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

Endovascular AAA Pack, ESED52B; Medical convenience kit

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Official source for Endovascular AAA Pack, ESED52B; Medical convenience kit
FDA device enforcement

Endovascular AAA Pack, ESED52B; Medical convenience kit

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Official source for Endovascular AAA Pack, ESED52B; Medical convenience kit
FDA device enforcement

Day Surgery General Pack, FHGE18T; Medical convenience kit

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Official source for Day Surgery General Pack, FHGE18T; Medical convenience kit
FDA device enforcement

Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Official source for Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
FDA device enforcement

Paracentesis Thoracente, SLPT76H; Medical convenience kit

ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Official source for Paracentesis Thoracente, SLPT76H; Medical convenience kit

Reasons in these listed records

  • ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
  • During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
  • Sterility assurance with procedure trays
  • ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

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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