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.

1–25 of 33

  • HighFDA (Devices)·Z-0863-2020·2020-02-05

    Custom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex

    Custom Healthcare Systems is recalling 240 inpatient dialysis kits because a component contains latex that was not listed on the product labels.

    Product
    Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0243-2019·2018-10-31

    CHS Cotton Tip Applicators Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 150 units of CHS Cotton Tip Applicators because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0260-2019·2018-10-31

    Custom Healthcare Systems Recalls Penrose Drain Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 24 units of Penrose Drain Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0242-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling specific lots of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0250-2019·2018-10-31

    CHS Custom Convenience Kits Recalled for Sterility Compromise

    Custom Healthcare Systems is recalling 630 CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0240-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 200 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0265-2019·2018-10-31

    Custom Healthcare Systems Recalls Surgical Gowns Due to Sterility Compromise

    Custom Healthcare Systems is recalling 89 units of surgical gowns and convenience kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0241-2019·2018-10-31

    Custom Healthcare Systems Recalls Injection Trays Due to Sterility Compromise

    Custom Healthcare Systems is recalling 40 units of CHS Custom Convenience Kit-INJECTION TRAY because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0246-2019·2018-10-31

    CHS Custom Convenience Kit-PAD recalled for compromised sterility

    Custom Healthcare Systems is recalling 160 units of CHS Custom Convenience Kit-PAD, COTTON SINGLE because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0263-2019·2018-10-31

    Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 60 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0267-2019·2018-10-31

    CHS Custom Convenience Kits Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 4,500 fenestrated drape kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0266-2019·2018-10-31

    Custom Healthcare Systems Recalls Non-Sterile Convenience Gowns

    Custom Healthcare Systems is recalling 72,832 units of convenience gowns because they were sealed with incorrect specifications, compromising sterility.

    Product
    CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0255-2019·2018-10-31

    Custom Healthcare Systems Recalls Sterility-Compromised Connector Packs

    Custom Healthcare Systems is recalling 150 units of CHS Custom Convenience Kit-CONNECTOR PACK due to incorrect sealing specifications that compromised product sterility.

    Product
    CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0245-2019·2018-10-31

    Custom Healthcare Systems Recalls Cast Padding Kits Due to Sterility Compromise

    Custom Healthcare Systems is recalling 30 units of cast padding kits because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
    Category
    Medical Device
    Distribution
    9 states