American Contract Systems Recalls

14 recalls found for American Contract Systems. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Basic Biopsy Trays Re-Gassed After EO Sterilization (2025)

American Contract Systems recalled 32,433 basic biopsy trays distributed nationwide in the United States. These trays were re-gassed after a nonconformance occurred during the initial Ethylene Oxide gas injection. The trays have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using affected trays and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Cardiac Cath Lab Kits Due to Re-Gassed Sterilization Risk (

American Contract Systems recalled 32,433 cardiac cath lab kits distributed nationwide to healthcare providers. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. The kits have not been validated for exposure to multiple sterilization cycles and cannot be guaranteed safe.

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Basic Biopsy Tray Recalled for Re-Gassing Hazard (32,433 Units) 2025Recall

American Contract Systems recalled 32,433 Basic Biopsy Trays nationwide after discovering re-gassing occurred following a nonconformance during Ethylene Oxide sterilization. The trays have not been validated for exposure to multiple sterilization cycles, so product quality and safety cannot be confirmed. Healthcare providers and patients should stop using the device immediately and follow theメーカー?

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems LKRA40G Radiology Pack Recalled Over Unvalidated Re-sterilization (HIGH)

American Contract Systems recalled 32,433 radiology packs after a nonconformance during EO gas injection. The items were re-gassed and not validated for multiple sterilization cycles. The recall is active as of 2025-10-22. US distribution included SD, IA, MN, WA, IL. Health risks prompt immediate removal from use.

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalled 32,433 Orthopedic Surgical Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide in SD, IA, MN, WA and IL. The devices were re-gassed after a nonconformance in the Ethylene Oxide sterilization process. The sterilization cycles have not been validated, so quality, safety and effectiveness cannot be confirmed. Consumers and healthcare providers should stop using the kits

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems IHDC30R D AND C PACK Medical Kits Recalled Over Re-Gassing (32,433 Units,

American Contract Systems recalled the IHDC30R D AND C PACK medical convenience kits distributed nationwide in the United States. The recall stems from a nonconformance during Ethylene Oxide gas injection that led to re-gassing. The products have not been validated for exposure to multiple sterilization cycles. Health safety cannot be confirmed for re-gassed units. Stop using them and await recall

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Labor Delivery Packs Recalled for Re-Gassed Sterilization Flaw (2025)

American Contract Systems recalled 32,433 labor and delivery packs nationwide in the United States, including the states of South Dakota, Iowa, Minnesota, Washington and Illinois. Re-gassing occurred after a nonconformance in the Ethylene Oxide gas injection process. The affected packs have not been validated for exposure to multiple sterilization cycles. Hospitals and health systems should stop使用

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Medical Convenience Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process and have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using these products immediately and follow the manufacturer's recall.

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems High-Index Medical Kits Recalled for Re-Gassing After EO Sterilization Non

American Contract Systems recalled 32,433 medical convenience kits nationwide in the United States after re-gassing sterilization cycles. The recall covers multiple packs including HEART PACK and PACEMAKER PACK with 2025 recall date. The safety issue centers on EO gasset validation failures after a nonconformance during initial gas injection. Stop using immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems High-Rire Recall: 32,433 Medical Convenience Kits Recalled for Re-GassedEO

American Contract Systems recalled 32,433 medical convenience kits nationwide after finding re-gassed devices from EO sterilization. The recall affects five product lines with UDI-DI codes and Lot numbers. The re-gassing process has not been validated for multiple sterilization cycles, calling into question product safety and effectiveness. Health providers and patients should stop using these kit

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Medical Convenience Kits Recalled for Re-Gassing Risk

American Contract Systems recalled 32,433 medical convenience kits after it was discovered they were re-gassed after sterilization failure. The sterilization process may compromise the product's quality, safety, and effectiveness. Healthcare providers must stop using these kits immediately and follow up with the manufacturer for instructions.

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalling 32,433 UDPG88W PICC G-TUBE Pack in 2025 Recall

American Contract Systems recalled 32,433 UDPG88W PICC G-TUBE PACK medical kits nationwide after a nonconformance in Ethylene Oxide sterilization led to re-gassing. The devices have not been validated for multiple sterilization cycles. Healthcare providers and patients should stop using the kit immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Medical Convenience Kits Over EO Re-Gassing Risk (2025)

American Contract Systems Inc. recalls 32,433 medical convenience kits distributed nationwide to healthcare facilities in SD, IA, MN, WA, and IL. Re-gassed after a nonconformance occurred during Ethylene Oxide gas injection. The kits have not been validated for multiple sterilization cycles. Healthcare providers should stop using the devices immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Angio Packs Over Re-Gassed EO Sterilization (2025)

American Contract Systems is recalling 32,433 medical Angio Packs distributed nationwide in the United States. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. Healthcare facilities and patients should stop using the devices and follow the manufacturer’s recall instructions.

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Brand Statistics

Total Recalls
14
Pages
1

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