The Recall Desk

Hazard

Packaging Defect recalls

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

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.

26–50 of 290

  • ModerateFDA (Drugs)·D-0508-2025·2025-07-09

    Prescription Gabapentin Capsules Recalled for Defective Blister Packaging

    The Harvard Drug Group LLC is recalling Gabapentin Capsules due to inadequately sealed blister packaging. Patients should contact their pharmacy or healthcare provider regarding affected lots M05205A and M05205B.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2025·2025-07-02

    Medline umbilical catheter tray recalled for outer packaging defect

    Medline is recalling its UMBILICAL TRAY W/3.5&5FR CATH due to a possible packaging defect in the outer Tyvek pouch. The defect could compromise the sterile protection of the product.

    Product
    Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0491-2025·2025-07-02

    Sodium Chloride Injection recalled for packaging sterility defects

    B Braun Medical is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to pinholes in packaging that compromise sterility assurance in this intravenous product.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2025·2025-06-04

    Cardinal Health Umbilical Catheters Recalled for Packaging Sterility Defect

    Cardinal Health is recalling 10,438 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2025·2025-06-04

    Umbilical Vessel Catheters Recalled for Sterility-Compromising Packaging Defect

    Cardinal Health is recalling 51,378 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in newborns.

    Product
    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2025·2025-06-04

    Umbilical Vessel Catheters Recalled Due to Sterility Packaging Defect

    Cardinal Health recalls 1,710 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile devices could cause infection in newborns.

    Product
    Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2025·2025-06-04

    Umbilical Catheter Insertion Tray Recall Due to Packaging Defect Risk

    Cardinal Health is recalling 370 units of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility, posing infection risk to neonates.

    Product
    Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2025·2025-04-23

    Medline Eye Surgery Convenience Kits Recalled Due to Weak Seal Risk

    Medline is recalling 3,909 ophthalmic surgical convenience kits due to potentially weak or open seals on breather pouches that maintain product sterility. The seal defect could compromise the sterile contents during storage or use.

    Product
    Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2025·2025-04-23

    Medline Pacemaker Drape Packs Recalled for Compromised Packaging Seals

    Medline is recalling pacemaker drape packs due to potential open or weak seals on packaging breather pouches. The affected sterile kits were distributed worldwide including the United States, Canada, Mexico, Panama, and the U.S. Virgin Islands.

    Product
    Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Potential Breather Pouch Seal Defects

    Medline is recalling certain sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. Compromised seals could allow contamination and compromise the sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2025·2025-04-09

    Hemopore nasal wound dressing packaging seal defect may compromise sterility

    Stryker Corporation is recalling 182,344 units of Hemopore nasal/sinus wound dressing due to potential packaging seal defects that could compromise sterility. A bubble on the blister seal may indicate the sterile barrier has been breached.

    Product
    Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2025·2025-04-09

    Otopore Cylinder Wound Dressing Recalled for Potential Sterility Seal Defect

    Stryker Corporation recalls Otopore Cylinder outer ear wound dressing due to potential bubbles in blister seals that may breach the sterile barrier. Affected units were distributed nationwide.

    Product
    Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2025·2025-03-05

    Plato 17 Microcatheter Recall Due to Sterile Barrier Packaging Defect

    Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.

    Product
    Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1168-2025·2025-02-19

    MediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect

    Integra LifeSciences is recalling MediHoney Gel Wound & Burn Dressing Gel (Model 31815) due to potential induction seal defects in the tube packaging. Approximately 12,166 units were distributed worldwide, including throughout the United States and Malaysia.

    Product
    Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney¿ Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2025·2025-02-12

    Surgical sutures recalled for potential sterility breach

    Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.

    Product
    ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2025·2025-01-29

    Dressing Change Kits Recalled for Potential Package Sterility Compromise

    Trinity Sterile is recalling Wolf-Pak Dressing Change Kits due to a potential hole in the package that could compromise the sterility of the medical kit. Lot #600022 (3,960 units) distributed nationwide.

    Product
    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Componen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2025·2025-01-22

    Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2025·2025-01-22

    Surgical Suction Tubes Recalled for Sterile Packaging Defects

    ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Medical Procedure Kits for Sterile Barrier Breach Risk

    Sklar Instruments is recalling 245,015 ECONO STERILE medical procedure kits nationwide due to packaging issues that may compromise the sterile barrier. No illnesses or injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0945-2025·2025-01-22

    Gynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects

    Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2025·2025-01-22

    ECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues

    Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of packaging issues that may breach the sterile barrier.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2025·2025-01-22

    ECONO STERILE Blackhead Extractor Kits Recalled for Sterile Packaging Defects

    Sklar Instruments is recalling ECONO STERILE Schamberg Extractor kits due to packaging issues that may compromise the sterile barrier. The defect could allow contamination of medical instruments.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2025·2025-01-22

    Sklar Instruments Recalls Sterile Vein Hooks Due to Packaging Issues

    Sklar Instruments is recalling 1,050 units of ECONO STERILE Vein Hooks due to packaging issues that may breach the sterile barrier. Products were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) ECONO STERILE VEIN HOOK 2.5MM STERILE CS/25, Model Number 96-4022M; venous proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Trousseau Dilator Kits for Packaging Defects

    Sklar Instruments is recalling ECONO STERILE trousseau dilator kits (Model 941-0191) distributed nationwide due to packaging issues that may compromise the sterile barrier. Affected healthcare providers should stop use immediately.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2025·2025-01-22

    Gynecological Speculum Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE gynecological speculum kits due to packaging issues that may compromise sterility. No injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO STERILE GRAVES SPEC STRL LG BX/25, Model Number 96-2607; 4) ECONO STERILE PEDER
    Category
    Medical Device
    Distribution
    Distributed nationwide