPET packaging particles may be embedded in the product.

    Product
    SCB 12" Chocolate Chip Cookie Cake In CPET Tray with lid. Keep Frozen 0 Degrees F. Net Wt. 36.00 lbs. (16.33 kg) Case count: 25 Item # 167557 Allergen Warning: Contains: Egg, Milk, Soy, Wheat Do no consume raw. Bake time and temP Oven 330F x 12-16 minutes
    Category
    Food
    Distribution
    2 states