Z-1488-2022Class I

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF...

Name: Z-1488-2022 Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2022-06-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-06-22 / Open, Classified / root cause: design

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt... on 2022-06-22. FDA classified it as Class I and gives the reason as "There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1488-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-06-22
Posted: 2022-08-09
Recalling firm: Medtronic, Inc.
Product: Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Root cause tag: design
FDA root cause: Device Design
Action: Beginning 22-JUN-2022 communications to all affected consignees began. In the United States notifications are sent via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification. Consignees are asked to quarantine the subset of unused identified Cobalt and Crome devices for retrieval due to potential manufacturing non-conformance and return the inventory to Medtronic. On approximately 08/10/2022, Medtronic notified Risk Managers of the availability of a SW update and actions specific to update the SW on the SmartSync devices, that will in turn update the patient's implanted device during their next clinic visit. In addition, on this same date, a separate communication dated August 2022 is being sent to all affected Implanting Physicians notifying them that a SW update is available and recommended actions to correct this issue with their patient's implanted device. The second notification to physicians did not request returned confirmation.
Quantity in commerce: 1408 units
Distribution: Worldwide Distribution
Product codes and lots: a. Model Numbers: DTPB2D4: GTIN 00763000178215, Serial Numbers: RTO600239S, RTO600280S, RTO600409S, RTO600468S, RTO600544S, RTO600701S, RTO600712S, RTO601012S, RTO601031S, RTO601113S, RTO601150S, RTO601156S, RTO601205S, RTO601223S, RTO601549S, RTO601612S, RTO601620S, RTO601784S, RTO601793S, RTO601819S, RTO601823S, RTO601830S, RTO601845S, RTO601846S, RTO601858S, RTO601860S, RTO601862S, RTO601891S, RTO601905S, RTO601945S, RTO601960S, RTO601965S, RTO601986S, RTO602000S, RTO602002S, RTO602029S, RTO602031S, RTO602056S, RTO602107S, RTO602110S, RTO602116S, RTO602159S, RTO602164S, RTO602173S, RTO602183S, RTO602224S, RTO602260S, RTO602261S, RTO602266S, RTO602297S, RTO602303S, RTO602308S, RTO602311S, RTO602324S, RTO602326S, RTO602330S, RTO602331S, RTO602333S, RTO602336S, RTO602340S, RTO602354S, RTO602362S, RTO602372S, RTO602375S, RTO602427S, RTO602431S, RTO602435S, RTO602447S, RTO602452S, RTO602468S, RTO602479S, RTO602487S, RTO602493S, RTO602513S, RTO602516S, RTO602520S, RTO602524S, RTO602536S, RTO602544S, RTO602545S, RTO602556S, RTO602562S, RTO602568S, RTO602577S, RTO602578S, RTO602596S, RTO602598S, RTO602600S; GTIN 00763000178239, Serial Numbers: