The Recall Desk

Hazard

Sterility Compromise recalls

328 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 compromise 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.

76–100 of 328

  • HighFDA (Devices)·Z-1873-2025·2025-06-04

    Umbilical Vessel Catheters Recalled for Sterility-Compromising Packaging Defect

    Cardinal Health is recalling 51,378 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in newborns.

    Product
    Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2025·2025-06-04

    Cardinal Health Umbilical Catheters Recalled for Packaging Sterility Defect

    Cardinal Health is recalling 10,438 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2025·2025-06-04

    Umbilical Catheter Insertion Tray Recall Due to Packaging Defect Risk

    Cardinal Health is recalling 370 units of umbilical vessel catheter insertion trays due to a packaging defect that may compromise sterility, posing infection risk to neonates.

    Product
    Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2025·2025-06-04

    Umbilical Vessel Catheters Recalled Due to Sterility Packaging Defect

    Cardinal Health recalls 1,710 umbilical vessel catheters due to a packaging defect that may compromise sterility. Non-sterile devices could cause infection in newborns.

    Product
    Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2025·2025-06-04

    Umbilical vessel catheter recalled due to packaging sterility defect

    Cardinal Health is recalling 2,280 umbilical vessel catheters due to a packaging defect that may compromise product sterility. Non-sterile catheters could cause infection in neonates.

    Product
    Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2025·2025-06-04

    Orthopedic Implant Components Recalled Due to Potential Tyvek Seal Defects

    Onkos Surgical is recalling 120 units of Segmental Stem components for the ELEOS LIMB SALVAGE SYSTEM due to potential breaches in Tyvek sterile packaging seals that could compromise product sterility.

    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
  • HighFDA (Devices)·Z-1736-2025·2025-05-14

    Introducer Needles Recalled Over Potential Sterile Barrier Packaging Seal Failure

    Galt Medical Corporation is recalling Introducer Needles (REF NDL-107-04, lot 24108670) due to a potential open seal in sterile barrier packaging. Distribution included multiple U.S. states and international locations.

    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-1710-2025·2025-05-07

    Medline Sterile Water and Saline Bottles Recalled Due to Leaking

    Medline Sterile Water and 0.9% Normal Saline bottles may leak at the peel-foil seal, potentially compromising sterility. Units were distributed to the US, Panama, and Canada.

    Product
    Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0398-2025·2025-05-07

    Injectable Drug Recalled for Potential Sterility Issues Due to Product Leakage

    American Regent is recalling Nicardipine Hydrochloride Injection because product leakage around vial necks could compromise sterility. The nationwide recall affects approximately 29,777 cartons; no illnesses have been reported.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2025·2025-05-07

    Medline sterile solution bottles recalled due to leaking seals

    Medline is recalling procedure kits because the sterile water and saline bottles leak at the peel-foil seal. The recall affects 822 units distributed in the US, Panama, and Canada.

    Product
    Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2025·2025-05-07

    Medline I&D Procedure Kits Recalled for Leaking Saline Bottles

    Medline is recalling 240 units of NON STERILE I&D KIT (Lot 23KDB283) distributed in the US, Panama, and Canada. The Sterile Water and Normal Saline bottles in the kits are leaking at the peel-foil interface, compromising sterility.

    Product
    Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0399-2025·2025-05-07

    Injectable nicardipine recalled due to vial leakage and sterility risk

    American Regent is recalling nicardipine hydrochloride injection due to product leakage around vial necks that could compromise sterility. Affected batches were distributed nationwide; healthcare facilities should not use recalled lots.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0374-2025·2025-04-30

    Rocuronium Bromide Syringes Recalled for Sterility Assurance Issue

    Denver Solutions recalls 16,655 Rocuronium Bromide syringes nationwide due to damaged or leaking units that compromise sterility assurance. Lot #2530023 expires 7/12/2025.

    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-0369-2025·2025-04-30

    Injectable Drug Haloperidol Decanoate Recalled for Bacterial Contamination

    Amerisource Health Services LLC recalled Haloperidol Decanoate injection nationwide due to lack of sterility assurance. Bacterial contamination was detected during quality testing of batch A240482B.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2025·2025-04-23

    Medline Sterile Procedure Kits Recalled Due to Weak Breather Pouch Seals

    Medline is recalling sterile convenience kits used for various procedures because breather pouches may have open or weak seals, which could compromise sterility during storage or transport.

    Product
    Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1587-2025·2025-04-23

    Medline Rhinoplasty Convenience Kit Recalled Due to Potential Seal Failures

    Medline is recalling Rhinoplasty Convenience Kits (Model DYNJ84116A, Lot 24IBH580) due to potential open or weak seals on breather pouches. Compromised seals could affect package sterility, though no illnesses have been reported.

    Product
    Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1611-2025·2025-04-23

    Medline Sterile Obstetrical Procedure Kits Recalled for Potential Packaging Seal Defects

    Medline is recalling 21,935 sterile convenience kits used for obstetrical procedures due to potential open or weak seals on breather pouches that could compromise product sterility. The kits were distributed nationwide and internationally.

    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-1604-2025·2025-04-23

    Medline Recalls IV Convenience Kits for Potential Seal Defects

    Medline is recalling 84 IV PACK SOUTH convenience kits due to potential weaknesses in breather pouch seals that may compromise sterility. The affected kits were distributed worldwide including the US, Canada, Mexico, Panama, and the Virgin Islands.

    Product
    Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2025·2025-04-23

    Medline Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Convenience kits (Model SUT15830A, Lot 24IBR642) are recalled due to potential weak or open seals on breather pouches that could compromise sterility. The recall affects units distributed in the US and internationally.

    Product
    Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1530-2025·2025-04-16

    Hydrocolloid Bandage Recall: Potential Sterility Compromise in Multiple Models

    Medline Industries recalls Wayson Hydrocolloid bandages due to potential compromise of device sterility. Approximately 364,842 units across five model numbers are affected.

    Product
    Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1531-2025·2025-04-16

    Wayson Hydrocolloid Bandages Recalled for Potential Sterility Compromise

    Medline Industries is recalling Wayson Hydrocolloid bandages due to potential sterility compromise. Approximately 1.9 million units distributed nationwide and internationally are affected.

    Product
    Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Mode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1532-2025·2025-04-16

    Omnicell IVX Station Reconstitution Transfer Sets recalled for sterility concerns

    Omnicell has recalled 3 IVX Station Reconstitution Transfer Sets (Model 298921215) distributed in Alabama due to improper packing that prevents sterility assurance. The engineering devices were shipped for system setup, 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
    0 states
  • 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