FDA Medical Device Recalls (openFDA)
Bock,Otto,Orthopedic Ind,Inc: Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X
- Recall number
- Z-0181-04
- Recalling firm
- Bock,Otto,Orthopedic Ind,Inc
- Product
- Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X
- Status
- Terminated
- Initiated
- 2003-10-29
- Posted
- 2004-07-20
- Terminated
- 2005-11-07
- Reason
- Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.
- Root cause
- Other
- Action
- Recall letters dated October 23, 2003 were sent to the consignees on 10/29/03 and 10/30/03. The letters requested that the consignees contact the firm''s Customer Service Department to report the affected units they have. The letter states that the Customer Service Department will send the consignees the necessary field modification kits and instructions to correct the problem in the units they have and have located at their customers.
- Quantity
- not on file
- Distribution
- The product was distributed nationwide in the United States and to Canada and Mexico.
- Lot, serial or model codes
- The affected strollers were sold between August 1, 2002 and September 23, 2003. The affected strollers are those strollers equipped with the trigger-activated tilting mechanism. (The firm''s notification letter has photographs of the trigger-activated tilting mechanism which can be used to identify the devices needing correction.)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IOR
- Firm FEI
- 2182293
- Firm city
- Minneapolis
- Firm state
- MN
- 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