RTO600028S, RTO600029S, RTO600030S, RTO600031S, RTO600033S, RTO600034S, RTO600036S, RTO600037S, RTO600038S, RTO600040S, RTO600041S, RTO600042S, RTO600043S, RTO600045S, RTO600046S, RTO600047S, RTO600048S, RTO600049S, RTO600050S, RTO600051S, RTO600052S, RTO600053S, RTO600054S, RTO600055S, RTO600056S, RTO600057S, RTO600058S, RTO600060S, RTO600061S, RTO600062S, RTO600064S, RTO600067S, RTO600069S, RTO600070S, RTO600136S, RTO600606S, RTO600906S, RTO600960S, RTO600966S, RTO600967S, RTO600970S, RTO600971S, RTO600972S, RTO600973S, RTO600974S, RTO600975S, RTO600977S, RTO600978S, RTO600980S, RTO600983S, RTO600984S, RTO600985S, RTO600986S, RTO600988S, RTO600989S, RTO601010S, RTO601016S, RTO601018S, RTO601022S, RTO601077S, RTO601092S, RTO601099S, RTO601104S, RTO601133S, RTO601162S, RTO601164S, RTO601168S, RTO601172S, RTO601185S, RTO601211S, RTO601217S, RTO601226S, RTO601233S, RTO601241S, RTO601251S, RTO601252S, RTO601253S, RTO601254S, RTO601256S, RTO601257S, RTO601258S, RTO601264S, RTO601265S, RTO601267S, RTO601268S, RTO601269S, RTO601274S, RTO601278S, RTO601280S, RTO601281S, RTO601284S, RTO601290S, RTO601291S, RTO601292S, RTO601298S, RTO601300S, RTO601323S, RTO601333S, RTO601338S, RTO601342S, RTO601344S, RTO601345S, RTO601360S, RTO601364S, RTO601365S, RTO601369S, RTO601370S, RTO601371S, RTO601374S, RTO601379S, RTO601386S, RTO601392S, RTO601393S, RTO601396S, RTO601397S, RTO601398S, RTO601399S, RTO601400S, RTO601402S, RTO601403S, RTO601405S, RTO601411S, RTO601414S, RTO601415S, RTO601440S, RTO601442S, RTO601444S, RTO601462S, RTO601466S, RTO601467S, RTO601957S, RTO601976S, RTO602187S, RTO602216S, RTO602219S, RTO602220S, RTO602222S, RTO602223S, RTO602226S, RTO602228S, RTO602229S, RTO602232S, RTO602233S, RTO602234S, RTO602237S, RTO602238S, RTO602239S, RTO602240S, RTO602241S, RTO602242S, RTO602243S, RTO602245S, RTO602246S, RTO602247S, RTO602248S, RTO602250S, RTO602251S, RTO602253S, RTO602254S, RTO602255S, RTO602272S, RTO602299S, RTO602306S, RTO602313S, RTO602328S, RTO602332S, RTO602349S, RTO602378S, RTO602412S, RTO602414S, RTO602415S, RTO602419S, RTO602420S, RTO602430S, RTO602449S, RTO602450S, RTO602454S, RTO602473S, RTO602481S, RTO602494S, RTO602497S, RTO602500S, RTO602504S, RTO602505S; DTPB2D1: GTIN 00763000178222, Serial Numbers: RTP600231S, RTP600637S, RTP600821S, RTP600936S, RTP600949S, RTP601207S, RTP601642S, RTP601651S, RTP601655S, RTP601658S, RTP601669S, RTP601684S, RTP601772S, RTP601786S, RTP601803S, RTP601838S, RTP601839S, RTP601873S, RTP601908S, RTP601950S, RTP601967S, RTP601975S, RTP601985S, RTP602018S, RTP602050S, RTP602065S, RTP602067S, RTP602101S, RTP602113S, RTP602138S, RTP602141S, RTP602142S, RTP602143S, RTP602144S, RTP602173S, RTP602187S, RTP602188S, RTP602189S, RTP602195S, RTP602203S, RTP602212S, RTP602213S, RTP602221S, RTP602222S, RTP602253S, RTP602255S, RTP602277S, RTP602290S, RTP602291S, RTP602296S, RTP602298S, RTP602301S, RTP602303S, RTP602308S, RTP602313S, RTP602329S, RTP602333S, RTP602372S, RTP602379S, RTP602380S, RTP602381S, RTP602382S, RTP602383S, RTP602384S, RTP602390S, RTP602392S, RTP602408S, RTP602427S, RTP602428S, RTP602429S, RTP602430S, RTP602431S, RTP602433S, RTP602440S, RTP602441S, RTP602445S, RTP602456S, RTP602461S, RTP602471S, RTP602472S, RTP602491S, RTP602492S, RTP602496S, RTP602497S, RTP602500S, RTP602503S, RTP602523S; GTIN 00763000178246, Serial Numbers: RTP600011S, RTP600013S, RTP600014S, RTP600015S, RTP600022S, RTP600023S, RTP600024S, RTP600025S, RTP600026S, RTP600027S, RTP600028S, RTP600029S, RTP600032S, RTP600035S, RTP600037S, RTP600039S, RTP600043S, RTP600044S, RTP600045S, RTP600046S, RTP600047S, RTP600049S, RTP600051S, RTP600055S, RTP600056S, RTP600058S, RTP600061S, RTP600062S, RTP600064S, RTP600265S, RTP600318S, RTP600325S, RTP600337S, RTP600363S, RTP600364S, RTP600365S, RTP600367S, RTP600369S, RTP600370S, RTP600371S, RTP600376S, RTP601365S, RTP601366S, RTP601367S, RTP601368S, RTP601369S, RTP601370S, RTP601371S, RTP601374S, RTP601375S, RTP601376S, RTP601377S, RTP601378S, RTP601379S, RTP601380S, RTP601381S, RTP601382S, RTP601383S, RTP601384S, RTP601385S, RTP601386S, RTP601387S, RTP601388S, RTP601389S, RTP601390S, RTP601391S, RTP601392S, RTP601393S, RTP601394S, RTP601395S, RTP601396S, RTP601398S, RTP601403S, RTP601404S, RTP601405S, RTP601408S, RTP601409S, RTP601410S, RTP601411S, RTP601412S, RTP601414S, RTP601418S, RTP601419S, RTP601423S, RTP601424S, RTP601425S, RTP601426S, RTP601434S, RTP601443S, RTP601444S, RTP601446S, RTP601447S, RTP601449S, RTP601452S, RTP601453S, RTP601454S, RTP601457S, RTP601458S, RTP601459S, RTP601460S, RTP601461S, RTP601462S, RTP601464S, RTP601467S, RTP601470S, RTP601483S, RTP601485S, RTP601489S, RTP601491S, RTP601492S, RTP601496S, RTP601501S, RTP601504S, RTP601505S, RTP601511S, RTP601512S, RTP601513S, RTP601514S, RTP601516S, RTP601518S, RTP601524S, RTP601534S, RTP601539S; b. Model Numbers: DTPB2QQ: GTIN 00763000178178, Serial Numbers: RTK600618S, RTK600835S, RTK601828S, RTK602459S, RTK602776S, RTK602784S, RTK602799S, RTK602818S, RTK602951S, RTK603433S, RTK603475S, RTK603527S, RTK603528S, RTK604363S, RTK604481S, RTK604905S, RTK604930S, RTK604946S, RTK605316S, RTK605413S, RTK605674S, RTK605677S, RTK605685S, RTK605700S, RTK605703S, RTK605708S, RTK605710S, RTK605713S, RTK605714S, RTK605718S, RTK605722S, RTK605794S, RTK605833S, RTK605845S, RTK605848S, RTK605946S, RTK606126S, RTK606418S, RTK606497S, RTK606521S, RTK606803S, RTK606947S, RTK607461S, RTK607582S, RTK607652S, RTK608200S, RTK608230S, RTK608281S, RTK608312S, RTK608428S, RTK608654S, RTK608660S, RTK608677S, RTK608684S, RTK608694S, RTK608698S, RTK608703S, RTK608756S, RTK608774S, RTK608786S, RTK608910S, RTK608911S, RTK608925S, RTK609244S, RTK609484S, RTK609500S, RTK609501S, RTK609502S, RTK609553S, RTK609558S, RTK609561S, RTK609565S, RTK609566S, RTK609567S, RTK609568S, RTK609577S, RTK609589S, RTK609600S, RTK609725S, RTK609774S, RTK609780S, RTK609781S, RTK609782S, RTK609783S, RTK609784S, RTK609785S, RTK609786S, RTK609787S, RTK609791S, RTK609821S, RTK609959S, RTK609972S, RTK609975S, RTK609977S, RTK609978S, RTK610044S, RTK610108S; GTIN 00763000178192, Serial Numbers: RTK600014S, RTK600015S, RTK600023S, RTK600024S, RTK600026S, RTK600027S, RTK600028S, RTK600029S, RTK600030S, RTK600031S, RTK600032S, RTK600033S, RTK600034S, RTK600035S, RTK600037S, RTK600038S, RTK600039S, RTK600041S, RTK600042S, RTK600043S, RTK600044S, RTK600045S, RTK600048S, RTK600050S, RTK600051S, RTK600052S, RTK600053S, RTK600054S, RTK600055S, RTK600056S, RTK600057S, RTK600058S, RTK600059S, RTK600060S, RTK600061S, RTK600062S, RTK600063S, RTK600064S, RTK600065S, RTK600066S, RTK600067S, RTK600068S, RTK600070S, RTK600071S, RTK600072S, RTK600073S, RTK600082S, RTK600083S, RTK600084S, RTK600085S, RTK600086S, RTK600087S, RTK600088S, RTK600089S, RTK600092S, RTK600093S, RTK600094S, RTK600095S, RTK600096S, RTK600097S, RTK600098S, RTK600099S.RTK600100S, RTK600300S, RTK600301S, RTK600303S, RTK600304S, RTK600310S, RTK600311S, RTK600316S, RTK600317S, RTK600318S, RTK600319S, RTK600321S, RTK600322S, RTK600323S, RTK600325S, RTK600327S, RTK600328S, RTK600330S, RTK600331S, RTK600335S, RTK601049S, RTK601341S, RTK601371S, RTK601372S, RTK601379S, RTK601441S, RTK601854S, RTK601858S, RTK601860S, RTK601861S, RTK601862S, RTK601868S, RTK601884S, RTK601885S, RTK601919S, RTK602063S, RTK602064S, RTK602073S, RTK602074S, RTK602075S, RTK602078S, RTK602082S, RTK602084S, RTK602085S, RTK602087S, RTK602091S, RTK602093S, RTK602094S, RTK602098S, RTK602100S, RTK602101S, RTK602102S, RTK602103S, RTK602118S, RTK602123S, RTK602125S, RTK602144S, RTK602145S, RTK602151S, RTK602152S, RTK602154S, RTK602161S, RTK602171S, RTK602181S, RTK602187S, RTK602191S, RTK602194S, RTK602211S, RTK602215S, RTK602216S, RTK602232S, RTK602246S, RTK602363S, RTK602364S, RTK602404S, RTK602542S, RTK602543S, RTK602544S, RTK602545S, RTK602551S, RTK602552S, RTK602554S, RTK602562S, RTK602563S, RTK602571S, RTK602579S, RTK602580S, RTK602587S, RTK602591S, RTK602596S, RTK602602S, RTK602603S, RTK603520S, RTK603536S, RTK603539S, RTK603541S, RTK603547S, RTK603550S, RTK603551S, RTK603557S, RTK603561S, RTK603564S, RTK603565S, RTK603568S, RTK603571S, RTK603574S, RTK603585S, RTK603592S, RTK603594S, RTK603596S, RTK603598S, RTK603606S, RTK603614S, RTK603616S, RTK603617S, RTK603618S, RTK603621S, RTK603622S, RTK603627S, RTK603628S, RTK603629S, RTK603631S, RTK603634S, RTK603636S, RTK603639S, RTK603641S, RTK603653S, RTK603661S, RTK603666S, RTK603673S, RTK603675S, RTK603676S, RTK603677S, RTK603678S, RTK603682S, RTK603684S, RTK603689S, RTK603693S, RTK603699S, RTK603707S, RTK603714S, RTK603724S, RTK603726S, RTK603728S, RTK603730S, RTK603731S, RTK603732S, RTK603733S, RTK603735S, RTK603736S, RTK603737S, RTK603743S, RTK603744S, RTK603745S, RTK603747S, RTK603748S, RTK603750S, RTK603752S, RTK603760S, RTK603766S, RTK603767S, RTK603776S, RTK603807S, RTK603808S, RTK603818S, RTK603835S, RTK603862S, RTK603864S, RTK603876S, RTK604017S, RTK604082S, RTK604146S, RTK604163S, RTK604164S, RTK604169S, RTK604171S, RTK604172S, RTK604177S, RTK604182S, RTK604183S, RTK604185S, RTK604224S, RTK604225S, RTK604228S, RTK604231S, RTK604240S, RTK604241S, RTK604244S, RTK604246S, RTK604254S, RTK604257S, RTK604264S, RTK604266S, RTK604267S, RTK604268S, RTK604269S, RTK604270S, RTK604272S, RTK604273S, RTK604274S, RTK604275S, RTK604283S, RTK604284S, RTK604285S, RTK604286S, RTK604287S, RTK604288S, RTK604289S, RTK604290S, RTK604291S, RTK604292S, RTK604293S, RTK604294S, RTK604295S, RTK604296S, RTK604297S, RTK604299S, RTK604300S, RTK604301S, RTK604302S, RTK604303S, RTK604304S, RTK604305S, RTK604306S, RTK604307S, RTK604308S, RTK604309S, RTK604310S, RTK604311S, RTK604312S, RTK604313S, RTK604314S, RTK604315S, RTK604316S, RTK604317S, RTK604318S, RTK604319S, RTK604320S, RTK604321S, RTK604322S, RTK604323S, RTK604324S, RTK604325S, RTK604326S, RTK604327S, RTK604328S, RTK604329S, RTK604332S, RTK604567S, RTK604620S, RTK604624S, RTK604667S, RTK604714S, RTK604729S, RTK604734S, RTK604746S, RTK604748S, RTK604752S, RTK604754S, RTK604756S, RTK604761S, RTK604763S, RTK604765S, RTK604766S, RTK604771S, RTK604772S, RTK604773S, RTK604774S, RTK604775S, RTK604776S, RTK604778S, RTK604779S, RTK604780S, RTK604782S, RTK604783S, RTK604784S, RTK604785S, RTK604786S, RTK604787S, RTK604788S, RTK604789S, RTK604790S, RTK604791S, RTK604795S, RTK604796S, RTK604797S, RTK604798S, RTK604803S, RTK604806S, RTK604810S, RTK604812S, RTK604815S, RTK604820S, RTK604822S, RTK604823S, RTK604828S, RTK604829S, RTK604844S, RTK604845S, RTK605119S, RTK605120S, RTK605125S, RTK605126S, RTK605127S, RTK605128S, RTK605131S, RTK605132S, RTK605134S, RTK605137S, RTK605138S, RTK605141S, RTK605143S, RTK605145S, RTK605148S, RTK605150S, RTK605151S, RTK605154S, RTK605157S, RTK605158S, RTK605159S, RTK605160S, RTK605161S, RTK605162S, RTK605163S, RTK605165S, RTK605167S, RTK605170S, RTK605172S, RTK605181S, RTK605188S, RTK605192S, RTK605206S, RTK605213S, RTK605256S, RTK605324S, RTK605335S, RTK605338S, RTK605361S, RTK605373S, RTK605381S, RTK605383S, RTK605393S, RTK605417S, RTK605466S, RTK605470S, RTK605485S, RTK605492S, RTK605676S, RTK605951S, RTK606196S, RTK606205S, RTK606256S, RTK606443S, RTK606522S, RTK606526S, RTK606557S, RTK606567S, RTK606572S, RTK606589S, RTK606599S, RTK606613S, RTK606614S, RTK606619S, RTK606620S, RTK606621S, RTK606626S, RTK606627S, RTK606628S, RTK606657S, RTK606662S, RTK606688S, RTK606689S, RTK606693S, RTK606694S, RTK606699S, RTK606712S, RTK606748S, RTK606759S, RTK606784S, RTK606787S, RTK606788S, RTK606814S, RTK606820S, RTK606833S, RTK606837S, RTK606851S, RTK606864S, RTK606996S, RTK607036S, RTK607152S, RTK607154S, RTK607223S, RTK607324S, RTK607554S, RTK607661S, RTK607665S, RTK607675S, RTK607720S, RTK607727S, RTK607731S, RTK607760S, RTK607761S, RTK607764S, RTK607765S, RTK607766S, RTK607772S, RTK607776S, RTK607782S, RTK607787S, RTK607802S, RTK607807S, RTK607811S, RTK607828S, RTK607829S, RTK607830S, RTK607831S, RTK607834S, RTK607835S, RTK607836S, RTK607838S, RTK607840S, RTK607842S, RTK607843S, RTK607844S, RTK607845S, RTK607847S, RTK607852S, RTK607866S, RTK607871S, RTK607874S, RTK607876S, RTK607877S, RTK607881S, RTK607882S, RTK607890S, RTK607892S, RTK607903S, RTK607927S, RTK607928S, RTK607931S, RTK607935S, RTK607943S, RTK607946S, RTK607948S, RTK607950S, RTK607951S, RTK607952S, RTK607964S, RTK607970S, RTK607972S, RTK607973S, RTK607974S, RTK607978S, RTK607980S, RTK607983S, RTK607984S, RTK607988S, RTK607993S, RTK607995S, RTK607997S, RTK607998S, RTK607999S, RTK608971S, RTK609002S, RTK609093S, RTK609487S, RTK609493S, RTK609496S, RTK609499S, RTK609512S, RTK609517S, RTK609527S, RTK609557S, RTK609559S, RTK609560S, RTK609562S, RTK609564S, RTK609570S, RTK609571S, RTK609572S, RTK609574S, RTK609576S, RTK609580S, RTK609581S, RTK609588S, RTK609605S, RTK609606S, RTK609607S, RTK609608S, RTK609611S, RTK609613S, RTK609614S, RTK609615S, RTK609617S, RTK609684S, RTK609687S, RTK609710S, RTK609855S, RTK609888S, RTK609897S, RTK609899S, RTK609921S, RTK609924S, RTK609937S, RTK609947S, RTK609948S, RTK609950S, RTK609951S, RTK609952S, RTK609955S, RTK609960S, RTK609962S, RTK609963S, RTK609964S, RTK609966S, RTK609967S, RTK609968S, RTK609969S, RTK609970S, RTK609973S, RTK609974S, RTK609976S, RTK609979S, RTK609980S, RTK609983S, RTK609984S, RTK609987S, RTK609990S, RTK609995S, RTK609999S, RTK610008S, RTK610011S, RTK610013S, RTK610018S, RTK610019S, RTK610022S, RTK610023S, RTK610027S, RTK610028S, RTK610029S, RTK610031S, RTK612662S, RTK612665S; DTPB2Q1: GTIN 00763000178185, Serial Numbers: RTL600106S, RTL600179S, RTL600278S, RTL600345S, RTL600518S, RTL600524S, RTL600756S, RTL600786S, RTL600788S, RTL600802S, RTL600845S, RTL600979S, RTL601099S, RTL601105S, RTL601116S, RTL601128S, RTL601131S, RTL601166S, RTL601169S, RTL601177S, RTL601196S, RTL601199S, RTL601242S, RTL601250S, RTL601284S, RTL601316S, RTL601322S, RTL601325S, RTL601326S, RTL601339S, RTL601344S, RTL601345S, RTL601364S, RTL601368S, RTL601386S, RTL601391S, RTL601402S, RTL601408S, RTL601410S, RTL601423S, RTL601424S, RTL601427S, RTL601432S, RTL601439S, RTL601440S, RTL601474S, RTL601478S, RTL601480S, RTL601482S, RTL601488S, RTL601490S, RTL601491S, RTL601495S, RTL601507S, RTL601536S, RTL601549S, RTL601554S, RTL601574S, RTL601576S, RTL601585S, RTL601595S, RTL601601S, RTL601609S, RTL601616S, RTL601619S, RTL601621S, RTL601630S, RTL601639S, RTL601641S, RTL601643S, RTL601648S, RTL601660S, RTL601661S, RTL601664S, RTL601676S, RTL601679S, RTL601682S, RTL601687S, RTL601705S, RTL601706S, RTL601707S, RTL601708S, RTL601711S, RTL601715S, RTL601723S, RTL601729S, RTL601731S, RTL601732S, RTL601735S, RTL601736S, RTL601753S, RTL601760S, RTL601762S, RTL601764S, RTL601767S, RTL601772S, RTL601776S, RTL601777S, RTL601778S, RTL601779S, RTL601789S, RTL601801S, RTL601809S, RTL601812S, RTL601815S, RTL601816S, RTL601820S, RTL601821S, RTL601825S, RTL601826S, RTL601829S, RTL601830S, RTL601832S, RTL601850S, RTL601852S, RTL601857S, RTL601859S, RTL601862S, RTL601864S, RTL601873S, RTL601876S, RTL601877S, RTL601878S, RTL601879S, RTL601880S, RTL601881S, RTL601882S, RTL601883S, RTL601884S, RTL601885S, RTL601888S, RTL601890S, RTL601891S, RTL601892S, RTL601893S, RTL601894S, RTL601896S, RTL601912S; GTIN 00763000178208, Serial Numbers: RTL600005S, RTL600007S, RTL600008S, RTL600010S, RTL600014S, RTL600017S, RTL600022S, RTL600023S, RTL600027S, RTL600030S, RTL600032S, RTL600036S, RTL600037S, RTL600038S, RTL600040S, RTL600042S, RTL600043S, RTL600044S, RTL600050S, RTL600069S, RTL600071S, RTL600072S, RTL600074S, RTL600076S, RTL600079S, RTL600086S, RTL600096S, RTL600097S, RTL600098S, RTL600099S, RTL600100S, RTL600102S, RTL600103S, RTL600970S, RTL600973S, RTL600981S, RTL600984S, RTL600993S, RTL601004S, RTL601018S, RTL601028S, RTL601037S, RTL601043S, RTL601047S, RTL601285S, RTL601447S, RTL601448S, RTL601479S, RTL601499S, RTL601503S, RTL601504S, RTL601505S, RTL601509S, RTL601511S, RTL601514S, RTL601515S, RTL601518S, RTL601519S, RTL601521S, RTL601525S, RTL601529S, RTL601539S, RTL601548S, RTL601578S, RTL601580S, RTL601581S, RTL601625S, RTL601626S, RTL601628S, RTL601633S, RTL601635S, RTL601645S, RTL601655S, RTL601657S, RTL601717S, RTL601725S, RTL601742S, RTL601743S, RTL601748S, RTL601749S, RTL601750S, RTL601751S, RTL601752S, RTL601754S, RTL601755S, RTL601759S.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1488-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1485-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08
Z-1486-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08
Z-1487-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08
Z-1488-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08
Z-1489-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08
Z-1490-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-08

Product code NIK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)