The Recall Desk

Hazard

Seal Defect recalls

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

What the numbers show

Total
117
Critical
1
Severe
4
Most recent
2026-08-12

Of the 117 seal defect recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (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 seal 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.

1–25 of 117

  • HighFDA (Devices)·Z-2858-2026·2026-08-12

    Medical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect

    Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.

    Product
    Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2772-2026·2026-07-29

    Halyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect

    AVID Medical is recalling 112 Halyard STANDARD LINE INSERTION PACKs due to silicone seal defects that may cause fluid leakage or occlusion.

    Product
    Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2737-2026·2026-07-22

    Medline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled

    Medline Industries is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal defects that risk sterility breach during surgical procedures.

    Product
    Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2736-2026·2026-07-22

    Medline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects

    Medline is recalling 163 kits containing Zimmer Biomet mixing bowls and spatulas due to seal nonconformities that may compromise sterility. The defect could require extended surgery time to locate an alternative device.

    Product
    Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2026·2026-03-04

    Medline Kits with Tego Connectors Recalled Due to Silicone Seal Defects

    Medline Industries, LP is recalling specific Medline Kits containing Tego Connectors because the silicone seals may dome or tear, potentially causing fluid leakage or blocked paths.

    Product
    Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0227-2026·2025-12-17

    Sertraline tablets recalled because bottle seals are not adhering

    Lupin Pharmaceuticals is recalling 52,128 bottles of Sertraline Hydrochloride Tablets, 100 mg, over a defective container in which the seal is not adhering to the bottles.

    Product
    SERTRALINE HYDROCHLORIDE — SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0198-2026·2025-12-10

    Testosterone gel packets recalled over a side-seal defect allowing leakage

    Teva Pharmaceuticals USA is recalling 15,944 cartons of Testosterone Gel 1% unit-dose packets because a defect in the side-seal allows leakage of product.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0273-2025·2025-07-23

    New Mexico Pinon single serve coffee cup ink can run

    New Mexico Pinon Coffee Dark Pinon Single Serve cups are being recalled because an inconsistent clear coat seal allows the food safe ink printing to run in a K-cup machine. 154 units affected.

    Product
    New Mexico Pinon Coffee. Dark Pinon Single Serve 10ct. Product Number:F03308 UPC:812361033081. Single Serve (Keurig) Cups, filled with ground coffee flavored with natural flavorings.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2025·2025-06-04

    Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach

    Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.

    Product
    Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1882-2025·2025-06-04

    Segmental Stem Bowed 152MM components recall potential seal breach

    Onkos Surgical is recalling Segmental Stem, Canal Filling, Bowed 152MM components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise the sterility of the device.

    Product
    Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1604-2025·2025-04-23

    Medline Convenience Kits Recalled for Potential Breather Pouch Seal Defects

    Medline is recalling select IV convenience kits due to potential open or weak seals on breather pouches used for packaging. The defective seals may compromise sterility of the medical devices.

    Product
    Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2025·2025-04-23

    Medline Convenience Kits Recalled for Potential Open or Weak Seals

    Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling sterile convenience kits with select breather pouches that may have open or weak seals, potentially compromising sterility. Affected units were distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.

    Product
    Refer to RES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2025·2025-04-23

    Medline pacemaker drape pack convenience kits recalled for seal defects

    Medline is recalling its Custom Pacemaker Drape Pack (Model DYNJCD0339) due to potential weak or open seals on breather pouches used in sterile convenience kits.

    Product
    Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2025·2025-04-23

    Medline Sterile Convenience Kits Recalled for Defective Breather Pouches

    Medline Industries is recalling select sterile convenience kits due to the potential for open or weak seals on breather pouches used in packaging. Affected units were distributed nationwide and internationally.

    Product
    Refer to RES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2025·2025-04-23

    Medline Convenience Kits Recalled for Potential Weak Breather Pouch Seals

    Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The issue affects 116 units distributed worldwide.

    Product
    Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1602-2025·2025-04-23

    Sterile convenience kits recalled for potentially weak breather pouch seals

    Medline Industries is recalling sterile convenience kits due to potential open or weak seals on breather pouches used in packaging. Defective seals may compromise product sterility.

    Product
    Refer to RES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2025·2025-04-09

    Stryker Nasopore Nasal Dressing Recalled for Compromised Sterility Seals

    Stryker's Nasopore 8cm nasal dressing is being recalled because packaging seals may have bubbles indicating the sterility barrier has been breached. The recall affects 182,344 units distributed nationwide.

    Product
    Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2025·2025-04-09

    Nasopore Standard Nasal Dressing Recalled Due to Sterility Seal Defects

    Stryker is recalling 182,344 units of Nasopore Standard nasal dressings nationwide due to potential bubbles in blister seals that may breach the sterility barrier and increase contamination risk.

    Product
    Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1469-2025·2025-04-09

    Otopore Outer Ear Dressings Recalled for Compromised Sterile Packaging Seals

    Stryker Corporation is recalling 182,344 Otopore Cylinder Standard outer ear dressings due to potential defects in blister seals that may compromise sterility. Bubbles in packaging seals indicate the sterile barrier is breached.

    Product
    Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1479-2025·2025-04-09

    Nasal dressing recall: potential sterile barrier breach from seal defect

    Stryker is recalling over 182,000 Nasopore nasal dressings due to potential bubbles in the blister seal that could compromise the sterile barrier. The affected units were distributed nationwide.

    Product
    Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0174-2025·2025-01-08

    Injectable phenylephrine recalled due to defective tamper-evident seals nationwide

    Hikma Injectables is recalling phenylephrine injections nationwide because tamper-evident seals on some syringes were not properly attached. Affected lot 243120003D has a use-by date of 03/11/2025.

    Product
    phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0264-2025·2024-12-18

    Jarritos Coconut Water recalled due to compromised can seals

    Tipp Distributors is recalling Jarritos Coconut Water 17.5 fl oz cans due to potentially compromised hermetic seals on the lids. The recall affects 169,438 cases distributed in 29 U.S. states.

    Product
    Jarritos Coconut Water 17.5 fl oz cans- 12 cans per carton
    Category
    Food
    Distribution
    29 states
  • HighFDA (Devices)·Z-3092-2024·2024-09-18

    Medline ReNewal Reprocessed LigaSure Blunt Tip Recalled for Packaging Seal Defect

    Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0564-2024·2024-07-03

    Buprenorphine Injection Recalled Due to Incomplete Seal Integrity Issue

    Pfizer is recalling specific lots of Buprenorphine Hydrochloride Injection due to potential incomplete crimp seals that could compromise product sterility. Patients using affected lots should consult their healthcare provider.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide