The Recall Desk

Hazard

Sterility Breach recalls

178 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 sterility breach 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 178

  • SevereFDA (Devices)·Z-2196-2026·2026-05-20

    Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which may compromise sterility.

    Product
    Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2026·2026-04-08

    Sterile Radiology Procedure Kits Recalled for Potential Packaging Sterility Breach

    Medline Industries is recalling 420 units of Sterile Radiology Procedure Kits (Model DYNDH1491B, Lot 25GBB924) due to a potential breach in sterile pouch packaging that may compromise product sterility.

    Product
    Sterile Radiology Procedure Kits, Model Number DYNDH1491B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2026·2025-12-24

    Medline Sterile Kelly Forceps Recalled Due to Weak Packaging Seals

    Medline is recalling sterile Kelly forceps (Item DYNJ04048) distributed in CA, CO, IL, KS, and MI. Weak packaging seals may compromise sterility, increasing the risk of infection if the product is used.

    Product
    FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2026·2025-12-24

    Medline Surgical Scissors Recalled Due to Weak Packaging Seals

    Medline Industries is recalling sterile surgical scissors with Item Number DYND04000 due to weak packaging seals that may breach sterility. If the seal fails, there is an increased risk of infection when the product is used.

    Product
    SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0022-2026·2025-10-08

    Medical Catheter Recalled for Potential Sterile Barrier Packaging Breaches

    Northeast Scientific is recalling 795 units of the NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging that could compromise device sterility.

    Product
    NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2025·2025-07-30

    Medline Convenience Kits Recalled for Potential Sterility Breach Risk

    Medline Convenience Kits containing BD ChloraPrep Clear applicators are recalled due to potential open seals on packaging that may compromise sterility and lead to infection risk during surgical procedures.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2153-2025·2025-07-30

    Medline Convenience Kits with BD ChloraPrep recalled due to sterility breach risk

    Medline Convenience Kits containing BD ChloraPrep applicators are being recalled due to potential open seals that could breach sterility and increase infection risk. The recall affects 960 units distributed in California, Florida, Pennsylvania, and Texas.

    Product
    Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1470-2025·2025-04-09

    Nasopore nasal dressing may have compromised sterile packaging

    Stryker is recalling Nasopore Standard 4cm nasal dressings because the blister seals may develop bubbles, potentially compromising the sterility barrier. Affected units should not be used.

    Product
    Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2025·2025-04-09

    Nasopore Nasal Dressing Recall Due to Compromised Sterile Packaging Seals

    Stryker Corporation is recalling Nasopore nasal dressings due to potentially compromised sterile packaging seals. Affected units totaling 182,344 may have lost sterility, posing a contamination risk.

    Product
    Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
    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-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-1475-2025·2025-04-09

    Otopore Square Outer Ear Wound Dressing Recall for Sterility Seal Defect

    Stryker Corporation is recalling Otopore Square outer ear wound dressings nationwide because sterile packaging seals may develop bubbles, indicating a potential breach of the sterile barrier. Consumers should stop using affected units and contact their healthcare provider.

    Product
    Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2025·2025-04-09

    Nasopore Nasal Dressings Recalled Due to Breached Sterility Seals

    Stryker Corporation is recalling Nasopore nasal dressings due to potential breaches in packaging sterility seals that could compromise product sterilization. Approximately 182,344 units have been distributed nationwide.

    Product
    Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S
    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-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 (Devices)·Z-1482-2025·2025-04-09

    Stryker nasal wound dressing recalled for defective sterile packaging seal

    Stryker Corporation is recalling 182,344 units of Hemopore 2PK nasal/sinus wound dressing due to potential bubbles in blister seals that indicate sterility breach. Affected lot numbers are 2024020221, 2024051720, and 2024082321.

    Product
    Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2025·2025-03-26

    Surgical Drape Packs Recalled for Potential Sterility Breach in Packaging

    Medline Industries is recalling Proxima Sterile Surgical Drape packs due to a potential breach in the pouch packaging that could lead to loss of sterility. The recall affects 1,490 units distributed nationwide.

    Product
    Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,UNIVERSAL II,SIRUS,7/CS; PACK,LAPAROTOMY,NO GOWN,10/CS; PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2025·2025-02-12

    FDA Recalls PROLENE Polypropylene Sutures for Defective Packaging Seals

    Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.

    Product
    PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
    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-1097-2025·2025-02-12

    PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach

    Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.

    Product
    PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2025·2025-01-08

    Rigid Intracardiac Sucker Units Recalled for Potential Sterility Breach

    Med Michigan Holding recalls SUC-4300S Rigid Intracardiac Suckers due to incomplete or partial pouch seals that may compromise sterility during cardiac surgery.

    Product
    SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0759-2025·2025-01-01

    Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk

    Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.

    Product
    ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2025·2025-01-01

    Sterile Magill Forceps Recalled Due to Weak Seals and Contamination Risk

    Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.

    Product
    STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2025·2025-01-01

    RUMMELL Medline Medical Device Weak Seals Sterility Risk Recall

    Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.

    Product
    RUMMELL, Medline Item No. ST006ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2025·2025-01-01

    Sterile Kelly Hemostat Recalled Due to Weak Seals

    Medline's STERILE STRT KELLY HEMOSTAT (SK8039S) is being recalled due to weak seals that could compromise sterility, increasing the risk of contamination and infection. The recall affects 21,440 units distributed nationwide.

    Product
    STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
    Category
    Medical Device
    Distribution
    Distributed nationwide