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.

2351–2375 of 3429

  • SevereFDA (Drugs)·D-1542-2016·2016-10-05

    FDA Recalls Pre-Op Pledget Ophthalmic Drops Due to Sterility Concerns

    Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln ophthalmic drops due to a lack of assurance of sterility. The recall affects 6 vials distributed in Mississippi.

    Product
    Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1514-2016·2016-09-28

    Sandoz Recalls Phenylephrine Injection Due to Sterility Concerns

    Sandoz Inc. is recalling specific lots of Phenylephrine HCI Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1513-2016·2016-09-28

    Sandoz Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Sandoz Inc. is recalling specific lots of Ephedrine Sulfate Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2848-2016·2016-09-28

    Smith & Nephew Recalls Renasys Sterile Transparent Film Due to Seal Failures

    Smith & Nephew is recalling Renasys Sterile Transparent Film and related dressing kits because sterility seal integrity failures may compromise the sterile barrier.

    Product
    RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2830-2016·2016-09-21

    C.R. Bard Recalls Option-vf Urinary Catheters Due to Sterility Concerns

    C.R. Bard is recalling 274 units of Option-vf Urinary Catheters because an FDA inspection found them to be potentially nonsterile.

    Product
    Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2751-2016·2016-09-14

    Biomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency

    Biomet Microfixation is recalling 54 custom-made Hard Tissue Replacement implants due to a potential sterility deficiency. The affected units were distributed in the US and internationally.

    Product
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2745-2016·2016-09-14

    Smith & Nephew Whipknot Soft Tissue Cinch Suture Recalled for Sterility Breach

    Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because sterile packaging was breached, compromising sterility. The recall covers 34,065 units distributed worldwide.

    Product
    Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2761-2016·2016-09-14

    Riverpoint Medical Recalls Nylon Surgical Sutures Due to Seal Integrity Issues

    Riverpoint Medical is recalling sterile nylon surgical sutures because the seals may become open during distribution or packaging.

    Product
    Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, oph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2743-2016·2016-09-14

    Integra Recalls Achillon Suture System Due to Sterility Concerns

    Integra LifeSciences is recalling the Achillon Suture System because internal studies suggest the secondary package seal may not maintain intended sterility.

    Product
    Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2687-2016·2016-09-07

    Baxter Non-DEHP Micro-Volume Extension Set Recalled for Sterility Compromise

    Baxter Healthcare is recalling 15,257 units of Non-DEHP Micro-Volume Extension Sets because improper sealing compromised product sterility.

    Product
    Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2705-2016·2016-09-07

    Medical Vision Ab Recalls Double Pump RF Patient Cassettes

    Medical Vision Ab is recalling 3,295 Double Pump RF Patient Cassettes because sterile package breakage may compromise device sterility.

    Product
    Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2577-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrode Due to Sterile Barrier Compromise Risk

    Medtronic is recalling 3,470 Valleylab Laparoscopic Flat L-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall affects 6,381 units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a sing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2572-2016·2016-08-24

    Medtronic Recalls Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling 1,440 Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and sucti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 19,200 Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2213-2016·2016-07-27

    AMD-RITMED Conforming Stretch Gauze Bandages Recalled for Sterility Failure

    AMD-RITMED is recalling specific lots of sterile conforming stretch gauze bandages because FDA testing showed they did not meet sterility requirements.

    Product
    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawa
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1180-2016·2016-07-20

    Medaus Recalls DMPS 50mg/mL Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling DMPS 50mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.

    Product
    DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1195-2106·2016-07-20

    Medaus Recalls L-Carnitine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling L-Carnitine 50mg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.

    Product
    L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1281-2016·2016-07-20

    Pharmakon Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 25 units of Morphine Sulfate syringes because the company cannot guarantee the products are sterile.

    Product
    Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1253-2016·2016-07-20

    Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Zinc Sulfate 1mg/mL vials because the company cannot ensure the product is sterile.

    Product
    ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1188-2016·2016-07-20

    Medaus Recalls Hyaluronidase Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Hyaluronidase 500U/ML vials because the company cannot assure the sterility of the product. The recall affects lots distributed in the U.S., Japan, and New Zealand.

    Product
    HYALURONIDASE 500U/ML(PF), 3ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide