B125P Patient Monitor (with E-module slot option), REF 6160000-002

Class I - Dangerous

🏥 Medical Devices Recalled: November 16, 2022 GE Medical Systems Diagnostic Equipment

What Should You Do?

Check if you have this product:
UDI/DI 00840682147224: Model Number 6160000-002-100174, Serial Numbers: SR522350004WA, SR522350001WA, SR522350002WA, SR522350003WA, SR522350005WA, SR522350006WA, SR522350007WA, SR522350008WA, SR522350009WA, SR522350010WA, SR522350011WA, SR522350012WA, SR522350013WA, SR522350014WA, SR522350015WA, SR522350016WA, SR522350017WA, SR522350018WA, SR522350019WA, SR522350020WA, SR522350021WA, SR522350047WA, SR522350048WA, SR522350049WA, SR522350050WA, SR522350088WA, SR522350051WA, SR522350053WA, SR522350054WA, SR522350055WA, SR522350087WA, SR522350089WA, SR522350090WA, SR522350091WA, SR522350092WA, SR522350093WA, SR522350094WA, SR522350095WA, SR522350096WA, SR522350097WA, SR522350098WA, SR522350168WA, SR522350165WA, SR522350166WA, SR522350167WA, SR522350169WA, SR522350170WA, SR522350171WA, SR522350172WA, SR522350173WA, SR522350174WA, SR522350175WA, SR522350176WA, SR522350177WA, SR522350178WA, SR522350179WA, SR522350183WA, SR522350180WA, SR522350181WA, SR522350182WA, SR522350160WA, SR522350161WA, SR522350162WA, SR522350163WA, SR522350164WA, SR522350135WA, SR522350136WA, SR522350137WA, SR522350138WA, SR522350139WA, SR522350140WA, SR522350141WA, SR522350142WA, SR522350143WA, SR522350144WA, SR522350145WA, SR522350146WA, SR522350147WA, SR522350148WA, SR522350149WA, SR522350150WA, SR522350151WA, SR522350152WA, SR522350153WA, SR522350155WA, SR522350156WA, SR522350157WA, SR522350158WA, SR522350159WA, SR522350111WA, SR522350112WA, SR522350116WA, SR522350113WA, SR522350114WA, SR522350115WA, SR522350117WA, SR522350118WA, SR522350119WA, SR522350120WA, SR522350121WA, SR522350122WA, SR522350123WA, SR522350124WA, SR522350125WA, SR522350126WA, SR522350127WA, SR522350128WA, SR522350129WA, SR522350130WA, SR522350131WA, SR522350132WA, SR522350133WA, SR522350134WA, SR522350099WA, SR522350100WA, SR522350101WA, SR522350102WA, SR522350103WA, SR522350104WA, SR522350105WA, SR522350106WA, SR522350107WA, SR522350108WA, SR522350109WA, SR522350110WA, SR522350022WA, SR522350023WA, SR522350024WA, SR522350034WA, SR522350031WA, SR522350032WA, SR522350033WA, SR522350035WA, SR522350036WA, SR522350037WA, SR522350038WA, SR522350039WA, SR522350040WA, SR522350041WA, SR522350042WA, SR522350043WA, SR522350044WA, SR522350045WA, SR522350046WA, SR522350027WA, SR522350028WA, SR522350029WA, SR522350030WA, SR522350026WA, SR522350025WA; Model Number 6160000-002-100767, Serial Numbers: SR522340004WA, SR522340001WA, SR522340002WA, SR522340003WA, SR522340005WA, SR522340006WA, SR522340007WA, SR522340008WA, SR522340009WA, SR522340010WA; Model Number 6160000-002-101962, Serial Numbers: SR522380044WA, SR522380041WA, SR522380042WA, SR522380043WA, SR522380058WA, SR522380055WA, SR522380056WA, SR522380057WA, SR522380059WA, SR522380061WA, SR522380060WA, SR522380062WA, SR522380063WA, SR522380064WA, SR522380065WA, SR522380066WA, SR522380067WA, SR522380068WA, SR522380045WA, SR522380046WA, SR522380047WA, SR522380048WA, SR522380049WA, SR522380050WA, SR522380051WA, SR522380052WA, SR522380053WA, SR522380054WA, SR522380069WA, SR522380070WA, SR522380071WA, SR522380072WA, SR522380073WA, SR522380074WA, SR522380075WA, SR522380076WA, SR522380077WA, SR522380078WA, SR522380079WA, SR522380080WA, SR522380081WA, SR522380082WA, SR522380083WA, SR522380084WA, SR522380085WA, SR522380086WA, SR522380087WA, SR522380088WA, SR522380089WA, SR522380090WA, SR522380092WA, SR522380091WA, SR522380001WA, SR522380027WA, SR522380028WA, SR522380029WA, SR522380030WA, SR522380031WA, SR522380032WA, SR522380034WA, SR522380035WA, SR522380036WA, SR522380037WA, SR522380038WA, SR522380039WA, SR522380040WA, SR522380093WA, SR522380094WA, SR522380095WA, SR522380096WA, SR522380097WA, SR522380098WA, SR522380099WA, SR522380100WA, SR522380101WA, SR522380102WA, SR522380103WA, SR522380104WA, SR522380105WA, SR522380106WA, SR522380107WA, SR522380111WA, SR522380108WA, SR522380109WA, SR522380110WA, SR522380115WA, SR522380112WA, SR522380113WA, SR522380114WA, SR522380116WA; Model Number 6160000-002-753161, Serial Numbers: SR521070001WA, SR521040006WA, SR521040007WA, SR521050002WA, SR521050025WA, SR521050026WA, SR521050027WA, SR521050029WA, SR521050032WA, SR521050033WA, SR521050035WA, SR521050036WA, SR521050038WA, SR521040003WA, SR521050003WA, SR521050004WA, SR521050005WA, SR521050008WA, SR521070006WA, SR521050001WA, SR521050037WA, SR521070003WA, SR521070007WA, SR521040017WA, SR521040022WA, SR521040002WA, SR521040010WA, SR521050034WA, SR521040020WA, SR521050030WA, SR521040009WA, SR521040001WA, SR521040004WA, SR521040008WA, SR521040011WA, SR521040012WA, SR521040014WA, SR521040018WA, SR521070005WA, SR521070004WA, SR521040013WA, SR521040016WA, SR521040019WA, SR521040021WA, SR521040023WA, SR521040015WA, SR521050006WA, SR521050028WA, SR521050031WA, SR521070002WA; Model Number 6160000-002-767129, Serial Numbers: SR521110001WA, SR521110002WA, SR521110003WA, SR521110004WA, SR521110005WA; Model Number 6160000-002-790743, Serial Numbers: SR521230001WA, SR521230002WA, SR521230003WA, SR521230004WA, SR521230005WA, SR521230006WA, SR521300002WA, SR521410008WA, SR521410009WA, SR521410010WA, SR521150001WA, SR521150002WA, SR521150003WA, SR521150004WA, SR522080001WA, SR521260010WA, SR521260011WA, SR521260012WA, SR521260013WA, SR521260014WA, SR521260015WA, SR521220031WA, SR521220028WA, SR521220029WA, SR521220030WA, SR521220032WA, SR521220033WA, SR521220034WA, SR521220035WA, SR521220036WA, SR521220037WA, SR521220038WA, SR521220039WA, SR521450004WA, SR521450003WA, SR521450005WA, SR521460017WA, SR521460014WA, SR521460015WA, SR521460016WA, SR521460018WA, SR521150005WA, SR521300001WA, SR521410004WA, SR521410001WA, SR521410002WA, SR521410003WA, SR521410005WA, SR521410006WA, SR521410007WA, SR521410011WA, SR521450001WA, SR521450002WA, SR521470031WA, SR521470030WA, SR522350066WA, SR522350064WA, SR522350065WA; Model Number 6160000-002-791942, Serial Numbers: SR521150009WA, SR521150006WA, SR521150007WA, SR521150008WA, SR521150010WA, SR521150011WA; Model Number 6160000-002-795077, Serial Numbers: SR521220026WA; Model Number 6160000-002-807391, Serial Numbers: SR521400015WA, SR521400016WA, SR521400017WA, SR521400018WA, SR521400019WA, SR521400020WA, SR521400021WA, SR521400022WA, SR521400007WA, SR521400009WA, SR521400008WA, SR521400010WA, SR521400011WA, SR521200012WA, SR521200009WA, SR521200015WA, SR521200016WA, SR521200017WA, SR521200018WA, SR521200014WA, SR521200019WA, SR521200011WA, SR521200028WA, SR521200020WA, SR521400013WA, SR521200013WA, SR521400014WA, SR521200010WA, SR521400012WA, SR521200021WA, SR521200022WA, SR521200023WA, SR521200027WA, SR521200024WA, SR521200025WA, SR521200026WA, SR521400004WA, SR521400005WA, SR521400006WA; Model Number 6160000-002-811089, Serial Numbers: SR521220005WA, SR521220006WA, SR521220007WA, SR521220008WA, SR521220009WA, SR521220010WA, SR521220011WA; Model Number 6160000-002-813390, Serial Numbers: SR521220012WA, SR521220013WA, SR521220014WA, SR521370012WA; Model Number 6160000-002-815200, Serial Numbers: SR521200040WA, SR521200046WA, SR521200048WA, SR521200049WA, SR521200045WA, SR521200050WA, SR521200051WA, SR521200053WA, SR521210001WA, SR521210003WA, SR521200041WA, SR521200042WA, SR521200043WA, SR521200047WA, SR521200044WA, SR521200039WA, SR521200055WA, SR521200057WA, SR521210002WA, SR521200052WA, SR521200054WA, SR521200056WA; Model Number 6160000-002-816411, Serial Numbers: SR521220015WA, SR521220016WA, SR521220017WA, SR521220018WA; Model Number 6160000-002-818359, Serial Numbers: SR521210011WA, SR521210012WA, SR521210013WA, SR521210014WA; Model Number 6160000-002-832284, Serial Numbers: SR521260001WA, SR521260002WA, SR521260003WA; Model Number 6160000-002-841595, Serial Numbers: SR521270053WA, SR521270051WA, SR521270052WA, SR521270054WA, SR521270055WA, SR521270056WA, SR521270057WA, SR521270058WA, SR521270059WA, SR521270060WA, SR521270038WA, SR521270035WA, SR521270036WA, SR521270037WA, SR521270039WA, SR521270040WA, SR521270041WA, SR521270042WA, SR521270043WA, SR521270044WA, SR521270045WA, SR521270046WA, SR521270047WA, SR521270048WA, SR521270049WA, SR521270019WA, SR521270016WA, SR521270017WA, SR521270018WA, SR521270020WA, SR521270021WA, SR521270022WA, SR521270023WA, SR521270027WA, SR521270029WA, SR521270030WA, SR521270031WA, SR521270032WA, SR521270033WA, SR521270034WA, SR521270050WA, SR521270026WA, SR521270028WA, SR521270024WA, SR521270025WA; Model Number 6160000-002-849738, Serial Numbers: SR521280006WA; Model Number 6160000-002-870236, Serial Numbers: SR521370042WA; Model Number 6160000-002-870818, Serial Numbers: SR521370043WA; Model Number 6160000-002-874089, Serial Numbers: SR521380015WA, SR521380013WA, SR521380014WA; Model Number 6160000-002-874722, Serial Numbers: SR521400003WA; Model Number 6160000-002-905758, Serial Numbers: SR521460049WA, SR521460050WA, SR521460051WA; Model Number 6160000-002-906055, Serial Numbers: SR521470022WA; Model Number 6160000-002-912058, Serial Numbers: SR521470072WA, SR521470073WA, SR521470074WA, SR521470075WA, SR521470076WA, SR521470077WA, SR521470078WA; Model Number 6160000-002-912766, Serial Numbers: SR521460035WA, SR521460036WA, SR521460037WA, SR521460038WA, SR521460039WA, SR521460040WA, SR521460041WA, SR521460042WA, SR521460043WA, SR521460020WA, SR521460026WA, SR521460033WA, SR521460030WA, SR521460021WA, SR521460022WA, SR521460028WA, SR521460032WA, SR521460034WA, SR521460003WA, SR521460004WA, SR521460005WA, SR521460006WA, SR521460007WA, SR521460008WA, SR521460009WA, SR521460010WA, SR521460011WA, SR521460012WA, SR521460024WA, SR521460025WA, SR521460031WA, SR521460027WA, SR521460029WA, SR521460013WA, SR521460023WA; Model Number 6160000-002-914630, Serial Numbers: SR522190006WA, SR522190007WA, SR522190008WA, SR522190009WA, SR522190010WA, SR521470042WA, SR521470043WA; Model Number 6160000-002-935475, Serial Numbers: SR521490001WA; Model Number 6160000-002-943015, Serial Numbers: SR521500004WA, SR521500001WA, SR521500002WA, SR521500003WA, SR521500005WA, SR521500006WA, SR521500007WA, SR521500008WA, SR521500009WA, SR521500010WA, SR521500011WA, SR521500012WA, SR521500013WA, SR521500014WA, SR521500015WA; Model Number 6160000-002-943237, Serial Numbers: SR522350057WA; Model Number 6160000-002-962992, Serial Numbers: SR522110003WA, SR522110002WA, SR522110001WA; Model Number 6160000-002-972536, Serial Numbers: SR522110022WA, SR522110019WA, SR522110020WA, SR522110021WA, SR522110023WA, SR522110024WA, SR522110025WA, SR522110026WA, SR522110027WA, SR522110028WA, SR522110029WA, SR522110030WA, SR522110031WA, SR522110032WA, SR522110033WA, SR522110034WA, SR522110035WA, SR522110036WA, SR522110037WA, SR522110038WA, SR522110039WA, SR522110040WA, SR522110041WA, SR522110042WA, SR522110043WA, SR522110044WA, SR522110045WA, SR522110046WA, SR522110047WA, SR522110048WA, SR522110052WA, SR522110049WA, SR522110050WA, SR522110051WA, SR522110053WA, SR522110091WA, SR522110088WA, SR522110089WA, SR522110090WA, SR522110092WA, SR522110093WA, SR522110094WA, SR522110095WA, SR522110096WA, SR522110097WA, SR522110098WA, SR522110099WA, SR522110100WA, SR522110101WA, SR522110102WA, SR522110103WA, SR522110104WA, SR522110105WA, SR522110106WA, SR522110107WA, SR522110108WA, SR522110109WA, SR522110110WA, SR522110111WA, SR522110112WA, SR522110113WA, SR522110007WA, SR522110004WA, SR522110005WA, SR522110006WA, SR522110008WA, SR522110009WA, SR522110010WA, SR522110011WA, SR522110012WA, SR522110016WA, SR522110013WA, SR522110014WA, SR522110015WA, SR522110017WA, SR522110018WA, SR522110057WA, SR522110054WA, SR522110055WA, SR522110056WA, SR522110058WA, SR522110059WA, SR522110060WA, SR522110061WA, SR522110062WA, SR522110063WA, SR522110064WA, SR522110065WA, SR522110066WA, SR522110067WA, SR522110068WA, SR522110069WA, SR522110070WA, SR522110071WA, SR522110072WA, SR522110073WA, SR522110074WA, SR522110075WA, SR522110076WA, SR522110077WA, SR522110078WA, SR522110079WA, SR522110080WA, SR522110081WA, SR522110082WA, SR522110083WA, SR522110087WA, SR522110084WA, SR522110085WA, SR522110086WA.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: GE Medical Systems, LLC
