Recall archive
14 recalls · page 1 of 1
Reported Jun 18, 2025
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual…
FDA (openFDA device enforcement)
Reported Apr 2, 2025
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand · Product · Product details — Sterility assurance with procedure trays
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
PACEMAKER PACK, SLCV01J; Medical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
American Contract Systems Hand Pack convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand · Product · Product details — Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization…
17 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
General Pack, REF BBGP31C
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12)…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2023
Total Knee Pack, REF CETJ130, medical convenience kits
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.American Contract Systems, Inc.
Matched: Brand — Incorrect expiration date on product.
FDA (openFDA device enforcement)
Reported Nov 30, 2022
BASIN SET, MEBS42K, general surgical kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Oct 19, 2022
COVID Test Kit Nonsterile
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
FDA (openFDA device enforcement)
Reported Sep 14, 2022
Various Angiography packs/trays
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — Product was exposed to multiple sterilization cycles without validation for multiple exposures.
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2022
Clean Catch Urine Kit NS 178489, AHMU58A
High riskUsing this product could cause serious injury, illness or death — stop using it now.American Contract Systems, Inc.
Matched: Brand — Affected products were assembled off-site by individuals who may not have been properly trained.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 18, 2022
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — Product was sterilized with a higher than specification EO concentration.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2019
Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — Potential that product has not reached complete sterilization,
FDA (openFDA device enforcement)
Reported Nov 21, 2018
Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Contract Systems, Inc.
Matched: Brand — Powdered Surgical Gloves are an FDA banned substance.
FDA (openFDA device enforcement)
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