ArjoHuntleigh Sara Combilizer — Class II medical device recall Z-2718-2016
Terminated recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., reported 2016-09-14, distributed in AL, CA, CO, CT, FL, IL, MA, MD…. ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mech
| Recall number | Z-2718-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o., KOMORNIKI, Poland |
| Recall initiated | 2016-06-29 |
| Classified | 2016-09-02 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2019-03-08 |
| Distributed | AL, CA, CO, CT, FL, IL, MA, MD, MI, NC, NY, TX, VA |
| Countries outside the US | AE, AT, AU, CH, DE, DK, GB, IL, JP, NO, SE |
| Quantity | 106 |
| Serial numbers | 1404000112, 1404000113, 1404000114, 1404000115, 1404000116, 1404000117, 1404000118, 1404000119, 1404000120, P0294981, P0294982, P0294983, P0294984, P0294985, P0294986, P0295762, P0295846, P0295847, P0296130, P0296131, P0296315, P0296318, P0298158, P0298175, P0298176 and 81 more |
| Model numbers | APA1000-XX |
Product
ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
Reason for recall
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 during internal device testing. To date, there have been no adverse events or customer complaints related to the tipping phenomenon. The tipping hazard may occur when fully loaded Sara Combilizer in "stretcher mode" is lifted to the highest position (approximately 984 mm = 38 3/4") and tilted backwards to the angle of 25 degrees¿-28 degrees¿. Although such scenario has been defined as highly unlikely to occur during use with patients, as a commitment to quality, ArjoHuntleigh is providing customers with information on action needed. The Sara Combilizer may stay in use until the upgrade will be performed, on the condition that the tilt angle in the device ''stretcher mode" will be no greater than minus 15 degrees¿ and the device is not loaded over 330 lbs (150 kg).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2718-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.