Agency classClass IIOur severity:High FDA (Devices)·Z-1695-2022·Announced 2022-09-14

Cysto Packs Recalled Due to Inadequate Sterilization Validation

American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving sterilization validation failure, which poses direct infection risk to patients. While no illnesses have been reported, sterilization failure on surgical devices is a significant risk-of-harm situation meeting the High severity threshold.

Plain-English summary

American Contract Systems, Inc. is recalling various Cysto Packs due to exposure to multiple sterilization cycles without proper validation for multiple exposures. The recalled devices include 21 units identified by specific tray numbers, sterilization lot numbers, and serial numbers.

The affected packs were distributed within the United States to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.

Improper sterilization validation poses a potential infection risk to patients. Health systems and distributors that received these devices should locate and quarantine the affected units and notify patients who may have received cystoscopy procedures using these packs. Contact American Contract Systems, Inc. for instructions on device return or destruction.

The recalled product

Product: Various Cysto Packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device
Hazard: sterilization-failure
infection-risk
Affected units: 21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Tray Number
Sterilization Lot
Lot Number
Bag Serial Number 1) LSRCFHCYTURC
2105051
883211
15142078 2) LSRCFHCYTURC
2106092
853211
44251068 3) LSRCYSTOTURF
2106181
834211
44251068 4) LSRCYSTOTURF
2108251
775211
44376072 5) JECY99B
2105182
862211
44108484-005 6) BHCY71H
2107011

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 17 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Same manufacturer · American Contract Systems, Inc.

See all →

Severe
FDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
High
FDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
High
Recall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
Moderate
American Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
Moderate
American Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02

Same hazard · sterilization failure