The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 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 993 (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.

2501–2525 of 3438

  • ModerateFDA (Devices)·Z-0855-2016·2016-03-02

    Stryker Vitallium Wire Recalled Due to Sterilization Labeling Error

    Stryker is recalling Vitallium Wire because the instructions incorrectly state the non-sterile device is sterile, omitting required sterilization steps.

    Product
    Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0692-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit size; refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0706-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns regarding the assurance of sterility.

    Product
    papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0680-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Folic Acid Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of compounded Folic Acid, 10 mg/mL, after an FDA inspection identified concerns regarding the assurance of sterility.

    Product
    Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0688-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Papaverine Prostaglandin Due to Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of papaverine prostaglandin 30 mg/30 mcg/mL in California due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0703-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0712-2016·2016-02-24

    Abbott's Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Concerns

    Abbott's Compounding Pharmacy is recalling all unexpired lots of sterile compounded products, including papaverine phentolamine prostaglandin, due to FDA inspection findings regarding lack of sterility assurance.

    Product
    papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0620-2016·2016-02-03

    Sentara Recalls Dextrose-NaCl Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling specific lots of Dextrose-NaCl (D5-1/2NS) in Homepumps because product sterility cannot be guaranteed.

    Product
    Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0614-2016·2016-02-03

    Sentara Parenteral Amino Acid Infusion Recalled for Sterility Concerns

    Sentara Enterprises is recalling Parenteral Amino Acid Infusion 10% bags because product sterility cannot be guaranteed. The recall affects specific lots compounded in September 2015.

    Product
    Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps…
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0623-2016·2016-02-03

    Sentara Recalls Vancomycin HCL Homepumps Due to Sterility Concerns

    Sentara Enterprises is recalling Vancomycin HCL home infusion bags because the product's sterility cannot be guaranteed. The recall affects bags distributed in Virginia and North Carolina.

    Product
    VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML…
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0640-2016·2016-02-03

    Sentara Recalls Solu-Cortef Syringes Due to Sterility Concerns

    Sentara Enterprises is recalling 9 bags of Solu-Cortef (hydrocortisone) 1MG in NS syringes because product sterility cannot be guaranteed. The affected lots were compounded in September 2015 and distributed in Virginia and North Carolina.

    Product
    Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0618-2016·2016-02-03

    Sentara Recalls Intralipid Fat Emulsion Due to Sterility Assurance Issues

    Sentara Enterprises is recalling specific lots of Intralipid fat emulsion because the product's sterility cannot be guaranteed. The affected bags were distributed in Virginia and North Carolina.

    Product
    INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0585-2016·2016-01-27

    Mylan Bromfenac Ophthalmic Solution Recalled for Sterility Assurance Failure

    Mylan Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because the preservative failed an effectiveness test, raising concerns about sterility.

    Product
    Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2016·2016-01-27

    Abeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise

    Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0684-2016·2016-01-27

    Abeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise

    Abeon Medical Corporation is recalling 2,570 units of the TLC Self Retaining Retractor System because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2016·2016-01-27

    Abeon Wilson Penile Implantation System Retractor Frame Recalled for Sterility Compromise

    Abeon Medical Corporation is recalling Wilson Penile Implantation System Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0544-2016·2016-01-06

    Walgreens Recalls Sodium Ascorbate Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling compounded Sodium Ascorbate (Vitamin C) syringes in Texas due to a lack of assurance of sterility.

    Product
    Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0556-2016·2016-01-06

    Walgreens Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 43 bags of 0.9% Sodium Chloride injection in Texas due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0527-2016·2016-01-06

    Walgreens Recalls Heparin Injection Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 49 syringes of Heparin injection, Preservative Free, due to a lack of assurance of sterility. The affected products were distributed in Texas.

    Product
    Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0475-2016·2015-12-30

    Arthrosurface Total Toe Instrument Kit Recalled for Sterilization Failure

    Arthrosurface is recalling 3 Total Toe Instrument Kits because a hex driver component failed to pass half-cycle sterilization due to a design oversight.

    Product
    Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0470-2016·2015-12-30

    Hardy Diagnostics Recalls FB Broth Due to Potential Contamination

    Hardy Diagnostics is recalling FB Broth (Lot 15231) because of potential Burkholderia fungorum contamination. The product was distributed in California, Wisconsin, Maryland, and Utah.

    Product
    FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0416-2016·2015-12-23

    Cook Medical Recalls VentriClear II Catheters Due to Sterilization Error

    Cook Medical is recalling specific lots of VentriClear II Ventricular Drainage Catheter Sets because double sterilization may reduce the antibiotic coating below labeled levels.

    Product
    VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0382-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0453-2016·2015-12-09

    Western Drug Recalls Squaric Acid 4% Injection Due to Sterility Concerns

    Western Drug is recalling Squaric Acid 4% Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Squaric Acid 4% Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2016·2015-12-09

    Western Drug Recalls Tacrolimus Eye Drops Due to Sterility Concerns

    Western Drug is recalling two containers of Tacrolimus 0.02% Opth Sol due to a lack of assurance of sterility. The product was distributed nationwide in eight states.

    Product
    Tacrolimus 0.02% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide