The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 988 (29%) 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 infection 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.

1801–1825 of 3429

  • HighFDA (Devices)·Z-1325-2018·2018-04-18

    Arrow International Recalls Two-Lumen PICC Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of two-lumen PICC kits because the catheters may not be completely sealed, potentially compromising sterility.

    Product
    Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1309-2018·2018-04-11

    C.R. Bard Recalls Personal Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling Personal Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

    Product
    Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G, 53612
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2018·2018-04-11

    C.R. Bard Recalls HydroSil Gripper Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling specific lots of HydroSil Gripper Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.

    Product
    HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1247-2018·2018-04-04

    Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns

    Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1252-2018·2018-04-04

    Stryker Recalls Orthopedic Cement Mixers Due to Sterility Assurance Issues

    Stryker is recalling 732 units of Revolution CMS orthopedic cement mixers because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

    Product
    Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0982-2018·2018-03-21

    Alden Optical Recalls NovaKone Toric Contact Lenses for Sterility Issues

    Alden Optical is recalling 33 units of NovaKone Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.

    Product
    NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not ap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0988-2018·2018-03-21

    Alden HP54 Toric Contact Lenses Recalled for Sterility Assurance Issues

    Alden Optical is recalling HP54 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0837-2018·2018-03-14

    Stryker Recalls ACL Interface Screws Due to Bioburden Levels

    Stryker is recalling specific lots of ACL Interface Screws because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0906-2018·2018-03-14

    Synthes Recalls 2.5 mm Titanium Calibrated Reaming Rods Due to Sterility Concerns

    Synthes (USA) Products LLC is recalling 63 units of 2.5 mm Titanium Calibrated Reaming Rods because potential gaps in the package seal may have compromised product sterility.

    Product
    2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 960 sterile 3.0 mm Reaming Rods because package seal defects may compromise sterility.

    Product
    3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2018·2018-03-14

    Synthes 2.5 mm Guide Rods Recalled for Potential Sterility Loss

    Synthes (USA) Products LLC is recalling 21 sterile 2.5 mm Guide Rods due to potential package seal defects that may compromise sterility.

    Product
    2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 2.5 mm Reaming Rods because package seal defects may have compromised sterility. The devices are used in orthopedic surgery.

    Product
    2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2018·2018-03-14

    Synthes Recalls 2.5 mm Reaming Rods Due to Potential Sterility Loss

    Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods because package seal defects may have compromised sterility.

    Product
    2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2018·2018-03-14

    Medtronic BIO CAL Temperature Controller Recalled Due to Cleaning Protocol Issues

    Medtronic is recalling BIO CAL Temperature Controllers because it cannot develop a cleaning protocol that meets current industry standards. Users are advised to discontinue use and dispose of the devices.

    Product
    BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0903-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise sterility.

    Product
    2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2018·2018-03-14

    Stryker Recalls StrykeFlow 2 System Due to Bioburden Testing Results

    Stryker is recalling 60,753 units of the StrykeFlow 2 System because routine bioburden testing found levels higher than internal acceptable rates.

    Product
    StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRI
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0838-2018·2018-03-14

    Stryker Recalls ACL Disposable Packs Due to Bioburden Levels

    Stryker is recalling ACL Disposable Pack Bone-Tendon-Bone units because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0467-2018·2018-02-28

    Pharmedium Recalls Rocuronium Bromide Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all Rocuronium Bromide products due to a lack of sterility assurance. The recall covers all strengths, doses, and packaging nationwide.

    Product
    Rocuronium Bromide in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2018·2018-02-28

    Medtronic Recalls Affinity NT Cardiotomy Reservoirs Due to Sterile Barrier Breach

    Medtronic is recalling Affinity NT Cardiotomy/Venous Reservoirs because of a possible sterile barrier breach in the pouch.

    Product
    Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed whi
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0646-2018·2018-02-28

    Medtronic Cardiotomy Reservoir Recall for Possible Sterile Barrier Breach

    Medtronic is recalling Affinity NT Cardiotomy Venous Reservoirs due to a possible sterile barrier breach in the pouch.

    Product
    Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0534-2018·2018-02-14

    Medtronic Recalls Vistec X-Ray Detectable Sponges Due to Blood Contamination

    Medtronic is voluntarily recalling two lots of Vistec X-Ray Detectable Sponges due to possible contamination with human blood during manufacturing.

    Product
    Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0288-2018·2018-02-07

    Medline Suture Removal Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0273-2018·2018-02-07

    Medline Dressing Change Tray Kit Recalled for Subpotent Iodine Content

    Medline Industries is recalling Dressing Change Tray Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.

    Product
    Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0276-2018·2018-02-07

    Medline Catheter Insertion Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling sterile catheter insertion kits because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0275-2018·2018-02-07

    Medline Circumcision Tray Kit Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Circumcision Tray Kits because the iodine concentration in the prep pads is below the labeled claim.

    Product
    Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide