The Recall Desk

Manufacturer

Custom Healthcare Systems, Inc.

33 recalls in our database name Custom Healthcare Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
33
Critical
0
Severe
1
Most recent
2020-02-05

Of the 33 recalls from Custom Healthcare Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–33 of 33

  • HighFDA (Devices)·Z-0249-2019·2018-10-31

    Custom Healthcare Systems Recalls Vaginal Speculums Due to Sterility Compromise

    Custom Healthcare Systems is recalling vaginal speculums because incorrect sealing specifications compromised product sterility.

    Product
    (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0256-2019·2018-10-31

    Custom Healthcare Systems Recalls 50 Curved Pean Forceps Kits

    Custom Healthcare Systems is recalling 50 units of curved pean forceps kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2096-2015·2015-07-29

    Safety PICC Insertion Tray Recalled for Incorrect Non-Sterile Packaging Item

    Custom Healthcare Systems is recalling Safety PICC Insertion Trays because the outer packaging contains an incorrect non-sterile saline flush syringe.

    Product
    Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0797-2013·2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling breast biopsy trays because they may contain particulate matter in the included sodium chloride.

    Product
    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2013·2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling 80 breast biopsy trays because they may contain particulate matter in the pharmaceuticals used for injection.

    Product
    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide