The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1520-2015·Announced 2015-05-06

AmTryke Model 1424 Hand Cycle Recalled for Cracked Frames

Amtryke LLC is recalling 53 Model 1424 Community Cruiser Hand Cycles due to complaints of cracked frames. The recall covers units distributed nationwide to 18 states.

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: The recall involves a structural defect (cracked frames) in a mobility device, which poses a risk of harm to users, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Amtryke LLC is recalling 53 units of the AmTryke Model 1424 Community Cruiser Hand Cycle. This product is a therapeutic tricycle. The recall is being conducted due to complaints of cracked frames.

The affected units were distributed nationwide to Alabama, California, Florida, Hawaii, Illinois, Kentucky, Kansas, Louisiana, Michigan, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, and West Virginia. The specific units are identified by Model 1424, System number 50-HC-1424, and Batch numbers 2-1301 and GM-0314.

Consumers with this product should stop using it immediately and contact Amtryke LLC for instructions on how to proceed with the recall.

The recalled product

Product
AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle.
Manufacturer
Amtryke LLC
Category
Medical Device — Mobility Aids
Hazard
Affected units
53

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 (3)

  • Model: 1424
  • System number 50-HC-1424
  • Batch number 2-1301 and GM-0314.

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

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