The retailer urged anyone who owns the Twist & Turn Rattle to stop using it immediately and return it to any M&S store for a full refund.
No injuries have been reported, the firm said, but it warned the product could pose a hazard.
In a notice M&S said: “Whilst no injuries have been reported, due to the manufacturing fault there is a possibility that the balls contained inside could be released, presenting a potential hazard.
“As the safety of customers is the top priority, M&S is issuing a product recall notice for the small number (c.400) sold.”
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The £12 product, which was on sale between November last year and July and aimed at babies aged three months and above, cannot be returned to the firm’s Simply Food or Outlet stores.
M&S said none of its other products is affected.