Reason for Recall:: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

B125P Patient Monitor (with E-module slot option), REF 6160000-002

Product Codes/Lot Numbers:

UDI/DI 00840682147224: Model Number 6160000-002-100174, Serial Numbers: SR522350004WA, SR522350001WA, SR522350002WA, SR522350003WA, SR522350005WA, SR522350006WA, SR522350007WA, SR522350008WA, SR522350009WA, SR522350010WA, SR522350011WA, SR522350012WA, SR522350013WA, SR522350014WA, SR522350015WA, SR522350016WA, SR522350017WA, SR522350018WA, SR522350019WA, SR522350020WA, SR522350021WA, SR522350047WA, SR522350048WA, SR522350049WA, SR522350050WA, SR522350088WA, SR522350051WA, SR522350053WA, SR522350054WA, SR522350055WA, SR522350087WA, SR522350089WA, SR522350090WA, SR522350091WA, SR522350092WA, SR522350093WA, SR522350094WA, SR522350095WA, SR522350096WA, SR522350097WA, SR522350098WA, SR522350168WA, SR522350165WA, SR522350166WA, SR522350167WA, SR522350169WA, SR522350170WA, SR522350171WA, SR522350172WA, SR522350173WA, SR522350174WA, SR522350175WA, SR522350176WA, SR522350177WA, SR522350178WA, SR522350179WA, SR522350183WA, SR522350180WA, SR522350181WA, SR522350182WA, SR522350160WA, SR522350161WA, SR522350162WA, SR522350163WA, SR522350164WA, SR522350135WA, SR522350136WA, SR522350137WA, SR522350138WA, SR522350139WA, SR522350140WA, SR522350141WA, SR522350142WA, SR522350143WA, SR522350144WA, SR522350145WA, SR522350146WA, SR522350147WA, SR522350148WA, SR522350149WA, SR522350150WA, SR522350151WA, SR522350152WA, SR522350153WA, SR522350155WA, SR522350156WA, SR522350157WA, SR522350158WA, SR522350159WA, SR522350111WA, SR522350112WA, SR522350116WA, SR522350113WA, SR522350114WA, SR522350115WA, SR522350117WA, SR522350118WA, SR522350119WA, SR522350120WA, SR522350121WA, SR522350122WA, SR522350123WA, SR522350124WA, SR522350125WA, SR522350126WA, SR522350127WA, SR522350128WA, SR522350129WA, SR522350130WA, SR522350131WA, SR522350132WA, SR522350133WA, SR522350134WA, SR522350099WA, SR522350100WA, SR522350101WA, SR522350102WA, SR522350103WA, SR522350104WA, SR522350105WA, SR522350106WA, SR522350107WA, SR522350108WA, SR522350109WA, SR522350110WA, SR522350022WA, SR522350023WA, SR522350024WA, SR522350034WA, SR522350031WA, SR522350032WA, SR522350033WA, SR522350035WA, SR522350036WA, SR522350037WA, SR522350038WA, SR522350039WA, SR522350040WA, SR522350041WA, SR522350042WA, SR522350043WA, SR522350044WA, SR522350045WA, SR522350046WA, SR522350027WA, SR522350028WA, SR522350029WA, SR522350030WA, SR522350026WA, SR522350025WA; Model Number 6160000-002-100767, Serial Numbers: SR522340004WA, SR522340001WA, SR522340002WA, SR522340003WA, SR522340005WA, SR522340006WA, SR522340007WA, SR522340008WA, SR522340009WA, SR522340010WA; Model Number 6160000-002-101962, Serial Numbers: