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.

2376–2400 of 3429

  • SevereFDA (Drugs)·D-1198-2016·2016-07-20

    Medaus Recalls L-Glutathione Vials Due to Sterility Concerns

    Medaus, Inc. is recalling L-Glutathione 100mg/mL vials because the product lacks assurance of sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1232-2016·2016-07-20

    Medaus Recalls Procaine 2% Vials Due to Sterility Assurance Concerns

    Medaus, Inc. is recalling Procaine 2% vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.

    Product
    PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1310-2016·2016-07-20

    Pharmakon Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 100 units of compounded Fentanyl and Bupivacaine syringes due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1208-2016·2016-07-20

    Medaus Recalls Lipo-Injection Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the FDA determined there is a lack of assurance of sterility.

    Product
    LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1254-2016·2016-07-20

    Medaus Recalls Hydrochloric Acid Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of HCL 2MG/ML (PF) 5ML Vials because the company cannot ensure the product is sterile.

    Product
    HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1261-2016·2016-07-20

    Pharmakon Recalls Ceftriaxone Injections Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 1,575 units of compounded Ceftriaxone 1GM injections due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0106-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1215-2016·2016-07-20

    Medaus Recalls Methyl B12 and Pyridoxine Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific lots of Methyl B12 and Pyridoxine vials because the company cannot guarantee the product is sterile.

    Product
    METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1ML Vials and b) 10ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1244-2016·2016-07-20

    Medaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns

    Medaus, Inc. is recalling specific vials of Testosterone Cypionate 25 mg/mL due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.

    Product
    TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1343-2016·2016-07-20

    Pharmakon Recalls Bupivacaine Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 70 units of Bupivacaine HCI 0.25% bags because the company cannot assure the products are sterile.

    Product
    Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0994-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1325-2016·2016-07-20

    Pharmakon Recalls Hydromorphone Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 90 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.

    Product
    HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1285-2016·2016-07-20

    Pharmakon Recalls Fentanyl Citrate Cadd Cassettes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 10mcg/mL cadd cassettes due to a lack of assurance of sterility. The affected products were distributed nationwide and to specific VA/DOD facilities.

    Product
    Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1265-2016·2016-07-20

    Pharmakon Recalls Epinephrine Injection Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 280 vials of compounded Epinephrine injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1338-2016·2016-07-20

    Pharmakon Recalls Midazolam HCI Syringes Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 2,000 units of compounded Midazolam HCI syringes due to a lack of assurance of sterility.

    Product
    Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0966-69
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1331-2016·2016-07-20

    Pharmakon Recalls Ropivacaine HCI Bags Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 129 bags of Ropivacaine HCI 0.2% due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.

    Product
    Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1293-2016·2016-07-20

    Pharmakon Recalls Hydromorphone PCA Vials Due to Sterility Concerns

    Pharmakon Pharmaceuticals is recalling 100 vials of Hydromorphone HCI 0.2mg/ml PCA solution due to a lack of assurance of sterility.

    Product
    HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1166-2016·2016-07-13

    Vital Care Compounder Recalls Testosterone Cypionate Due to Sterility Concerns

    Vital Care Compounder is recalling 13 units of Testosterone Cypionate 200mg/ml because aluminum crimps may not fully seal the vials, compromising sterility.

    Product
    TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2003-2016·2016-06-22

    Zimmer Dome Centric Shoulder Implant Component Recalled for Assembly Issues

    Zimmer GmbH is recalling 177 Dome Centric components from the Anatomical Shoulder System 2.0 because they may be difficult to disassemble during surgery, potentially causing delays or incomplete procedures.

    Product
    Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2016·2016-06-22

    CarboFix Recalls Piccolo Composite Tibia and Femoral Nailing System Guide Wires

    CarboFix Orthopedics is recalling 638 Piccolo Composite Ball Tip Guide Wires because the internal package was compromised, potentially affecting sterility.

    Product
    Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1857-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a breach of the barrier.

    Product
    Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0949-2016·2016-06-08

    Akorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns

    Akorn, Inc. is recalling specific lots of Sulfacetamide Sodium Ophthalmic Solution because they failed antimicrobial effectiveness testing, raising concerns about sterility.

    Product
    Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1851-2016·2016-06-08

    Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.

    Product
    Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1847-2016·2016-06-08

    Curity Gauze Sponges Recalled for Compromised Sterility

    Covidien LLC is recalling Curity Gauze Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1852-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1849-2016·2016-06-08

    Curity All Purpose Sponges Recalled Due to Compromised Sterility

    FDA is recalling Curity All Purpose Sponges due to compromised sterility from a barrier breach. The recall affects units distributed in the US and 20 other countries.

    Product
    Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2016·2016-06-08

    Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach

    The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a barrier breach.

    Product
    Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
    Category
    Medical Device
    Distribution
    Distributed nationwide