PlainRecalls

Custom Healthcare Systems, Inc.

Compiled from official public sources by the editorial team.

33 recalls on record · Latest: Feb 5, 2020

Custom Healthcare Systems, Inc. Recall Insight

Custom Healthcare Systems, Inc. appears on 33 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.032% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 5, 2020, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 33 entries, severity tagging shows 0 critical, 33 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 33 of 33 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (33). The date window on this page runs from Feb 13, 2013 to Feb 5, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 5, 2020

Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLO…

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000

FDA Devices Moderate Oct 31, 2018

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

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884

FDA Devices Moderate Oct 31, 2018

(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product…

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538

FDA Devices Moderate Jul 29, 2015

Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

FDA Devices Moderate Feb 13, 2013

Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical …

FDA Devices Moderate Feb 13, 2013

Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing mu…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.