American Contract Systems, Inc. recall records

193 reported ongoing

194 records in this archive. Latest source date Jun 29, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Pediatric Heart SJH, REF SJPH34K

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IA.

Official source for Pediatric Heart SJH, REF SJPH34K
FDA device enforcement

Vasc. Open CVOR SJH, REF SJVO56B

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IA.

Official source for Vasc. Open CVOR SJH, REF SJVO56B
FDA device enforcement

Robotics Pack, REF SJVO56B

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IA.

Official source for Robotics Pack, REF SJVO56B
FDA device enforcement

Robotics Pack, REF SSRO22D

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IA.

Official source for Robotics Pack, REF SSRO22D
FDA device enforcement

Sub Q Recorder Pack, REF BPRC87A

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IA.

Official source for Sub Q Recorder Pack, REF BPRC87A
FDA device enforcement

Cath Cardiac Pack, REF IHCC03V

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of FL, IA.

Official source for Cath Cardiac Pack, REF IHCC03V
FDA device enforcement

Various ENT Packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Class IIReported ongoing

Distribution: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Official source for Various ENT Packs
FDA device enforcement

Various Laparoscopy Packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Class IIReported ongoing

Distribution: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Official source for Various Laparoscopy Packs
FDA device enforcement

Various Cysto Packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Class IIReported ongoing

Distribution: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Official source for Various Cysto Packs
FDA device enforcement

Breast Abdominoplasty Pack

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Class IIReported ongoing

Distribution: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Official source for Breast Abdominoplasty Pack
FDA device enforcement

Various convenience packs

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Class IIReported ongoing

Distribution: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Official source for Various convenience packs

Reasons in these listed records

  • During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the com...
  • Incorrect expiration date on product.
  • Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
  • Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.

These examples come from this result page and are not a ranking of every recall reason.

Checking American Contract Systems, Inc.

Is there a recall on american contract systems, inc. right now?

This archive contains 194 records, including 193 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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