The Recall Desk

Hazard

Infection recalls

2,547 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,547
Critical
31
Severe
1,678
Most recent
2026-09-09

Of the 2,547 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 1,678 (66%) are Severe.

Which agencies issued them

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.

1351–1375 of 2547

  • HighFDA (Devices)·Z-1421-2016·2016-04-20

    Customed Neuro-Spine Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 81 Neuro-Spine Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1466-2016·2016-04-20

    Customed Basic Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 55 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1469-2016·2016-04-20

    Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues

    Customed, Inc. is recalling 44 Labor and Delivery Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1423-2016·2016-04-20

    Customed Recalls Umbilical Vessel Catheter Kits Due to Sterilization Concerns

    Customed, Inc. is recalling 40 umbilical vessel catheter kits distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1403-2016·2016-04-20

    Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 132 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1489-2016·2016-04-20

    Customed Femoral Angiography Surgical Pack Recalled for Sterilization Issues

    Customed, Inc. is recalling 16 units of Femoral Angiography Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1438-2016·2016-04-20

    Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 168 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1399-2016·2016-04-20

    Customed OB Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 32 OB Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1484-2016·2016-04-20

    Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 108 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1402-2016·2016-04-20

    Customed Universal Drainage Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 900 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1416-2016·2016-04-20

    Customed Laminectomy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 42 Laminectomy Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.

    Product
    Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1473-2016·2016-04-20

    Customed Laparoscopy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 60 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1445-2016·2016-04-20

    Customed Surgical Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 280 surgical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1420-2016·2016-04-20

    Customed Premium Arthroscopy Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 85 Premium Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1251-2016·2016-04-06

    IMCO Conforming Stretch Gauze Bandages Recalled for Sterility Failure

    Amd Ritmed is recalling IMCO Conforming Stretch Gauze Bandages because FDA testing found the product was not sterile and tested positive for Bacillus bacteria.

    Product
    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, con
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1148-2016·2016-03-23

    Zimmer NexGen MIS Tibia Plate Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling NexGen MIS Tibia Plates due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR 5950047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2016·2016-03-23

    Zimmer Free-Lock Tube and SCP Plate Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 285 units of Free-Lock Tube & SCP Plate devices due to insufficient sealer calibration data affecting sterility.

    Product
    Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT 1181145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0757-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Bupivacaine Syringes

    Hartley Medical Center Pharmacy is recalling specific syringes of Hydromorphone and Bupivacaine due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0755-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/Clonidine HCL 450 mcg/ml syringes due to a lack of assurance of sterility.

    Product
    Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0739-2016·2016-03-16

    Hartley Medical Center Recalls Morphine and Baclofen Syringes for Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Morphine Sulfate and Baclofen syringes due to a lack of assurance of sterility. The affected products were distributed nationwide.

    Product
    Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0751-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone and Fentanyl Syringes

    Hartley Medical Center Pharmacy is recalling specific hydromorphone and fentanyl syringes due to a lack of assurance of sterility.

    Product
    Hydromorphone HCL 10 mg/ml/Fentanyl Citrate 0.15 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Sufentanil Citrate Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Sufentanil Citrate/Clonidine/Bupivacaine syringes because the agency could not ensure the product was sterile.

    Product
    Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide