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.

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.

251–275 of 1612

  • HighFDA (Devices)·Z-0933-2023·2023-01-18

    Cystoscopy kits recalled for potential sterility breach from packaging defects

    Henry Shein CYSTO SET UP PACK units are being recalled due to potential pinhole leaks in the outer bag that could compromise the sterility of the kit.

    Product
    Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0944-2023·2023-01-18

    Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise

    Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.

    Product
    Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2023·2023-01-18

    Stradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk

    Stradis Healthcare is recalling Foley Catheter Insertion Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 920 units distributed across multiple US states.

    Product
    Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2023·2023-01-18

    Neonatal PICC Tray Recalled Due to Potential Sterility Breach

    Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.

    Product
    Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2023·2023-01-18

    DeRoyal surgical procedure pack recalled for sterile barrier defect

    DeRoyal is recalling certain surgical procedure packs containing Medtronic non-absorbable sutures due to a manufacturing error that may breach the sterile barrier protecting the surgical field.

    Product
    DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2023·2023-01-18

    HCT MAX BARRIER PICC Insertion Tray Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.

    Product
    HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2023·2022-12-21

    Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk

    Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.

    Product
    STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2023·2022-11-09

    Medline Dental Pack Recall Due to Breather Pouch Seal Defect

    Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.

    Product
    MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0007-2023·2022-10-12

    Zimmer G7 Acetabular System shells recalled due to packaging defect

    Zimmer, Inc. is recalling certain G7 Acetabular System acetabular shells (52 MM and 60 MM) because the outer sterile package has corner walls thinner than specification, which could crack during transit and potentially lead to surgical complications or infection.

    Product
    G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2022·2022-10-05

    Cope Mandril Wire Guide Guidewires Recalled for Packaging Seal Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.

    Product
    Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2022·2022-10-05

    Cook Roadrunner Guidewire Recalled for Compromised Sterile Packaging Seal

    Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.

    Product
    Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2022·2022-10-05

    Cook Roadrunner PC Guidewires Recalled for Compromised Packaging Sterility

    Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires due to potential packaging seal breaches that may compromise device sterility. Affected devices were distributed in the United States and internationally.

    Product
    Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2022·2022-10-05

    FDA Recalls Cook Roadrunner PC Wire Guides for Packaging Sterility Breach

    Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.

    Product
    Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2022·2022-10-05

    Roadrunner PC Wire Guide Recalled for Packaging Breach and Sterility Compromise

    Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide and internationally.

    Product
    Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2022·2022-10-05

    Cope Nitinol Guidewire Recalled Due to Packaging Sterility Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide (Nitinol) devices because the packaging's chevron seal may be completely breached, potentially compromising sterility. The recall affects 1,501 US units and 380 international units.

    Product
    Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1846-2022·2022-10-05

    Cook Movable Core Wire Guide Guidewires Recall Due to Packaging Defect

    Cook Incorporated is recalling specific lots of Movable Core Wire Guide guidewires due to a potential breach of the packaging seal that may compromise device sterility.

    Product
    Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2022·2022-10-05

    Vinyl Connecting Tubes Recalled Due to Packaging Seal Breach

    Cook Incorporated is recalling Vinyl Connecting Tubes because of a complete breach of the chevron seal in the packaging, which may compromise device sterility.

    Product
    Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2022·2022-10-05

    Medical Guidewire Recalled for Packaging Defect Affecting Sterility

    Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires due to a packaging defect where the chevron seal may be breached, potentially compromising device sterility.

    Product
    Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2022·2022-10-05

    Cook Rosen Curved Wire Guide Recall: Sterility Concerns

    Cook Incorporated is recalling specific lots of Rosen Curved Wire Guide guidewires due to a complete breach of the packaging seal that may compromise device sterility. Affected devices were distributed nationwide in the US and worldwide.

    Product
    Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging and Accelerated Wear Risk

    Exactech's GXL acetabular hip implant liners are being recalled because they were packaged in non-conforming bags that may cause accelerated wear of the devices.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2022·2022-09-21

    Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear

    Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were distributed worldwide.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging Bags

    Exactech recalls GXL acetabular hip implant liners packaged in non-conforming bags that may cause premature wear. No injuries have been reported.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging

    Exactech recalled 132 GXL acetabular liners (hip implant components) due to non-conforming bags that may accelerate device wear. Units were distributed worldwide to the US and 13 countries.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise

    Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure that may compromise sterility. No illnesses have been reported.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2022·2022-09-21

    GXL Acetabular Liners Packaging Defect May Cause Accelerated Wear

    Exactech GXL acetabular hip implant liners in non-conforming bags may experience accelerated wear. Approximately 7,946 devices were distributed worldwide. No injuries have been reported.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER…
    Category
    Medical Device
    Distribution
    Distributed nationwide