SR522380044WA, SR522380041WA, SR522380042WA, SR522380043WA, SR522380058WA, SR522380055WA, SR522380056WA, SR522380057WA, SR522380059WA, SR522380061WA, SR522380060WA, SR522380062WA, SR522380063WA, SR522380064WA, SR522380065WA, SR522380066WA, SR522380067WA, SR522380068WA, SR522380045WA, SR522380046WA, SR522380047WA, SR522380048WA, SR522380049WA, SR522380050WA, SR522380051WA, SR522380052WA, SR522380053WA, SR522380054WA, SR522380069WA, SR522380070WA, SR522380071WA, SR522380072WA, SR522380073WA, SR522380074WA, SR522380075WA, SR522380076WA, SR522380077WA, SR522380078WA, SR522380079WA, SR522380080WA, SR522380081WA, SR522380082WA, SR522380083WA, SR522380084WA, SR522380085WA, SR522380086WA, SR522380087WA, SR522380088WA, SR522380089WA, SR522380090WA, SR522380092WA, SR522380091WA, SR522380001WA, SR522380027WA, SR522380028WA, SR522380029WA, SR522380030WA, SR522380031WA, SR522380032WA, SR522380034WA, SR522380035WA, SR522380036WA, SR522380037WA, SR522380038WA, SR522380039WA, SR522380040WA, SR522380093WA, SR522380094WA, SR522380095WA, SR522380096WA, SR522380097WA, SR522380098WA, SR522380099WA, SR522380100WA, SR522380101WA, SR522380102WA, SR522380103WA, SR522380104WA, SR522380105WA, SR522380106WA, SR522380107WA, SR522380111WA, SR522380108WA, SR522380109WA, SR522380110WA, SR522380115WA, SR522380112WA, SR522380113WA, SR522380114WA, SR522380116WA; Model Number 6160000-002-753161, Serial Numbers: SR521070001WA, SR521040006WA, SR521040007WA, SR521050002WA, SR521050025WA, SR521050026WA, SR521050027WA, SR521050029WA, SR521050032WA, SR521050033WA, SR521050035WA, SR521050036WA, SR521050038WA, SR521040003WA, SR521050003WA, SR521050004WA, SR521050005WA, SR521050008WA, SR521070006WA, SR521050001WA, SR521050037WA, SR521070003WA, SR521070007WA, SR521040017WA, SR521040022WA, SR521040002WA, SR521040010WA, SR521050034WA, SR521040020WA, SR521050030WA, SR521040009WA, SR521040001WA, SR521040004WA, SR521040008WA, SR521040011WA, SR521040012WA, SR521040014WA, SR521040018WA, SR521070005WA, SR521070004WA, SR521040013WA, SR521040016WA, SR521040019WA, SR521040021WA, SR521040023WA, SR521040015WA, SR521050006WA, SR521050028WA, SR521050031WA, SR521070002WA; Model Number 6160000-002-767129, Serial Numbers: SR521110001WA, SR521110002WA, SR521110003WA, SR521110004WA, SR521110005WA; Model Number 6160000-002-790743, Serial Numbers: SR521230001WA, SR521230002WA, SR521230003WA, SR521230004WA, SR521230005WA, SR521230006WA, SR521300002WA, SR521410008WA, SR521410009WA, SR521410010WA, SR521150001WA, SR521150002WA, SR521150003WA, SR521150004WA, SR522080001WA, SR521260010WA, SR521260011WA, SR521260012WA, SR521260013WA, SR521260014WA, SR521260015WA, SR521220031WA, SR521220028WA, SR521220029WA, SR521220030WA, SR521220032WA, SR521220033WA, SR521220034WA, SR521220035WA, SR521220036WA, SR521220037WA, SR521220038WA, SR521220039WA, SR521450004WA, SR521450003WA, SR521450005WA, SR521460017WA, SR521460014WA, SR521460015WA, SR521460016WA, SR521460018WA, SR521150005WA, SR521300001WA, SR521410004WA, SR521410001WA, SR521410002WA, SR521410003WA, SR521410005WA, SR521410006WA, SR521410007WA, SR521410011WA, SR521450001WA, SR521450002WA, SR521470031WA, SR521470030WA, SR522350066WA, SR522350064WA, SR522350065WA; Model Number 6160000-002-791942, Serial Numbers: SR521150009WA, SR521150006WA, SR521150007WA, SR521150008WA, SR521150010WA, SR521150011WA; Model