The Recall Desk

Hazard

Seal Failure recalls

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

What the numbers show

Total
133
Critical
1
Severe
3
Most recent
2026-05-20

Of the 133 seal failure recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (2%) 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 seal failure 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 133

  • SevereFDA (Devices)·Z-2192-2026·2026-05-20

    Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled

    Stryker Sustainability Solutions is recalling 107 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility assurance.

    Product
    Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2026·2026-03-04

    Medline dialysis kits recalled over damaged Tego connector silicone seals

    Medline is recalling certain Dialysis On/Off Kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.

    Product
    Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2026·2026-03-04

    Medline apheresis and central line kits recalled over connector seal defects

    Medline is recalling Apheresis Subqport Access Kits and Central Line Insertion kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.

    Product
    Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2026·2026-03-04

    Medline dialysis dressing change kits recalled over connector seal defects

    Medline is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit, because the silicone seal may dome or tear and occlude the fluid path.

    Product
    Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2026·2026-03-04

    Medline dialysis maintenance kits recalled over Tego connector seal defects

    Medline is recalling seven convenience kits used for dialysis maintenance because the silicone seal on the Tego Connectors may dome or tear, which can occlude the fluid path.

    Product
    Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0338-2026·2026-02-18

    Oxycodone blister cards recalled over seals that let tablets fall out

    Amerisource Health Services is recalling 31,676 packages of Oxycodone Hydrochloride Tablets 5 mg over card seal defects that let tablets fall out of their cavities.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2026·2026-01-28

    Needle free access connectors recalled over silicone seals that may tear

    ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.

    Product
    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2026·2025-11-12

    Twenty centimetre straight catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 20 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2026·2025-11-12

    Straight extension catheter trays 24 cm recalled over header bag seals

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions and IC components, 12 Fr x 24 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2026·2025-11-12

    Curved extension catheter trays 20 cm recalled over header bag seals

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with curved extensions, 12 Fr x 20 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2026·2025-11-12

    Straight extension catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays with straight extensions, 12 Fr x 24 cm, over header bag seal integrity.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2026·2025-11-12

    Dialysis catheter trays recalled over seal integrity of header bag packaging

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays, 12 Fr x 16 cm, over a potential issue with the seal integrity of the header bag packaging.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2026·2025-11-12

    Curved extension catheter trays recalled over header bag seal integrity

    Mozarc Medical is recalling 3,258 MAHURKAR acute high pressure triple lumen catheter trays, 12 Fr x 13 cm, over a potential issue with the seal integrity of the header bag packaging.

    Product
    MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2026·2025-11-05

    Chandelier illuminators recalled over incomplete seals in the sterile pouch

    Alcon Research is recalling 330 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Softwa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2026·2025-11-05

    Infusion line packs recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 25,778 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2026·2025-11-05

    Vitrectomy probe accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 577 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE 8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2026·2025-11-05

    Daily contact lenses recalled over a weak seal compromising sterility

    Alcon Research is recalling 82 units of PRECISION1 One-Day Contact Lenses in -2.25D because some units may have a weak seal that compromises sterility.

    Product
    Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0308-2026·2025-11-05

    Entry system accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2026·2025-11-05

    Surgical console accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling six accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Descr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·25313·2025-06-05

    Rinnai i-Series Plus Gas Boilers Recalled for Carbon Monoxide Hazard

    Rinnai America is recalling about 2,030 i-Series Plus gas boilers because the door can fail to seal properly due to incorrect screws, allowing carbon monoxide to escape. No injuries have been reported.

    Product
    Rinnai i-Series Plus gas boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2025·2025-06-04

    NxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk

    NxStage Medical Inc is recalling NxStage PureFlow-B Solution bags nationwide due to potential perimeter seal failure on the small chamber, which could cause electrolyte fluid to splash into the user's face when opening the peel seam to mix chambers before treatment.

    Product
    NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner QBC Seal Adhesive Failure Risk

    Philips is recalling the Intera 1.5T Power/Pulsar MRI scanner because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could injure patients during scanning.

    Product
    Intera 1.5T Power/Pulsar, Model Number: 781105;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1776-2025·2025-05-21

    Philips Intera 1.5T MRI Scanner Body Coil Seal Failure Recall

    Philips is recalling 103 Intera 1.5T MRI scanners worldwide because the Quadrature Body Coil seal adhesive may fail, creating sharp edges that could cause skin abrasions, bruises, lacerations, hair loss, or tissue injury to patients.

    Product
    Intera 1.5T Master/Nova, Model Number: 781106;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0684-2025·2025-04-09

    SeaBear Salmon Chowder Recalled for Potential Seal Failure and Botulinum Risk

    SeaBear Smokedhouse Salmon Chowder is recalled due to potential seal failure that could allow Clostridium botulinum contamination. The recall affects 11,152 pouches distributed nationwide.

    Product
    SeaBear Smokedhouse Salmon Chowder is packaged in flexible retort pouch, net wt. 12-oz., UPC 0 34507 07001 3. Case label: Item 60077 Salmon Chowder 12/12oz, SeaBear/G&D Anacortes, WA.
    Category
    Food
    Distribution
    Distributed nationwide