FDA Medical Device Recalls (openFDA)
Tollos: Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
- Recall number
- Z-0245-2023
- Recalling firm
- Tollos
- Product
- Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
- Status
- Open, Classified
- Initiated
- 2022-10-24
- Posted
- 2022-11-17
- Terminated
- not on file
- Reason
- Two customers reported four incidents in which the lifting strap broke while lifting a patient. If the IC strap fails during use, the patient may fall causing injury to them or the caregiver(s).
- Root cause
- Equipment maintenance
- Action
- On October 24, 2022, the firm notified affected customers via Urgent Medical Device Correction letters. The firm is updating their operator's manual and service manual with instructions to inspect the IC straps prior to use, along with photo illustrations of lifting straps demonstrating wear/damage conditions that indicate replacement must be performed. Access complete Operator s & Service Manuals on the web at www.tollos.com/service-bulletins. Tollos can be contacted by e-mail at service@tollos.com.
- Quantity
- 1273 US; 70 OUS
- Distribution
- Worldwide - US Nationwide distribution and the countries of Canada and United Arab Emirates.
- Lot, serial or model codes
- UDI-DI 00817956021 (not yet uploaded to GUDID)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNG
- Firm FEI
- 3008406502
- Firm city
- Owings Mills
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28