ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.

Recall Insight

This FDA Devices action (record #Z-2718-2016) was formally reported on September 14, 2016, with the manufacturer initiating the action on June 29, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. ARJOHUNTLEIGH POLSKA Sp. z.o.o. is listed as the recalling firm, operating out of KOMORNIKI. Federal records indicate 106 units are affected.

The documented reason for this recall is: ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the patient or the caregiver. The tipping phenomenon has been found … Distribution data in the federal record shows the product reached: CO, AL, MA, NC, MI, NY, FL, MD, CA, VA, CT, TX, and IL; Australia, Austria, Denmark, Germany, Israel, Japan, Norway, Sweden, Switzerland, UAE, and UK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.