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.

1026–1050 of 2518

  • SevereFDA (Drugs)·D-0763-2017·2017-05-24

    Key Pharmacy Recalls Ferric Gluconate Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Ferric Gluconate Injection because the firm cannot guarantee the sterility of the compounded drug.

    Product
    FERR GLUC MDV 60MG/ML INJ, Injection, 60mg/mL, Rx only, Packaged in 5mL and 10mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0718-2017·2017-05-24

    Key Pharmacy Recalls Folinic Acid Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid injections because the firm cannot guarantee the products are sterile.

    Product
    FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0711-2017·2017-05-24

    Key Pharmacy Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Atropine Sulfate 0.01% Ophthalmic Solution because the firm cannot assure the sterility of the product.

    Product
    ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0742-2017·2017-05-24

    Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 25 vials of TRI MIX 20/20/1 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0784-2017·2017-05-24

    Key Pharmacy Recalls Vitamin B Complex Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of Vitamin B Complex injections because the firm cannot guarantee the products are sterile.

    Product
    VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0717-2017·2017-05-24

    Key Pharmacy Recalls Folic Acid Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 10mg/mL injection due to a lack of assurance of sterility.

    Product
    FOLIC ACID 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0746-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.

    Product
    TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0744-2017·2017-05-24

    Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 20/30/1 injection due to a lack of assurance of sterility.

    Product
    TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2017·2017-05-24

    Medline 14 mm Distraction Pin Recalled for Potential Sterility Loss

    Medline Industries is recalling 14 mm Distraction Pins due to potential sterile packaging seal failures that could compromise device sterility.

    Product
    14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0708-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL multiple-dose vials due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2050-2017·2017-05-17

    Mederi Stretta Catheter Recalled Due to Sterility Compromise

    Mederi Therapeutics is recalling 1,458 Stretta Catheter kits because a breach in the sterile barrier package compromised sterility.

    Product
    Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0685-2017·2017-05-03

    Isomeric Pharmacy Recalls Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 851 vials of a multi-dose injection product because production processes cannot assure sterility.

    Product
    Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0681-2017·2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 4,001 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0686-2017·2017-05-03

    Isomeric Pharmacy Recalls Testosterone Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,156 vials of Testosterone Cypionate and Propionate injection due to production processes that cannot assure sterility.

    Product
    Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2017·2017-04-26

    NAMIC Fluid Delivery Set Recalled for Potential Non-Sterility

    Angiodynamics Inc. is recalling NAMIC Fluid Delivery Sets because they may not be sterile due to packaging errors.

    Product
    NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1758-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 Accessory Packages with Non-Sterile Sheaths

    ConMed is recalling Hyfrecator 2000 accessory packages because they contained non-sterile handpiece sheaths labeled as sterile.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units --- ASSEMBLE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1757-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 ESU Cartons with Non-Sterile Handpiece Sheaths

    ConMed is recalling Hyfrecator 2000 ESU cartons because they were packaged with non-sterile handpiece sheaths labeled as sterile, posing a risk of infection.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2017·2017-04-19

    Roche Recalls Cobas 8100 Reformatter Modules Due to Rack Crash Risk

    Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a rack crash can cause sample spillage, posing a risk of exposure to infectious material.

    Product
    Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1760-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 Handpiece Sheaths Due to Sterility Labeling Error

    ConMed is recalling Hyfrecator 2000 handpiece sheaths because non-sterile units were packaged in pouches labeled as sterile, posing a risk of infection.

    Product
    HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1745-2017·2017-04-12

    Recall of Curity Saline Dressings Due to Compromised Sterility

    Covidien LLC is recalling Curity Saline Dressings because the sterile barrier was breached, compromising sterility. The recall covers lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debrideme
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1744-2017·2017-04-12

    Recall of Curity Sodium Chloride Dressings Due to Sterility Compromise

    Covidien LLC is recalling Curity Sodium Chloride Dressings because the sterile barrier is breached, compromising sterility. The recall affects lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1739-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2017·2017-04-12

    Sterile Saline Dressing Recalled Due to Compromised Sterility Barrier

    FDA is recalling Kerlix Super Sponge Saline Dressings because the sterile barrier is breached, potentially compromising sterility.

    Product
    Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1724-2017·2017-04-05

    Sammy's Milk Baby Food Recalled for Cronobacter Bacteria

    Sammy's Milk is recalling specific lots of baby food due to possible Cronobacter bacteria and inadequate iron levels.

    Product
    Sammy's Milk (Baby Food), Net Wt. 12.84 oz (364 g), 6 containers per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1630-2017·2017-04-05

    FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 236 robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
    Category
    Medical Device
    Distribution
    2 states