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.

26–50 of 133

  • HighFDA (Food)·F-0685-2025·2025-04-09

    SeaBear Clam Chowder Recalled for Potential Botulinum Contamination

    SeaBear Smokedhouse Alehouse Clam Chowder pouches are recalled nationwide due to potential seal failure that could allow Clostridium botulinum contamination. Consumers should not consume the product.

    Product
    SeaBear Smokedhouse Alehouse Clam Chowder is packaged in retort pouch, net wt. 12-oz., UPC 0 34507 07021 1. Case label, item 60104, Alehouse Chowder 12/CS.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2025·2025-01-15

    Beckman Coulter PTH Assay Reagent Packs Recalled for Filling Defects

    Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.

    Product
    Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2025·2025-01-01

    Medline Reprocessed Bruns Curette Surgical Instruments Recalled for Weak Sterile Seals

    Medline is recalling 21,440 reprocessed Bruns curettes due to weak sterile seals that may fail without user detection. This increases the risk of contamination and infection.

    Product
    ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2025·2024-10-30

    Medline Centurion EP LAB INSTRUMENT KIT Recalled for Potential Sterility Compromise

    Medline Industries is recalling 90 units of Centurion EP LAB INSTRUMENT KIT convenience kits from lot 23LBK889. The kits may contain non-sterile product if the breather pouch vendor seal is opened or compromised.

    Product
    Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2025·2024-10-30

    Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging

    Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.

    Product
    Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0153-2025·2024-10-30

    Medline Procedure Kits Recalled for Non-Sterile Product Risk

    Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3263-2024·2024-10-02

    Ostomy barrier seals recalled for blistering and incorrect model labeling

    T.G. Eakin Limited is recalling blistered Cohesive seal ostomy barriers in Kentucky that are mislabeled with incorrect model numbers.

    Product
    eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2230-2024·2024-07-10

    Medline surgical convenience kits recalled for weak seal integrity

    Medline surgical convenience kits containing Pure Pouch components with weak seals may fail to maintain sterility, potentially compromising the safety of contained medical instruments. Affected kits were distributed nationwide across 23 states.

    Product
    Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2024·2024-07-10

    Medline surgical convenience kits recalled due to weak Pure Pouch seals

    Medline is recalling over 7,600 Open Heart surgical convenience kits nationwide due to weak seals on the Pure Pouch component. The seals may fail and compromise the sterility of the surgical instruments inside.

    Product
    Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2024·2024-07-10

    Surgical Convenience Kits Recalled for Weak Seals Affecting Sterility

    Medline Industries recalls 7,673 surgical convenience kits due to weak Pure Pouch seals that may compromise sterility. Kits were distributed nationwide to healthcare facilities.

    Product
    Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2024·2024-04-10

    Centurion Manual Surgical Kits Recalled Due to Weak Seal

    Medline Industries is recalling Centurion manual surgical kits due to weak seals that may compromise sterility. Approximately 7,950 units were distributed nationwide and internationally.

    Product
    Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2024·2024-04-10

    Centurion Surgical Hook Kits Recalled Due to Weak Seal

    Medline Industries is recalling 1,520 Centurion surgical hook kits worldwide due to weak seals that may compromise sterility. The seal defect may not be detectable by users.

    Product
    Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I68655
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2024·2024-02-14

    PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks

    Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.

    Product
    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0318-2024·2024-02-14

    FDA Recalls Lansoprazole Delayed-Release Capsules Due to Manufacturing Defects

    The FDA is recalling Lansoprazole Delayed-Release Capsules USP 15 mg due to manufacturing defects including inadequate sealing, capsule damage, and missing product codes. Affected lot 411987 was distributed nationwide.

    Product
    Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0949-2024·2024-02-07

    Philips Achieva XR MRI Coil Seal Adhesive Failure Risk

    Philips Achieva XR MRI body coil seal adhesive may fail and create sharp edges that could injure patients. Affected units are being recalled.

    Product
    Achieva XR. Model (REF) Numbers 781153, 781253.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2024·2024-02-07

    Philips Achieva 3.0T MRI Coil Seal Adhesive May Fail, Risking Patient Injury

    The Quadrature Body Coil seal adhesive in Philips Achieva 3.0T MRI scanners may fail, creating sharp edges that can injure patients. All units with model numbers 781277, 781177, 781278, 781344, and 781345 are affected.

    Product
    Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2024·2024-01-24

    Medex LOGICAL CATH LAB KIT Recalled for Oversized O-Ring Defect

    Smiths Medical is recalling the Medex LOGICAL CATH LAB KIT due to a manufacturing defect where the O-ring inner diameter may be oversized, affecting seal integrity and potentially leading to medication under-infusion.

    Product
    Medex LOGICAL CATH LAB KIT, List Number M20754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2024·2024-01-24

    FDA Recalls Medical Pressure Tubing With Defective O-Ring Seals

    Smiths Medical is recalling 31,685 units of pressure tubing with defective O-rings that may not seal properly during medication infusion, potentially causing medication leaks and underdosing. The defect affects specific lot numbers with worldwide distribution.

    Product
    6IN PRESSURE TUBING, List Number MX20617
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0744-2024·2024-01-24

    High Pressure Rotator with O-Ring Seal Defect Recalled Worldwide

    Smiths Medical is recalling High Pressure Rotators due to a manufacturing defect affecting O-ring seals. An oversized inner diameter may cause inadequate seal integrity, risking medication under-infusion.

    Product
    HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2024·2023-11-15

    Blood Lead Test Kits Recalled for Defective Treatment Reagent Caps

    Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits nationwide due to defective plastic caps on reagent tubes. A small percentage of caps may not seal properly, potentially leading to inaccurate test results.

    Product
    LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2088-2023·2023-07-12

    Medical Procedure Packs with Compromised Package Seals Recalled

    DeRoyal Industries is recalling 328 surgical procedure packs because outer package seals could be open or compromised, affecting product sterility. The affected packs are used in operating rooms nationwide.

    Product
    Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1315-2023·2023-04-05

    Disposable Tourniquet Cuffs Recalled Due to Pressure Failure

    Over 127,000 disposable tourniquet cuffs are being recalled because they may fail to achieve or maintain pressure during surgery due to fabric tearing or O-ring defects, risking operative bleeding and hemorrhage.

    Product
    Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135;
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-1283-2023·2023-03-29

    DeRoyal Suction Canister Recalled Due to Lid Shrinkage Seal Defect

    DeRoyal SafeLiner Suction Canister model PHESL-1000B is being recalled due to lid shrinkage that prevents proper vacuum seal formation and maintenance. The recall affects 27,200 devices distributed across multiple US states.

    Product
    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2023·2022-12-21

    Medical Trays Recalled for Potentially Compromised Sterility from Incomplete Sealing

    Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.

    Product
    HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2022·2022-06-08

    Surgical Instrument Seal Defect Recall: da Vinci Energy SynchroSeal

    Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.

    Product
    DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
    Category
    Medical Device
    Distribution
    Distributed nationwide