American Contract Systems recalls
22 official recalls and safety alerts involving American Contract Systems since 2022-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with American Contract Systems or the relevant agency.
- 2026-10-07
USAmerican Contract Systems Inc recalls Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989…
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to…
FDA · DeviceAmerican Contract Systems IncUS Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and…Official notice →- 2026-09-02
- US
American Contract Systems Inc recalls American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable…
FDA · DeviceAmerican Contract Systems IncUS Nationwide distribution in the states of IA, OH.Official notice → - US
American Contract Systems Inc recalls American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable…
FDA · DeviceAmerican Contract Systems IncUS Nationwide distribution in the states of IA, OH.Official notice → - 2026-08-26
- US
American Contract Systems Inc recalls American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number…
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected…
- 2026-05-13
- US
American Contract Systems Inc recalls Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers…
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential…
FDA · DeviceAmerican Contract Systems IncUS distribution to MN. No OUS distribution.Official notice → - 2025-10-22
- US
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to…
FDA · DeviceAmerican Contract Systems Inc.US Nationwide distribution in the states of SD, IA, MN, WA, IL.Official notice → - 2025-09-03
- US
American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL…
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS…
- 2025-06-18
- US
American Contract Systems, Inc. recalls LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model:…
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality…
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the state of CO.Official notice → - 2025-04-02
- US
- 2025-03-26
- US
American Contract Systems Inc recalls CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
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.
- US
American Contract Systems Inc recalls MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
FDA · DeviceAmerican Contract Systems IncUS Nationwide distribution in the state of OH.Official notice → - 2024-10-02
- US
American Contract Systems, Inc. recalls Pacemaker, COPM11B; 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…
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of MO, MN, MA, OH, NE.Official notice → - 2024-08-14
- US
American Contract Systems, Inc. recalls American Contract Systems Spine Pack convenience kit
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.Official notice → - 2024-07-17
- US
American Contract Systems Inc recalls TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- 2024-02-07
- US
American Contract Systems, Inc. recalls Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE…
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked"…
- 2023-11-01
- US
American Contract Systems, Inc. recalls LAVH, REF BBLV21C
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…
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of FL, IA.Official notice → - 2023-06-21
- US
American Contract Systems, Inc. recalls Total Knee Pack, REF CETJ130, medical convenience kits
Incorrect expiration date on product.
- 2022-11-30
- US
American Contract Systems, Inc. recalls BASIN SET, MEBS42K, general surgical kit
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.
- 2022-10-19
- US
American Contract Systems, Inc. recalls COVID Test Kit Nonsterile
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
- 2022-09-14
- US
American Contract Systems, Inc. recalls Various Angiography packs/trays
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
FDA · DeviceAmerican Contract Systems, Inc.Distribution within the United States to health systems and distributors in…Official notice → - 2022-07-13
- US
American Contract Systems, Inc. recalls Clean Catch Urine Kit NS 178489, AHMU58A
Affected products were assembled off-site by individuals who may not have been properly trained.
FDA · DeviceAmerican Contract Systems, Inc.US distribution in the state of Minnesota.Official notice → - 2022-05-18
- US
American Contract Systems, Inc. recalls ACS Cath Lab Pack
Product was sterilized with a higher than specification EO concentration.
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of IL, MO, NE, and TX.Official notice →