The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 2228

  • SevereFDA (Devices)·Z-0355-2015·2014-12-10

    Customed Shoulder Pack Recalled Due to Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 96 Shoulder Packs (catalog #900-2616) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Shoulder Pack, catalog #900-2616 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-0284-2015·2014-12-10

    Customed Premium Laparotomy Pack Recalled for Compromised Sterility

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

    Product
    Premium Laparotomy Pack, Catalog number 900-1296. 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-0407-2015·2014-12-10

    Customed Medical Kits Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 100 units of medical kits (Catalog # 900-913) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    , Catalog # 900-913 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-0373-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 96 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-3178. 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-0389-2015·2014-12-10

    Customed Laparoscopy Cholecystectomy Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 192 units of Laparoscopy Cholecystectomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. 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-0412-2015·2014-12-10

    Customed Arthoscopy Packs Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 120 Arthoscopy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Arthoscopy Pack, Catalog # 900-982 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-0265-2015·2014-12-10

    Customed Angiodrape Packs Recalled for Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 1,152 Angiodrape Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiodrape Pack, Catalog number 900-002. 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-0352-2015·2014-12-10

    Customed Arthroscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 75 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Arthroscopy Pack, catalog #900-2609 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-0288-2015·2014-12-10

    Customed Open Heart Tray Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 108 Open Heart Trays because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Open Heart Tray, Catalog number 900-1393. 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-0295-2015·2014-12-10

    Customed Angiography Pack Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 70 Angiography Packs (Catalog 900-1488) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Angiography Pack, Catalog number 900-1488. 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-0335-2015·2014-12-10

    Customed Laparoscopy Colorectal Surgical Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Colorectal Surgical Pack, catalog #900-2259A 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-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-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
  • SevereFDA (Devices)·Z-0405-2015·2014-12-10

    Customed Urology Pack Recalled for Sterility and Contamination Risks

    Customed, Inc. is recalling 195 Urology Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.

    Product
    Urology Pack, Catalog # 900-868 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-0411-2015·2014-12-10

    Customed Strabismus And Plastic Pack Recalled for Sterility Compromise

    Customed, Inc. is recalling 120 Strabismus And Plastic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.

    Product
    Strabismus And Plastic Pack, Catalog # 900-946 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-0384-2015·2014-12-10

    Customed Laparoscopy Packs Recalled for Sterility Compromise and Contamination Risk

    Customed, Inc. is recalling 240 Laparoscopy Packs (Catalog 900-474) due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-474. 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-0344-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 400 units of Laparotomy Pack 1 (2 & 3) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparotomy Pack 1 (2 & 3), catalog #900-2490 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-0400-2015·2014-12-10

    Customed Neuro Pack Recalled Due to Sterility and Contamination Risks

    Customed, Inc. is recalling 36 Neuro Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Neuro Pack, Catalog # 900-752 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-0337-2015·2014-12-10

    Customed Vaginal Procedure Packs Recalled for Sterility Compromise

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

    Product
    Vaginal Procedure Pack, catalog #900-2385 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-0386-2015·2014-12-10

    Customed Laparoscopy Packs Recalled Due to Sterility Compromise

    Customed, Inc. is recalling 126 Laparoscopy Packs (Catalog 900-486) due to compromised sterility and manufacturing deficiencies that may result in patient infection.

    Product
    Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states