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.

1601–1625 of 3429

  • HighFDA (Devices)·Z-1584-2019·2019-06-05

    Maquet Getinge ROTAFLOW Support Pack Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling ROTAFLOW Support Packs because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2019·2019-06-05

    Maquet Getinge Infant ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific infant extracorporeal circulation tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of custom tubing sets for extracorporeal circulation because the design may prevent proper sterilization gas flow.

    Product
    Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1550-2019·2019-06-05

    Maquet Getinge Neonatal Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific neonatal tubing sets because a design feature may prevent sterilization gas from reaching all parts, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2019·2019-06-05

    Maquet Small Patient Tubing Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific Small Patient Tubing Packs because a design flaw may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1567-2019·2019-06-05

    Maquet Getinge Pediatric ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific pediatric extracorporeal circulation tubing sets because the stopcock design may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2019·2019-06-05

    Maquet Getinge Cardioplegia Packs Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific batches of Getinge-BO-T 52360 Cardioplegia Packs because a design feature may prevent proper sterilization of the stopcock ports.

    Product
    Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled for Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2019·2019-06-05

    Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific ECC tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1587-2019·2019-06-05

    Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns

    Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.

    Product
    Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2019·2019-05-29

    Dornier Diode Laser Fibers Recalled for Sterility Compromise

    Dornier Medtech America is recalling 400 units of Dornier Diode Laser Fibers due to pin hole package failures that compromise product sterility.

    Product
    Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1335-2019·2019-05-22

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

    Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 sterile pouches because a cut or hole may compromise sterility.

    Product
    Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2019·2019-05-22

    Shippert Medical Technologies Recalls Tissu-Trans Syringe Fill 360 Due to Pouch Integrity Concerns

    Shippert Medical Technologies is recalling Tissu-Trans Syringe Fill 360 devices because the sterile pouch integrity cannot be assured without visual examination.

    Product
    Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems because voids or partial seals may compromise sterility. The recall covers units distributed worldwide.

    Product
    ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Sterility Seal Defects

    ConMed is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall covers 5,034 units distributed worldwide.

    Product
    ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1309-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    Conmed Corporation is recalling Anchor Tissue Retrieval Systems due to seal defects that may compromise sterility. The recall affects 7,930 units distributed in the US and 13 other countries.

    Product
    ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity duri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2019·2019-05-15

    ConMed Anchor Tissue Retrieval System Recalled for Seal Defects

    Conmed Corporation is recalling specific lots of the Anchor Tissue Retrieval System because seal defects may compromise the product's sterility.

    Product
    ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1255-2019·2019-05-08

    Customceutical Compounding Recalls Glutathione Injection Vials Due to Sterility Concerns

    Customceutical Compounding is recalling specific lots of compounded Glutathione 200mg/mL injection vials because the FDA could not ensure the products were sterile.

    Product
    Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2019·2019-05-01

    Stryker Performance Series Sagittal Blade Recall for Sterility Breach

    Stryker is recalling 355 Performance Series Sagittal Blades due to a potential breach in sterility caused by improper packaging positioning during manufacture.

    Product
    Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compart
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1128-2019·2019-04-24

    MSM Red Eye Eye Drops Recalled for Sterility Assurance Issues

    MSM Nutraceuticals is recalling Red Eye Eye Drops because the product lacks assurance of sterility and was not tested per USP 71.

    Product
    Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1136-2019·2019-04-24

    FDA Recalls Volumex Injection Due to Sterility Concerns

    Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results indicate sterility cannot be assured.

    Product
    VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1086-2019·2019-04-17

    FDA Recalls Compounded Sodium Chloride Eye Drops Due to Insanitary Conditions

    The FDA is recalling compounded sodium chloride eye drops from Professional Compounding Pharmacy in Oregon due to insanitary conditions observed during compounding.

    Product
    SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1104-2019·2019-04-17

    FDA Recalls Compounded Injectable Drug Due to Insanitary Compounding Conditions

    Professional Compounding Pharmacy is recalling Papaverine-Phentolamine-PGE1 injectable due to insanitary conditions observed during compounding.

    Product
    PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
    Category
    Drug
    Distribution
    1 state