The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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 sterility compromise 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.

1876–1900 of 2235

  • SevereFDA (Devices)·Z-0368-2015·2014-12-10

    Customed Hair Restoration Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 60 Hair Restoration Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0256-2015·2014-12-10

    Customed Minor Laceration Trays Recalled Due to Compromised Sterility

    Customed, Inc. is recalling Minor Laceration Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0395-2015·2014-12-10

    Customed Recalls Pery Gyn Packs Due to Sterility Compromise

    Customed, Inc. is recalling 475 Pery Gyn Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0360-2015·2014-12-10

    Customed Knee and Hip Replacement Trays Recalled for Sterility Compromise

    Customed, Inc. is recalling 160 Knee and Hip Replacement trays due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray, Catalog #2726 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0334-2015·2014-12-10

    Customed Neuro Pack Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 114 Neuro Packs (catalog #900-2256) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Neuro Pack, catalog #900-2256 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0340-2015·2014-12-10

    Customed Basic Pack 1 (III) Recalled for Sterility Compromise

    Customed, Inc. is recalling 400 units of Basic Pack 1 (III) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Basic Pack 1 (III), catalog #900-2471 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0406-2015·2014-12-10

    Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 60 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Arthroscopy Pack, Catalog # 900-902 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0365-2015·2014-12-10

    Customed Cysto Tur Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 128 Cysto Tur Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0314-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 2,520 Laparotomy Packs (Catalog 900-176) because compromised sterility and inadequate storage increase the risk of patient infection.

    Product
    Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0328-2015·2014-12-10

    Customed Recalls Knee Arthroscopy Packs Due to Sterility Compromise

    Customed, Inc. is recalling 144 Knee Arthroscopy Packs because significant sterility compromises and manufacturing deficiencies may result in patient infection.

    Product
    Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0403-2015·2014-12-10

    Customed Laparotomy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0327-2015·2014-12-10

    Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 1,068 Angiography Packs due to significant compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, catalog #900-210 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0249-2015·2014-12-10

    Customed Incision and Drainage Trays Recalled for Compromised Sterility

    Customed, Inc. is recalling 9,200 Incision & Drainage Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0336-2015·2014-12-10

    Customed Full Body Drape Recalled for Sterility Compromise

    Customed, Inc. is recalling 308 units of General Line Full Body Drapes due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    General Line Full Body Drape, catalog #900-2262 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0376-2015·2014-12-10

    Customed Basic Pack W/Out Gown Recalled for Sterility Compromise

    Customed, Inc. is recalling 242 units of Basic Pack W/Out Gown due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Basic Pack W/Out Gown, Catalog number 900-345. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0398-2015·2014-12-10

    Customed Arthroscopy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 400 Arthroscopy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0339-2015·2014-12-10

    Customed Extremity Arm Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 92 Extremity Arm Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0387-2015·2014-12-10

    Customed Laparotomy Basic Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 70 Laparotomy Basic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0414-2015·2014-12-10

    Customed Peri Gyn Pack Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 230 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Peri Gyn Pack, Catalog # 900-997 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0391-2015·2014-12-10

    Customed Angiography Pack Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 210 Angiography Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Angiography Pack, Catalog number 900-610. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0329-2015·2014-12-10

    Customed Femoral Pack Recalled Due to Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 92 units of Femoral Packs (catalog #900-2164) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0396-2015·2014-12-10

    Customed O.B. Pack Recall Due to Sterility Compromise

    Customed, Inc. is recalling 420 O.B. Packs (Catalog 900-645) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0303-2015·2014-12-10

    Customed Femoral Pack Recall Due to Compromised Sterility

    Customed, Inc. is recalling 270 Femoral Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.

    Product
    Femoral Pack, Catalog number 900-164. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0316-2015·2014-12-10

    Customed Laparoscopy Premium Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 28 units of Laparoscopy Premium Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0380-2015·2014-12-10

    Customed Laparoscopy Chole Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 440 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states