Number 6160000-002-795077, Serial Numbers: SR521220026WA; Model Number 6160000-002-807391, Serial Numbers: SR521400015WA, SR521400016WA, SR521400017WA, SR521400018WA, SR521400019WA, SR521400020WA, SR521400021WA, SR521400022WA, SR521400007WA, SR521400009WA, SR521400008WA, SR521400010WA, SR521400011WA, SR521200012WA, SR521200009WA, SR521200015WA, SR521200016WA, SR521200017WA, SR521200018WA, SR521200014WA, SR521200019WA, SR521200011WA, SR521200028WA, SR521200020WA, SR521400013WA, SR521200013WA, SR521400014WA, SR521200010WA, SR521400012WA, SR521200021WA, SR521200022WA, SR521200023WA, SR521200027WA, SR521200024WA, SR521200025WA, SR521200026WA, SR521400004WA, SR521400005WA, SR521400006WA; Model Number 6160000-002-811089, Serial Numbers: SR521220005WA, SR521220006WA, SR521220007WA, SR521220008WA, SR521220009WA, SR521220010WA, SR521220011WA; Model Number 6160000-002-813390, Serial Numbers: SR521220012WA, SR521220013WA, SR521220014WA, SR521370012WA; Model Number 6160000-002-815200, Serial Numbers: SR521200040WA, SR521200046WA, SR521200048WA, SR521200049WA, SR521200045WA, SR521200050WA, SR521200051WA, SR521200053WA, SR521210001WA, SR521210003WA, SR521200041WA, SR521200042WA, SR521200043WA, SR521200047WA, SR521200044WA, SR521200039WA, SR521200055WA, SR521200057WA, SR521210002WA, SR521200052WA, SR521200054WA, SR521200056WA; Model Number 6160000-002-816411, Serial Numbers: SR521220015WA, SR521220016WA, SR521220017WA, SR521220018WA; Model Number 6160000-002-818359, Serial Numbers: SR521210011WA, SR521210012WA, SR521210013WA, SR521210014WA; Model Number 6160000-002-832284, Serial Numbers: SR521260001WA, SR521260002WA, SR521260003WA; Model Number 6160000-002-841595, Serial Numbers: SR521270053WA, SR521270051WA, SR521270052WA, SR521270054WA, SR521270055WA, SR521270056WA, SR521270057WA, SR521270058WA, SR521270059WA, SR521270060WA, SR521270038WA, SR521270035WA, SR521270036WA, SR521270037WA, SR521270039WA, SR521270040WA, SR521270041WA, SR521270042WA, SR521270043WA, SR521270044WA, SR521270045WA, SR521270046WA, SR521270047WA, SR521270048WA, SR521270049WA, SR521270019WA, SR521270016WA, SR521270017WA, SR521270018WA, SR521270020WA, SR521270021WA, SR521270022WA, SR521270023WA, SR521270027WA, SR521270029WA, SR521270030WA, SR521270031WA, SR521270032WA, SR521270033WA, SR521270034WA, SR521270050WA, SR521270026WA, SR521270028WA, SR521270024WA, SR521270025WA; Model Number 6160000-002-849738, Serial Numbers: SR521280006WA; Model Number 6160000-002-870236, Serial Numbers: SR521370042WA; Model Number 6160000-002-870818, Serial Numbers: SR521370043WA; Model Number 6160000-002-874089, Serial Numbers: SR521380015WA, SR521380013WA, SR521380014WA; Model Number 6160000-002-874722, Serial Numbers: SR521400003WA; Model Number 6160000-002-905758, Serial Numbers: SR521460049WA, SR521460050WA, SR521460051WA; Model Number 6160000-002-906055, Serial Numbers: SR521470022WA; Model Number 6160000-002-912058, Serial Numbers: SR521470072WA, SR521470073WA, SR521470074WA, SR521470075WA, SR521470076WA, SR521470077WA, SR521470078WA; Model