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.

426–450 of 3438

  • HighFDA (Drugs)·D-0411-2024·2024-04-03

    Labetalol HCl Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.

    Product
    labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0409-2024·2024-04-03

    FDA recalls HYDROmorphone injection for lack of sterility assurance

    SCA Pharmaceuticals is recalling HYDROmorphone HCl injectable syringes nationwide due to lack of sterility assurance. The FDA issued this Class II recall affecting multiple lot numbers.

    Product
    HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0403-2024·2024-04-03

    Fentanyl Injection Recalled for Lack of Sterility Assurance

    SCA Pharmaceuticals recalls fentanyl injection syringes due to concerns about sterility. No illnesses have been reported, but patients and healthcare providers should check if they have products from the affected lot numbers, which expired in December 2023.

    Product
    fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2024·2024-04-03

    Alcon bulb irrigation syringes recalled due to sterile barrier compromise

    Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.

    Product
    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0399-2024·2024-04-03

    FDA Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 324 syringes of fentanyl/bupivacaine epidural injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if affected.

    Product
    fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0407-2024·2024-04-03

    Hydromorphone Injection Recalled Due to Lack of Sterility Assurance

    SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.

    Product
    HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2024·2024-03-20

    CVS Health Wound Dressing Recalled for Failed Sterility Testing

    Medline Industries is recalling CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) due to sterility failure. The non-sterile dressings may introduce infection risk when applied to wounds.

    Product
    CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0384-2024·2024-03-20

    FDA Recalls HylaTears Lubricant Eye Drops for Sterility Assurance Issue

    Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.

    Product
    hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2024·2024-03-13

    Titanium Hindfoot Arthrodesis Cannulated Nails Recalled Due to Sterilization Failure

    Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.

    Product
    13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2024·2024-03-13

    TFNA Femoral Nail Recalled Due to Sterility Confirmation Issue

    Synthes is recalling 11 TFNA Femoral Nails due to sterility failures. The affected units worldwide cannot be confirmed as sterilized and pose infection risks to patients.

    Product
    TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2024·2024-03-13

    Paragon 28 Phantom TTC Nail distributed prior to sterilization

    Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.

    Product
    Phantom TTC Nail, 10.0 X 200mm, Right
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1241-2024·2024-03-13

    Synthes Clavicle Plate Implants Recalled Due to Sterility Failure

    Synthes is recalling 47 VA-LCP Clavicle Plate 2.7 bone fixation implants (Lot 1201P12) distributed worldwide because sterility cannot be confirmed. Non-sterile surgical implants pose risk of infection.

    Product
    VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2024·2024-03-13

    Synthes 1.5MM Surgical Drill Bit Recalled Due to Sterilization Concerns

    Synthes has recalled 17 units of 1.5MM surgical drill bits worldwide because the products could not be confirmed as sterilized, posing an infection risk during orthopedic procedures.

    Product
    1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2024·2024-03-13

    Synthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility

    Synthes (USA) Products LLC is recalling 30 units of 2.5MM sterile surgical drill bits (Lot 77P6506) because sterility cannot be confirmed. Non-sterile surgical instruments pose a risk of surgical site infection if used in orthopedic procedures.

    Product
    2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2024·2024-03-13

    Synthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed

    Synthes is recalling 30 Opal intervertebral cage spinal implants (Lot 427P153) because sterility cannot be confirmed. Patients with these devices should contact their surgeon immediately.

    Product
    Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2024·2024-03-13

    Paragon 28 Phantom TTC Nail recalled for unsterilized distribution

    Paragon 28, Inc. is recalling the Phantom TTC Nail (10.0 X 150mm, RIGHT) distributed in California, as these devices were shipped prior to sterilization. Unsterilized surgical implants pose a serious risk of infection and complications.

    Product
    Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1256-2024·2024-03-13

    Paragon 28 Phantom TTC Nail Recalled Due to Improper Sterilization

    Paragon 28 has recalled the Phantom TTC Nail (11.5 X 250mm, RIGHT, REF: P31-615-250R) distributed in California prior to sterilization. Non-sterilized surgical implants pose a risk of infection.

    Product
    Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1246-2024·2024-03-13

    Aesculap Disposable Trocars with Dilating Pins Recalled for Packaging Damage

    Aesculap Inc is recalling disposable trocars with dilating pins due to potential sterile blister packaging damage that may compromise sterility. The affected product (code EK236SU) was distributed in the US and Canada.

    Product
    DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2024·2024-03-13

    RAPIDSORB IPS Battery Pack recalled due to unconfirmed sterility

    Synthes is recalling 10 units of RAPIDSORB IPS Battery Pack Sterile because the products cannot be confirmed as sterile. The affected lot was distributed worldwide to medical facilities. Patients should consult their healthcare provider about replacement options.

    Product
    RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2024·2024-03-13

    Synthes RIA Tube Assembly Recalled for Unconfirmed Sterility

    Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.

    Product
    RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2024·2024-03-13

    TFNA Femoral Nail surgical implant recalled for sterility failure

    Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.

    Product
    TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1102-2024·2024-03-06

    Surgical kits and trays recalled due to lack of sterility

    Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1136-2024·2024-03-06

    Centurion LVAD Maintenance Kits Recalled for Potential Sterility Failure

    Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.

    Product
    Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1123-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Failure

    Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF CDS983913S; c) GYN LAPAROSCOPY CDS, REF CDS983913T; d) GYN LAPAROSCOPY CDS, REF CDS983913U; e) GYN LAPAROSCOPY CDS, REF CDS983913V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1113-2024·2024-03-06

    Medline Medical Kits Recalled Due to Potential Lack of Sterility

    Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.

    Product
    Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445…
    Category
    Medical Device
    Distribution
    Distributed nationwide