The Recall Desk

Hazard

Package Integrity recalls

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

What the numbers show

Total
97
Critical
0
Severe
3
Most recent
2026-05-13

Of the 97 package integrity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (3%) 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 package integrity 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 97

  • ModerateFDA (Food)·H-0711-2026·2026-05-13

    Horizon Organic chocolate lowfat milk boxes have compromised package integrity

    Horizon Organic Chocolate Organic Lowfat Milk boxes are being recalled because package integrity was compromised. 3,522 cases are affected.

    Product
    Horizon Organic Chocolate Organic Lowfat Milk. Saleable Unit UPC: 742365004322 (6-8 FL OZ Milk Boxes). Case: ORG MILK 1% DHA CHOCOLATE 3/6PK (item 136518). Case UPC: 742365004322. Three 6-Packs, 18-8 FL OZ Containers (236 mL)/case. Individual milk boxes are packed in 8-oz Tetra P
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1114-2025·2025-02-12

    Endodontic Files Recalled for Excess Irradiation Causing Package Integrity Issues

    US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.

    Product
    Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1015-2025·2025-01-29

    Dressing Change Kit Recalled Due to Package Integrity Concern

    Trinity Sterile is recalling Wolf-Pak Premium Dressing Change Kits due to potential holes in packaging that could compromise sterility. The recall affects 5,940 units distributed in Maryland, Pennsylvania, Tennessee, and Texas.

    Product
    Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2025·2024-10-30

    Medline Medical Procedure Kits Recalled for Potential Non-Sterility Risk

    Medline is recalling certain medical procedure kits packaged in breather pouch lot 323080002 because seals may not prevent non-sterile product use. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ3272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0999-2024·2024-02-14

    Surgical hip instruments recalled due to compromised sterility packaging

    Howmedica Osteonics is recalling HRIS ACET CUP surgical instruments used in hip replacement surgery due to failed package seal integrity testing. The recall affects lot-numbered units distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0645-2022·2022-02-23

    Howmedica Dall Miles SM GRIP surgical device recalled for potential package de-bonding

    Howmedica is recalling the Dall Miles SM GRIP device because the outer Tyvek protective package may separate from the sealed unit. The affected batch should be inspected before use.

    Product
    Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0314-2022·2021-12-08

    Orthopedic Implant Head Package Lid May Debond From Sealed Package

    Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.

    Product
    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1744-2020·2020-04-29

    Acuvue Oasys for Astigmatism Contact Lenses Recalled for Package Integrity Failure

    Johnson & Johnson Vision Care is recalling specific Acuvue Oasys for Astigmatism contact lenses due to a package integrity failure found during routine testing.

    Product
    ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Curve 8.6, Refractive Power -3.00D-1.25/90.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 844,000 Sur-vet Needles because a loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1999-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 444,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 22G x 1", Product Code 100211
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2003-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 563,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2000-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Sterility Compromise

    Terumo Medical Corporation is recalling 638,000 Sur-vet Needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1998-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 729,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 20G x 1", Product Code 100204
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-0699-2018·2018-02-07

    Mom's Delicious Kitchen Recalls Kvas Due to Compromised Package Integrity

    Mom's Delicious Kitchen LLC is recalling gallon jugs of Kvas because holes were punched in the lids, compromising package integrity.

    Product
    Kvas, a fermented non-alcoholic drink, packaged in a gallon plastic jugs The label is read in parts: "***Mom's Kvas***1 Gallon***Ingredients: Water, Cane Sugar, Instant Coffee, Yeast, Apple Cider***Home made to your taste with Low Calories! Keep Refrigerated to Prevent from pe
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1478-2016·2016-04-20

    Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 150 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1493-2016·2016-04-20

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 25 arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1468-2016·2016-04-20

    Customed Cesarean Section Surgical Packs Recalled for Sterilization Defects

    Customed, Inc. is recalling 96 Cesarean Section Surgical Packs due to inadequate sterilization validation and package integrity issues.

    Product
    Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1452-2016·2016-04-20

    Customed Arthroscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 18 Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1465-2016·2016-04-20

    Customed Surgical Gowns Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 96 surgical gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1463-2016·2016-04-20

    Customed Cysto TUR Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 72 Cysto TUR Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state