CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report

ArjoHuntleigh Sara Combilizer recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o

ARJOHUNTLEIGH POLSKA Sp. z.o.o is recalling ArjoHuntleigh Sara Combilizer, distributed in 13 states. The recall was initiated on 29 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDevice Listing Number E101987, Model Number APA1000-XX; Serial numbers P0359671 , P0360103 , P0338345 , P0354548 , P0357690 , P0359672 , P0359673 , P0348548 , P0349629 , P0361336 , P0361337 , P0361875 , P0361876 , P0361877 , P0360104 , P0360105 , P0346000 , P0373592 , P0357691 , P0349634 , P0354549 , P0349627 , P0339257 , P0321458 , P0299662 , P0325930 , P0325931 , P0325933 , P0310854 , P0344175 , P0356357 , P0356362 , P0356363 , P0360990 , P0375493 , P0298175 , P0309635 , P0310848 , P0323622 , P0323624 , P0325167 , 1404000118 , P0296131 , P0296315 , P0298465 , P0319583 , P0333285 , P0333288 , P0339264 , P0343583 , P0343584 , P0343585 , P0343684 , P0344174 , P0353246 , P0364628 , 1404000112 , P0333284 , P0333290 , P0294982 , P0294983 , P0295762 , P0298158 , P0309472 , P0317162 , P0325970 , P0331310 , 1404000113 , 1404000119 , 1404000120 , P0325967 , P0332385 , P0333283 , P0339574 , P0296130 , P0296318 , P0321460 , P0332383 , 1404000115 , P0331312 , P0331311 , P0331318 , P0331319 , P0325968 , P0295846 , P0294981 , P0294985 , P0295847 , P0332386 , P0294984 , P0332384 , 1404000116 , 1404000117 , P0321461 , 1404000114 , P0294986 , P0298176 , P0323011 , P0361422 , P0361423 , P0363456 , P0357692 , P0360102 , P0328718 , P0328720 , P0328724 .

Quantity recalled106

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2718-2016
FDA event ID: 74506
Recalling firm: ARJOHUNTLEIGH POLSKA Sp. z.o.o, KOMORNIKI
Classification: Class II
Status: Terminated
Recall initiated: 29 Jun 2016
FDA classified: 2 Sep 2016
Reported: 14 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Jun 2016	Recall initiated by company
2 Sep 2016	Classified by FDA	+65 days
14 Sep 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

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

Where it was distributed

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.

Alabama California Colorado Connecticut Florida Illinois Massachusetts Maryland Michigan North Carolina New York Texas Virginia

Questions about this recall

Is ArjoHuntleigh Sara Combilizer recalled?

Yes. ARJOHUNTLEIGH POLSKA Sp. z.o.o recalled ArjoHuntleigh Sara Combilizer on 29 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2718-2016.

Why was it recalled?

Which lots are affected?

Device Listing Number E101987, Model Number APA1000-XX; Serial numbers P0359671 , P0360103 , P0338345 , P0354548 , P0357690 , P0359672 , P0359673 , P0348548 , P0349629 , P0361336 , P0361337 , P0361875 , P0361876 , P0361877 , P0360104 , P0360105 , P0346000 , P0373592 , P0357691 , P0349634 , P0354549 , P0349627 , P0339257 , P0321458 , P0299662 , P0325930 , P0325931 , P0325933 , P0310854 , P0344175 , P0356357 , P0356362 , P0356363 , P0360990 , P0375493 , P0298175 , P0309635 , P0310848 , P0323622 , P0323624 , P0325167 , 1404000118 , P0296131 , P0296315 , P0298465 , P0319583 , P0333285 , P0333288 , P0339264 , P0343583 , P0343584 , P0343585 , P0343684 , P0344174 , P0353246 , P0364628 , 1404000112 , P0333284 , P0333290 , P0294982 , P0294983 , P0295762 , P0298158 , P0309472 , P0317162 , P0325970 , P0331310 , 1404000113 , 1404000119 , 1404000120 , P0325967 , P0332385 , P0333283 , P0339574 , P0296130 , P0296318 , P0321460 , P0332383 , 1404000115 , P0331312 , P0331311 , P0331318 , P0331319 , P0325968 , P0295846 , P0294981 , P0294985 , P0295847 , P0332386 , P0294984 , P0332384 , 1404000116 , 1404000117 , P0321461 , 1404000114 , P0294986 , P0298176 , P0323011 , P0361422 , P0361423 , P0363456 , P0357692 , P0360102 , P0328718 , P0328720 , P0328724 .

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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