The Recall Desk

Hazard

Contamination Risk recalls

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

What the numbers show

Total
993
Critical
2
Severe
112
Most recent
2026-08-12

Of the 993 contamination risk recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 112 (11%) 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 contamination risk 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.

51–75 of 993

  • HighFDA (Devices)·Z-1887-2025·2025-06-11

    Palindrome Precision SI Chronic Hemodialysis Catheter Sterile Barrier Recall

    Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack) due to a potential breach of sterile barrier packaging. Approximately 95,938 units distributed nationwide and in Canada and Mexico are affected.

    Product
    Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0420-2025·2025-05-21

    Testosterone Cypionate Injection 200 mg/mL Recalled for Sterility Assurance

    Empower Pharmacy is recalling Testosterone Cypionate Injection 200 mg/mL (Lot 202364, 8,230 vials) distributed nationwide because the manufacturer cannot assure the product's sterility. Consumers should stop using the product and consult their healthcare provider.

    Product
    Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1750-2025·2025-05-21

    TufTex Over-the-Wire Embolectomy Catheter incomplete sterile barrier

    LeMaitre Vascular is recalling TufTex Over-the-Wire Embolectomy Catheters due to incomplete seals on some packages that compromise the sterile barrier. Affected units were distributed nationwide and internationally.

    Product
    TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64, 1651-68, 1651-78, 1651-84, 1651-88, E1651-34, E1651-38, E1651-44, E1651-48, E1651-64, E1651-68, E1651-78, E1651-84, E1651-88, 1651-44J, 1651-48J, 1651-84J, 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2025·2025-05-21

    Centurion Sterile Weitlaner Retractor recalled for sterile packaging puncture risk

    Medline Industries is recalling Centurion Sterile Weitlaner Retractor 3 x 4 Prong units because the retractors may puncture through the sterile packaging. The product is distributed nationwide.

    Product
    Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1751-2025·2025-05-21

    Pruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals

    LeMaitre Vascular is recalling Pruitt Occlusion Catheters (catalog numbers 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56) because some packages have incomplete sterile barrier seals, potentially compromising product sterility.

    Product
    Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2025·2025-05-14

    B Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall

    Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Catalog Number 612802, Model BCL-100-04, Lot S25128171) due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.

    Product
    B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2025·2025-05-14

    Introducer Needle REF NDL-107-04 Sterile Packaging Recall

    Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 due to potential open seals in sterile barrier packaging, which could compromise product sterility.

    Product
    Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2025·2025-05-14

    Galt Medical Introducer Kit Coaxial Dilator recalled for packaging seal issue

    Galt Medical Corporation is recalling certain Introducer Kit–Coaxial Dilator models due to potential open seals in sterile barrier packaging, which could compromise sterility.

    Product
    Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2025·2025-05-07

    Nicardipine Hydrochloride Injection Recalled for Potential Sterility Loss

    American Regent, Inc. is recalling certain lots of Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects 7,249 cartons distributed nationwide.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1707-2025·2025-05-07

    Medline procedure kits recalled for leaking sterile water and saline bottles

    Medline procedure kits containing sterile water and 0.9% normal saline bottles are being recalled because the bottles leak at the peel-foil and bottle opening interface. The kits were distributed worldwide including the US, Panama, and Canada.

    Product
    Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0373-2025·2025-04-30

    Ketamine HCl Syringes Recalled for Lack of Sterility Assurance

    Denver Solutions, LLC is recalling Ketamine HCl 50mg per 5mL single-dose syringes nationwide due to leaking or damaged syringes that may lack sterility assurance. Two affected lots are identified with expiration dates in July 2025.

    Product
    Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0374-2025·2025-04-30

    Rocuronium Bromide Syringes Recalled Due to Sterility Assurance Risk

    Denver Solutions, LLC DBA Leiters Health is recalling Rocuronium Bromide 50 mg per 5mL syringes due to potential leaking or damage that may compromise sterility assurance.

    Product
    Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0370-2025·2025-04-30

    Glycopyrrolate 1mg/5mL Syringes Recalled for Sterility Risk

    Denver Solutions, LLC (DBA Leiters Health) is recalling Glycopyrrolate 1mg/5mL single-dose syringes (Lot #2431015B, expiration 4/10/2025) distributed nationwide because some syringes were found to be leaking or damaged, which compromises sterility assurance.

    Product
    Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0727-2025·2025-04-30

    Texas Olive Company Capers Capote recalled due to contamination risk

    Texas Olive Company Capers Capote in 8 oz. plastic containers and 16 oz. glass jars is being recalled because the repacking and sealing methods pose a possible risk of contamination.

    Product
    Texas Olive Company Capers Capote 8 oz. plastic containers. All lots with expiry prior to 06/04/2025 Texas Olive Company Capers Capote 16 oz. glass jar. All lots with expiry prior to 12/21/2025
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1525-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for lack of sterility assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 2210-5) because they lack adequate sterility assurance. The recall affects approximately 2,080 units distributed worldwide, including across most US states and several countries.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1522-2025·2025-04-23

    Ballard Closed Suction Catheters recalled for lack of sterility assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 210, 10 F Elbow) for neonates and pediatric patients due to lack of sterility assurance. Approximately 4,000 units were distributed worldwide.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1523-2025·2025-04-23

    Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance

    Avanos Medical is recalling Ballard Closed Suction Catheters (Model 20083) due to lack of sterility assurance. The company has distributed approximately 9,960 units worldwide.

    Product
    Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow Component: N/A
    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-1611-2025·2025-04-23

    Medline Convenience Kits for Obstetrical Procedures Recalled for Weak Seals

    Medline Industries is recalling 21,935 units of sterile convenience kits used for labor, delivery, and vaginal delivery procedures due to potential open or weak seals on breather pouches. The defective packaging could compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1532-2025·2025-04-16

    Omnicell IVX Station Reconstitution Transfer Sets Recall

    Omnicell is recalling IVX Station Reconstitution Transfer Sets (Model 298921215) that were shipped in an unvalidated packaging configuration and cannot be assured to be sterile. The devices were intended only for engineering use during setup and system calibration, not clinical use.

    Product
    IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. I
    Category
    Medical Device
    Distribution
    1 state
  • 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-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-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-1474-2025·2025-04-09

    Nasopore nasal dressing recall: compromised sterile barrier seals

    Stryker recalls Nasopore 4cm fragmentable nasal dressings due to potential blister seal damage that compromises the sterile barrier. Nationwide distribution affected.

    Product
    Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2025·2025-04-09

    Otopore Cylinder Wound Dressing Recalled for Potential Sterility Seal Defect

    Stryker Corporation recalls Otopore Cylinder outer ear wound dressing due to potential bubbles in blister seals that may breach the sterile barrier. Affected units were distributed nationwide.

    Product
    Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
    Category
    Medical Device
    Distribution
    Distributed nationwide