The Recall Desk

Hazard

Packaging Defect recalls

1,604 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,604
Critical
2
Severe
82
Most recent
2026-09-09

Of the 1,604 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 82 (5%) 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 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.

1576–1600 of 1604

  • ModerateFDA (Devices)·Z-0982-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.

    Product
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0985-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0980-2013·2013-04-03

    Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects

    Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.

    Product
    Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Dou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0891-2013·2013-03-06

    Myco Medical Recalls Technocut Plus Safety Scalpels Due to Sterility Concerns

    Myco Medical is recalling Technocut Plus safety scalpels due to labeling errors and defective packaging that may compromise sterility.

    Product
    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0879-2013·2013-03-06

    Baylis Medical Recalls Unsealed Sterile RF Cannulas for Pain Relief

    Baylis Medical is recalling 1,780 sterile RF cannulas distributed to Australia because some pouches were not sealed, risking sterility loss.

    Product
    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined num
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0842-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Packaging Integrity Issues

    Codman & Shurtleff is recalling 867 NeuroPath guiding catheters because packaging defects may compromise sterility. The devices were distributed worldwide.

    Product
    NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2013·2013-02-13

    Allergen Medical Recalls SeriScaffold Surgical Scaffold Due to Sterility Concerns

    Allergen Medical is recalling SeriScaffold Surgical Scaffold units because the outer packaging seal may be compromised, potentially compromising sterility.

    Product
    SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Drugs)·D-146-2013·2013-02-13

    Ascend Recalls EstroGel Pump Defect

    Ascend Therapeutics is recalling 4,835 bottles of EstroGel (estradiol gel) 0.06% because the pump head may detach from the canister.

    Product
    EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215***
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·13110·2013-01-31

    MegaFood One Daily Supplement Bottles Recalled for Non-Child-Resistant Packaging

    FoodState Inc. is recalling MegaFood One Daily Supplement bottles because they lack required child-resistant packaging. The tablets contain iron, which poses a serious risk to young children.

    Product
    MegaFood One Daily Supplement Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-136-2013·2013-01-30

    Flanax Antacid Recalled for Missing Tamper-Evident Cap Band

    Belmora LLC is recalling 17,996 bottles of Flanax antacid because the caps lack a tamper-evident breakaway band.

    Product
    Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0330-2013·2012-11-28

    GE Healthcare Recalls Fetal Scalp Electrodes Due to Packaging Seal Issues

    Vital Signs Devices is recalling 126 cases of Corometrics Qwik Connect Plus Spiral Electrodes because 30 units had incomplete package seals and missing lot numbers.

    Product
    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0293-2013·2012-11-28

    Ethicon Recalls Surgiflo Hemostatic Matrix Kits Due to Packaging Defect

    Ethicon is recalling Surgiflo Hemostatic Matrix kits because a potential cut in the packaging could breach the sterile Tyvek pouch.

    Product
    ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applyi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0427-2013·2012-11-28

    King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices

    King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to EtO sterilization indicators that failed to change color.

    Product
    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0292-2013·2012-11-28

    Ethicon Surgiflo Hemostatic Matrix Kit Packaging Defect Recall

    Ethicon is recalling Surgiflo Hemostatic Matrix Kits due to a packaging defect that could breach the Tyvek pouch.

    Product
    ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0276-2013·2012-11-21

    Progressive Medical Recalls Endoscopic Dissectors with Broken Sterile Seals

    Progressive Medical Inc. is recalling 70 boxes of PMI Endoscopic Dissectors because some sterile packages had broken seals, potentially compromising sterility.

    Product
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0253-2013·2012-11-14

    Siemens Dimension Vista Homocysteine Reagent Cartridges Recalled for Leaking

    Siemens Healthcare Diagnostics is recalling 583 cartons of Dimension Vista Homocysteine Reagent Cartridges because they are leaking from their wrappers.

    Product
    Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocystein
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2447-2012·2012-10-03

    Applied Medical Recalls Biliary Catheters Due to Packaging Particulate Matter

    Applied Medical is recalling specific lots of biliary catheters because packaging particulate matter may reside on the product.

    Product
    Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1658-2012·2012-08-29

    VistaPharm Recalls Xactdose Phenytoin Oral Suspension Due to Container Defects

    VistaPharm is recalling Xactdose Phenytoin Oral Suspension because defective container lids allow moisture loss, potentially causing viscosity and assay failures.

    Product
    Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2081-2012·2012-08-01

    Mallinckrodt Recalls Unsealed Handi-Fil Disposable Syringe Fill Tubes

    Mallinckrodt Inc is recalling 75 cases of Handi-Fil Disposable Syringe Fill Tubes because ten packages were reported as not sealed.

    Product
    The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1404-2012·2012-07-11

    Imodium Multi-Symptom Relief Caplets Recalled for Defective Containers

    McNeil Consumer Healthcare is recalling Imodium Multi-Symptom Relief Caplets due to defective containers and damaged blister units.

    Product
    Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2012·2012-07-04

    Hartmann Sterilux Gauze Sponges Recalled for Sterile Barrier Defects

    Hartmann USA is recalling Sterilux gauze sponges because micro holes were found in the sterile barrier, potentially compromising sterility.

    Product
    Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2012·2012-06-27

    Genzyme Recalls Seprafilm Adhesion Barrier Packs Due to Packaging Defect

    Genzyme is recalling Seprafilm Procedure Packs because a packaging defect may compromise the product's sterility. The recall affects units distributed in the US and South Korea.

    Product
    seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·11266·2011-06-30

    Live Better Vitamins Recalled for Failing Child-Resistant Packaging Requirements

    International Vitamin Corporation is recalling Live Better One Daily and Complex Vitamin B50 tablets because the bottles do not meet child-resistant closure standards.

    Product
    Live Better One Daily Tablets and Live Better Complex Vitamin B50 Tablets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·11748·2011-06-30

    GNC Recalls Women's Multivitamins for Missing Child-Resistant Caps

    GNC is recalling specific lots of women's multivitamins because the bottles lack required child-resistant closures, posing a risk of serious injury to children.

    Product
    GNC Women's Ultra Mega®, Ultra Mega Active, Ultra Mega Energy and Metabolism, and GNC Prenatal Formula with Iron multivitamins
    Category
    Consumer Product
    Distribution
    Distributed nationwide