Number 6160000-002-912766, Serial Numbers: SR521460035WA, SR521460036WA, SR521460037WA, SR521460038WA, SR521460039WA, SR521460040WA, SR521460041WA, SR521460042WA, SR521460043WA, SR521460020WA, SR521460026WA, SR521460033WA, SR521460030WA, SR521460021WA, SR521460022WA, SR521460028WA, SR521460032WA, SR521460034WA, SR521460003WA, SR521460004WA, SR521460005WA, SR521460006WA, SR521460007WA, SR521460008WA, SR521460009WA, SR521460010WA, SR521460011WA, SR521460012WA, SR521460024WA, SR521460025WA, SR521460031WA, SR521460027WA, SR521460029WA, SR521460013WA, SR521460023WA; Model Number 6160000-002-914630, Serial Numbers: SR522190006WA, SR522190007WA, SR522190008WA, SR522190009WA, SR522190010WA, SR521470042WA, SR521470043WA; Model Number 6160000-002-935475, Serial Numbers: SR521490001WA; Model Number 6160000-002-943015, Serial Numbers: SR521500004WA, SR521500001WA, SR521500002WA, SR521500003WA, SR521500005WA, SR521500006WA, SR521500007WA, SR521500008WA, SR521500009WA, SR521500010WA, SR521500011WA, SR521500012WA, SR521500013WA, SR521500014WA, SR521500015WA; Model Number 6160000-002-943237, Serial Numbers: SR522350057WA; Model Number 6160000-002-962992, Serial Numbers: SR522110003WA, SR522110002WA, SR522110001WA; Model Number 6160000-002-972536, Serial Numbers: SR522110022WA, SR522110019WA, SR522110020WA, SR522110021WA, SR522110023WA, SR522110024WA, SR522110025WA, SR522110026WA, SR522110027WA, SR522110028WA, SR522110029WA, SR522110030WA, SR522110031WA, SR522110032WA, SR522110033WA, SR522110034WA, SR522110035WA, SR522110036WA, SR522110037WA, SR522110038WA, SR522110039WA, SR522110040WA, SR522110041WA, SR522110042WA, SR522110043WA, SR522110044WA, SR522110045WA, SR522110046WA, SR522110047WA, SR522110048WA, SR522110052WA, SR522110049WA, SR522110050WA, SR522110051WA, SR522110053WA, SR522110091WA, SR522110088WA, SR522110089WA, SR522110090WA, SR522110092WA, SR522110093WA, SR522110094WA, SR522110095WA, SR522110096WA, SR522110097WA, SR522110098WA, SR522110099WA, SR522110100WA, SR522110101WA, SR522110102WA, SR522110103WA, SR522110104WA, SR522110105WA, SR522110106WA, SR522110107WA, SR522110108WA, SR522110109WA, SR522110110WA, SR522110111WA, SR522110112WA, SR522110113WA, SR522110007WA, SR522110004WA, SR522110005WA, SR522110006WA, SR522110008WA, SR522110009WA, SR522110010WA, SR522110011WA, SR522110012WA, SR522110016WA, SR522110013WA, SR522110014WA, SR522110015WA, SR522110017WA, SR522110018WA, SR522110057WA, SR522110054WA, SR522110055WA, SR522110056WA, SR522110058WA, SR522110059WA, SR522110060WA, SR522110061WA, SR522110062WA, SR522110063WA, SR522110064WA, SR522110065WA, SR522110066WA, SR522110067WA, SR522110068WA, SR522110069WA, SR522110070WA, SR522110071WA, SR522110072WA, SR522110073WA, SR522110074WA, SR522110075WA, SR522110076WA, SR522110077WA, SR522110078WA, SR522110079WA, SR522110080WA, SR522110081WA, SR522110082WA, SR522110083WA, SR522110087WA, SR522110084WA, SR522110085WA, SR522110086WA.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0730-2023

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