The Recall Desk

Hazard

Infection recalls

2,518 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,518
Critical
31
Severe
1,671
Most recent
2026-08-26

Of the 2,518 infection recalls we have scored against our rubric, 31 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,671 (66%) 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 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.

301–325 of 2518

  • HighFDA (Devices)·Z-2895-2020·2020-09-02

    Karl Storz Flexible DCI Intubation Fiberscope Recalled for Sterilization Instructions

    Karl Storz Endoscopy is recalling 428 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid incomplete sterilization.

    Product
    Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2897-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz is recalling 380 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid infection.

    Product
    Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2892-2020·2020-09-02

    Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Updates

    Karl Storz Endoscopy is recalling 1,246 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid incomplete sterilization.

    Product
    Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2804-2020·2020-08-19

    Arrow International Recalls NextStep Retrograde Replacement Hub Set Due to Labeling Error

    Arrow International is recalling NextStep Retrograde Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2801-2020·2020-08-19

    Arrow Single Shot Epidural Anesthesia Kit Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling specific lots of Single Shot Epidural Anesthesia Kits because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2802-2020·2020-08-19

    Arrow International Recalls Cannon II Plus Replacement Hub Sets for Labeling Error

    Arrow International Inc is recalling Cannon II Plus Replacement Hub Sets because the lidstock displays an incorrect expiration date, which could lead to the use of expired devices.

    Product
    Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2803-2020·2020-08-19

    Arrow TheraCath Epidural Catheter Recalled for Incorrect Expiration Date

    Arrow International Inc. is recalling TheraCath Epidural Catheters because the lidstock displays an incorrect expiration date, potentially leading to the use of expired devices.

    Product
    Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2668-2020·2020-07-29

    Becton Dickinson SafeStep Huber Needle Set Recall for Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kits due to potential tubing cracks that may cause leakage.

    Product
    SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2660-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

    Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing cracks may cause leakage of chemicals or biohazard materials.

    Product
    PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2664-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, risking leakage of chemicals or blood.

    Product
    SafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2665-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking leakage of chemicals or blood.

    Product
    SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2663-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

    Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking leakage of chemicals or biohazard materials.

    Product
    PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2667-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack, risking chemical exposure, blood loss, or infection.

    Product
    SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2670-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

    Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Sets because tubing may crack or break near the Luer or Y site, risking leakage of chemicals or blood.

    Product
    PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2662-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Port Access Kits

    Becton Dickinson is recalling PowerLoc MAX Power Injectable Infusion Port Access Kits due to potential tubing cracks that may cause leakage of hazardous materials.

    Product
    PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2671-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of chemicals or biohazard materials.

    Product
    SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 0080174106630
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2666-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Set Port Access Kits

    Becton Dickinson is recalling SafeStep Huber Needle Set Port Access Kits because tubing may crack or break, potentially causing leakage of hazardous materials or blood.

    Product
    SafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2669-2020·2020-07-29

    Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

    Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of hazardous chemicals or blood.

    Product
    SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 008
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2661-2020·2020-07-29

    Becton Dickinson Recalls PowerLoc MAX Infusion Sets Due to Tubing Cracks

    Becton Dickinson is recalling PowerLoc MAX infusion sets because tubing may crack, risking chemical exposure, blood loss, or infection.

    Product
    PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (U
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2491-2020·2020-07-15

    Prodimed Combicath Paediatric Catheters Recalled Due to Sterility Assurance Issues

    Prodimed Plastimed Division is recalling 180 units of Combicath Paediatric catheters nationwide because the company cannot assure the sterility of the devices.

    Product
    Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2020·2020-07-15

    Prodimed Combicath Catheters Recalled Due to Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling Combicath catheters for mini bronchoalveolar lavage because of a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2526-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal

    TeDan Surgical Innovations LLC is recalling 1,965 Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile labeling.

    Product
    PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2020·2020-06-17

    Intuitive Surgical Recalls 8mm Endoscope Sterilization Trays Due to Sterility Risk

    Intuitive Surgical is recalling 1,757 stainless steel reprocessing trays because holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2020·2020-06-17

    Intuitive Surgical Recalls IS4000 Sterilization Trays Due to Sterility Breach Risk

    Intuitive Surgical is recalling IS4000 stainless steel reprocessing trays because small holes in the sterilization wrap could compromise sterility and increase infection risk.

    Product
    STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using a minimally invasive approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2020·2020-05-27

    Skeletal Kinetics Recalls Cranio/Sculpt C Bone Void Filler Due to Sterilization Concerns

    Skeletal Kinetics is recalling 125 units of Cranio/Sculpt C bone void filler because one unit may have been mispackaged and not sterilized.

    Product
    Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranial bone defects and craniotomy cuts with a surface area no larger than
    Category
    Medical Device
    Distribution
    Distributed nationwide