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.

1851–1875 of 3429

  • ModerateFDA (Drugs)·D-0296-2018·2018-02-07

    Medline Recalls Subpotent Povidone-Iodine Catheter Insertion Trays

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

    Product
    Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2018·2018-02-07

    Medline Skin Biopsy Pack Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling Skin Biopsy Packs because the iodine concentration is below the label claim.

    Product
    Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline Industries, Inc., Northfield, IL 60093
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0315-2018·2018-02-07

    Medline Incision Drainage Tray Recalled for Subpotent Iodine Concentration

    Medline Industries is recalling specific lots of Incision Drainage Trays because the iodine concentration is below the label claim.

    Product
    Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2018·2018-01-24

    Owen Mumford Recalls Unifine Pentips Due to Potential Sterility Compromise

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Users should check for discoloration or yellowing of the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2018·2018-01-24

    Owen Mumford Recalls Unifine Pentips Pen Needles Due to Sterility Concerns

    Owen Mumford USA is recalling Unifine Pentips pen needles because water exposure may have compromised sterility. Consumers should check for discoloration on the protective seal.

    Product
    Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2018·2018-01-17

    Repro-Med Systems Recalls Freedom60 Precision Flow Rate Tubing Sets

    Repro-Med Systems is recalling Freedom60 Precision Flow Rate Tubing Sets and related needle sets because gaps were found in the sterile barrier packaging during inspection.

    Product
    Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2018·2017-11-29

    Halyard Closed Suction System Recalled for Potential Saline Vial Leaks

    Halyard Health is recalling specific lots of Closed Suction Systems because the saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0122-2018·2017-11-29

    Halyard Closed Suction System Recalled Due to Saline Vial Leaking Risk

    Halyard Health is recalling specific lots of Closed Suction Systems because 15ml saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0075-2018·2017-11-15

    Terumo BCT Recalls Harvest Graft Delivery Packs Due to Seal Defect

    Terumo BCT is recalling 525 Harvest Graft Delivery Packs because some lots may lack a seal on the inner pouch, potentially compromising sterility.

    Product
    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the si
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2018·2017-11-15

    Epimed Recalls TUOHY Epidural Needles Due to Potential Sterility Seal Issues

    Epimed International is recalling 263 units of TUOHY Epidural Needles because a partially incomplete seal could impact the product's sterility.

    Product
    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0065-2018·2017-11-08

    SCA Pharmaceuticals Recalls Oxytocin Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 450 bags of oxyTOCIN 30 units in Lactated Ringers due to a lack of assurance of sterility.

    Product
    oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0059-2018·2017-11-08

    SCA Pharmaceuticals Recalls Succinylcholine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,248 syringes of Succinylcholine 20 mg/mL due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUCcinylcholine 200 mg / 10 ml) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0910-29
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0024-2018·2017-11-01

    Banner Pharmacy Recalls Ropivacaine HCL Cassettes Due to Sterility Concerns

    Banner Pharmacy Services is recalling Ropivacaine HCL cassettes because the FDA determined there is a lack of assurance of sterility.

    Product
    Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226 NDC 7025006301
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1167-2017·2017-09-27

    Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns

    Pfizer is recalling 115,370 vials of Hydromorphone Hydrochloride Injection because a damaged sterilizing filter may have compromised sterility assurance during manufacturing.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1158-2017·2017-09-20

    Bella Pharmaceuticals Recalls Sodium Bicarbonate Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling specific lots of Sodium Bicarbonate 8.4% vials because the company cannot ensure the product is sterile.

    Product
    Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1151-2017·2017-09-20

    Bella Pharmaceuticals Recalls B-Complex Vials Due to Sterility Concerns

    Bella Pharmaceuticals is recalling 45 vials of B-Complex due to a lack of assurance of sterility. The affected lot is BPBC3080517, expiring 2/5/18.

    Product
    B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3078-2017·2017-09-06

    Certified Safety Mfg Recalls Sterile Burn Sheets for Shredding Risk

    Certified Safety Mfg Inc is recalling sterile burn sheets included in first aid kits because they may shred, potentially failing to protect patients from infection.

    Product
    Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3063-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans Filtron 1000 Due to Seal Integrity

    Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 1000 because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3065-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans MEGA 1500 Due to Seal Integrity

    Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 devices because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3060-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans Filtron 100 Due to Seal Integrity

    Shippert Medical Technologies is recalling Tissu-Trans Filtron 100 units because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3068-2017·2017-08-30

    Pentax Ultrasound Video Gastroscope Recall Due to Instruction Error

    Pentax of America Inc is recalling 116 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.

    Product
    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2872-2017·2017-08-16

    C.R. Bard Recalls Leg Bags Due to Potential Sterile Barrier Breach

    C.R. Bard is recalling 2,350 units of Bard Dispoz-A-Bag leg bags due to a reported cut in the side that may compromise the sterile barrier.

    Product
    BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2792-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2789-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterility Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide