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.

301–325 of 1612

HighFDA (Devices)·Z-0537-2022·2022-02-09
DIXI Medical Microdeep Depth Electrode Packaging Defect Threatens Sterile Barrier
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential packaging deformation that could compromise the sterile barrier. Approximately 2,720 units were distributed nationwide for use in brain recording and stimulation procedures.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0539-2022·2022-02-09
DIXI Medical Depth Electrodes recalled for potential sterile packaging defect
DIXI MEDICAL USA is recalling 461 Microdeep Depth Electrodes. The internal blister packaging may deform, potentially compromising the sterile barrier when removed from the protective Tyvek bag.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2022·2022-02-09
DIXI Medical Microdeep Depth Electrode packaging defect may compromise sterility
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential deformation of the internal packaging (blister pack) that could compromise the sterile barrier. The recall affects 365 units distributed nationwide.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2022·2022-02-09
DIXI Microdeep Depth Electrode packaging deformation poses sterility risk
DIXI Medical USA is recalling 2,141 Microdeep Depth Electrodes nationwide due to potential deformation of the blister pack that could compromise the sterile barrier when devices are removed from their Tyvek bags.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2022·2022-02-09
FDA Recalls DIXI Medical Microdeep Depth Electrodes Due to Packaging Defect
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes nationwide due to potential internal packaging deformation that could compromise the device's sterile barrier.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2022·2022-02-09
DIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility
DIXI MEDICAL USA is recalling 1792 Microdeep Depth Electrodes due to potential deformation of the internal blister pack that could compromise the sterile barrier when the device is removed from its Tyvek bag.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0544-2022·2022-02-09
Medical device control product pouches mislabeled with incorrect catalog number
Microbiologics Inc recalls KWIK-STIK IVD control product (lot 323-108-7) containing 47 packs due to pouches being labeled with incorrect catalog number 726-57-10 instead of correct labeling.
Product
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-0405-2022·2021-12-29
Malosa Core LASIK Pack Recalled for Sterility-Compromising Packaging Defects
Beaver Visitec International recalls 920 units of Malosa Core LASIK Pack due to packaging holes that may compromise product sterility. Compromised sterility creates infection risk in surgical use.
Product
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0407-2022·2021-12-29
Cataract Surgery Kits Recalled for Compromised Sterile Packaging
Beaver Visitec is recalling Malosa Core Phaco Pack 1 cataract surgery kits (Part Number: MMK833/2) because packaging may have small holes that compromise product sterility. The recall affects 120 units distributed across nine states.
Product
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0406-2022·2021-12-29
Surgical Corneal Kit Packaging May Compromise Product Sterility
Beaver Visitec is recalling the Malosa Core Surface Treatment Pack surgical kit because packaging may have holes that compromise sterility during eye procedures.
Product
Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0410-2022·2021-12-29
Medical Refractive Surgery Kit Recalled for Sterility-Compromising Packaging Defects
Beaver Visitec is recalling 1,170 units of its Malosa Core SMILE Pack 2 surgical refractive kit because packaging may contain small holes that could compromise sterility. Affected units were distributed across nine states.
Product
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0408-2022·2021-12-29
Malosa Core Phaco Pack 2 Surgical Kit Recalled for Packaging Sterility Risk
Beaver Visitec International is recalling the Malosa Core Phaco Pack 2 medical refractive kit due to small holes in the kit packaging that may compromise product sterility.
Product
Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0375-2022·2021-12-22
Cardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals
Cardinal Health is recalling 364,481 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential for open packaging seals that could compromise sterility. The recalled units were distributed worldwide.
Product
RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2022·2021-12-22
Surgical gowns recalled due to potential compromised sterility from packaging seals
Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.
Product
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2022·2021-12-22
Cardinal Health Surgical Gowns Recalled for Potential Sterility Compromise
Cardinal Health is recalling approximately 17,174 Poly-Reinforced Surgical Gowns (Large, SKU 9010) due to potential compromise of packaging seals that could affect product sterility. Units were distributed worldwide.
Product
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0378-2022·2021-12-22
Cardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise
Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.
Product
RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0373-2022·2021-12-22
Cardinal Health Surgical Gowns X-Large Recalled for Packaging Seal Defect
Cardinal Health is recalling 146,939 units of Poly-Reinforced Surgical Gowns (X-large, SKU 9040) due to potential compromised packaging seals that could affect sterility. Affected products were distributed worldwide.
Product
Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0374-2022·2021-12-22
Cardinal Health Surgical Gowns Recalled Due to Compromised Packaging Seals
Cardinal Health Poly-Reinforced Surgical Gowns (XX-large, SKU 9070) are recalled due to potential open packaging seals that could compromise sterility. Approximately 29,893 units distributed worldwide may be affected.
Product
Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0370-2022·2021-12-22
Surgical Gowns Recalled Due to Potential Packaging Seal Defects
Cardinal Health is recalling SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns (X-Large, SKU 9041) due to potential open packaging seals that could compromise sterility. The recall affects 231,219 units distributed worldwide.
Product
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0216-2022·2021-12-01
Mr. Special Jugo de Pina Concentrated Pineapple Juice Recalled for Swollen Cans
Empresas La Famosa, Inc. is recalling Mr. Special Jugo de Pina De Concentrado 46 oz cans due to swollen cans discovered during production. The recall affects 409 cases distributed in Puerto Rico.
Product
Mr. Special Jugo de Pina De Concentrado, 46 oz cans, packaged cardboard boxes 12 cans per case of 46 oz each
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0026-2022·2021-10-13
Exactech OPTETRAK Knee Implant Inserts Recalled for Inadequate Packaging
Exactech is recalling 8,985 OPTETRAK Comprehensive Knee System inserts due to insufficient oxygen barrier protection in vacuum packaging. The packaging deficiency was identified as the basis for the recall.
Product
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0021-2022·2021-10-13
OPTETRAK LOGIC Tibial Inserts recalled for inadequate packaging oxygen barrier
Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.
Product
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0023-2022·2021-10-13
TRULIANT Knee System tibial inserts recalled for packaging oxygen barrier defect
Exactech is recalling 31,201 TRULIANT Knee System tibial inserts whose packaging lacks an oxygen barrier layer. The implants were distributed worldwide.
Product
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0027-2022·2021-10-13
ARTHROFOCUS Polyethylene Tibial Inserts recalled for packaging defect
Exactech is recalling ARTHROFOCUS Polyethylene Tibial Inserts due to packaging defects. Inserts lacked an oxygen barrier layer in their vacuum bag packaging, which could compromise device integrity.
Product
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2022·2021-10-13
Knee replacement system inserts recalled for missing oxygen barrier in packaging
Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.
Product
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide