Recall archive / FDA device enforcement
Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a ... — FDA record Z-0453-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 26, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 to include: CARESCAPE B450 MBA313 2095800-001 CARESCAPE MONITOR B450 (ATO MODEL) 2068491-002 CARESCAPE MONITOR B450 B1 2107633-001 CARESCAPE MONITOR B450-GS (V2.0.8) 2094080-001
- Reason
- Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
- Classification
- Class II
- Recalling firm
- GE Healthcare Finland Oy
- Quantity
- 3271
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0453-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 00840682146135 Serial numbers SNT25079613SA SNT25079608SA SNT25079622SA SNT25079618SA SNT25079619SA SNT25079614SA SNT25079611SA SNT25079621SA SNT25079620SA SNT25079603SA SNT25079616SA SNT25079612SA SNT25079602SA SNT25079615SA SNT25079663SA SNT25079664SA SNT25079677SA SNT25079662SA SNT25079667SA SNT25079678SA SNT25079680SA SNT25079666SA SNT25079695SA SNT25079694SA SNT25079697SA SNT25079688SA SNT25079687SA SNT25079685SA SNT25079676SA SNT25079674SA SNT25079671SA SNT25079691SA SNT25079689SA SNT25079679SA SNT25079681SA SNT25079684SA SNT25079672SA SNT25079668SA SNT25079665SA SNT25079675SA SNT25079693SA SNT25069004SA SNT25069001SA SNT25069002SA SNT25069003SA SNT25069013SA SNT25069007SA SNT25069015SA SNT25069012SA SNT25069014SA SNT25069016SA SNT25069017SA SNT25069021SA SNT25069019SA SNT25069006SA SNT25069020SA SNT25069005SA SNT25069008SA SNT25069009SA SNT25069018SA SNT25069023SA SNT25259594SA SNT25259577SA SNT25259590SA SNT25069508SA SNT25069564SA SNT25219502SA SNT25219501SA SNT25219504SA SNT25219503SA SNT25079536SA SNT25079537SA SNT25079558SA SNT25079532SA SNT25079569SA SNT25079539SA SNT25079526SA SNT25079571SA SNT25079575SA SNT25079576SA SNT25079572SA SNT25079574SA SNT25079533SA SNT25079524SA SNT25079573SA SNT24429994SA SNT25149512SA SNT25149514SA SNT25109580SA SNT25109578SA SNT25109576SA SNT25109579SA SNT25109577SA SNT25109574SA SNT25109575SA SNT25109581SA SNT25109573SA SNT25179587SA SNT25179583SA SNT25179577SA SNT25179573SA SNT25179574SA SNT25019477SA SNT24529475SA SNT24529472SA SNT25019494SA SNT25099727SA SNT25099728SA SNT25099729SA SNT25099730SA SNT25099732SA SNT25099733SA SNT25099736SA SNT25099735SA SNT25099737SA SNT25099738SA SNT25109521SA SNT25109514SA SNT25199525SA SNT25199527SA SNT25199528SA SNT25199519SA SNT25199521SA SNT25199526SA SNT25199524SA SNT25199540SA SNT25089012SA SNT25259570SA SNT25269581SA SNT25269583SA SNT25269582SA SNT25269589SA SNT25269591SA SNT25269588SA SNT25269594SA SNT25269599SA SNT25269596SA SNT25269593SA SNT25159685SA SNT24529627SA SNT25019502SA SNT25149516SA SNT25149520SA SNT25149519SA SNT25149521SA SNT25149525SA SNT25249599SA SNT25249600SA SNT25249602SA SNT25249023SA SNT25249017SA SNT25249008SA SNT25249022SA SNT25249028SA SNT25249018SA SNT25249016SA SNT25249020SA SNT25249021SA SNT25249009SA SNT25249019SA SNT25249014SA SNT25249029SA SNT25249026SA SNT25169503SA SNT25169504SA SNT25149508SA SNT25149507SA SNT25149503SA SNT25149502SA SNT25289014SA SNT25289016SA SNT25289018SA SNT25289017SA SNT25289019SA SNT25289020SA SNT25289021SA SNT25289022SA SNT25289026SA SNT25289024SA SNT25289025SA SNT25289023SA SNT25289027SA SNT25289028SA SNT25289030SA SNT25289031SA SNT25289032SA SNT25289029SA SNT25289035SA SNT25289034SA SNT25289033SA SNT25289038SA SNT25289037SA SNT25289036SA SNT25289013SA SNT25289039SA SNT25289042SA SNT25289040SA SNT25289015SA SNT25289052SA SNT25289049SA SNT25289046SA SNT25289053SA SNT25289054SA SNT25289050SA SNT25289045SA SNT25289048SA SNT25289051SA SNT25289043SA SNT25289044SA SNT25289041SA SNT25289047SA SNT24529471SA SNT25019479SA SNT25119501SA SNT25159687SA SNT25199564SA SNT25199600SA SNT25199568SA SNT25249560SA SNT25249557SA SNT25249559SA SNT25249571SA SNT25249567SA SNT25249569SA SNT25249533SA SNT25249572SA SNT25249573SA SNT25249575SA SNT25249568SA SNT25249556SA SNT25249565SA SNT25249570SA SNT25249574SA SNT25249506SA SNT25249564SA SNT25249576SA SNT25249555SA SNT25249554SA SNT25249581SA SNT25249596SA SNT25249592SA SNT25249597SA SNT25249595SA SNT25249601SA SNT25249591SA SNT24206039SA SNT24206077SA SNT25069024SA SNT25099001SA SNT25099005SA SNT25099003SA SNT25099004SA SNT25099006SA SNT25289533SA SNT25289532SA SNT25139501SA SNT25309501SA SNT25309504SA SNT25119530SA SNT25119003SA SNT25119004SA SNT25119001SA SNT25119002SA SNT25269502SA SNT25269504SA SNT25269513SA SNT25269512SA SNT25269511SA SNT25269510SA SNT25269516SA SNT25269518SA SNT25249589SA SNT25249582SA SNT25249594SA SNT25249587SA SNT25249593SA SNT25249598SA SNT25129019SA SNT25129018SA SNT25129017SA SNT25129016SA SNT25129626SA SNT25259004SA SNT25249041SA SNT25259012SA SNT25259014SA SNT25259003SA SNT25249042SA SNT25259010SA SNT25249030SA SNT25249044SA SNT25259013SA SNT25259001SA SNT25259006SA SNT25259016SA SNT25259005SA SNT25079557SA SNT25049598SA SNT25049571SA SNT25049554SA SNT25049516SA SNT25049541SA SNT25049533SA SNT25049626SA SNT25049539SA SNT25179586SA SNT25179607SA SNT25179600SA SNT25179599SA SNT25179585SA SNT25179582SA SNT25179609SA SNT25179590SA SNT25179602SA SNT25179603SA SNT25179604SA SNT25179608SA SNT25179605SA SNT25179606SA SNT25179618SA SNT25179595SA SNT25059521SA SNT25059524SA SNT25059523SA SNT25059520SA SNT25059522SA SNT25059526SA SNT25059518SA SNT25059519SA SNT25059525SA SNT25049642SA SNT25059517SA SNT25059514SA SNT25059515SA SNT25059512SA SNT25059510SA SNT25059528SA SNT25059513SA SNT25059508SA SNT25059516SA SNT25079637SA SNT25079653SA SNT25079638SA SNT25079655SA SNT25079634SA SNT25079640SA SNT25079635SA SNT25079625SA SNT25079647SA SNT25079627SA SNT25209003SA SNT25209002SA SNT25209004SA SNT25259551SA SNT25259578SA SNT25259545SA SNT25259583SA SNT25259592SA SNT25149595SA SNT25069501SA SNT25159501SA SNT25159508SA SNT25159504SA SNT25159502SA SNT25159506SA SNT25159509SA SNT25159511SA SNT25159505SA SNT25159507SA SNT25149574SA SNT25159516SA SNT25159510SA SNT25159515SA SNT25159518SA SNT25159519SA SNT25159514SA SNT25159520SA SNT25159512SA SNT25069509SA SNT25199518SA SNT25199520SA SNT25199523SA SNT25229003SA SNT25209001SA SNT24499326SA SNT24499324SA SNT24499327SA SNT25229002SA SNT25229007SA SNT25229008SA SNT25229009SA SNT25229014SA SNT25229005SA SNT25229006SA SNT25229012SA SNT25229011SA SNT25229001SA SNT25269006SA SNT25079707SA SNT25089008SA SNT25089006SA SNT25089005SA SNT25089007SA SNT25179569SA SNT25179568SA SNT25079531SA SNT25079542SA SNT25079562SA SNT25079560SA SNT25079552SA SNT25119529SA SNT25119532SA SNT25119533SA SNT25119531SA SNT25119528SA SNT25119527SA SNT25129573SA SNT25129582SA SNT25129570SA SNT25139538SA SNT25139537SA SNT25139535SA SNT25139539SA SNT24206004SA SNT24206057SA SNT25139569SA SNT25179601SA SNT25179580SA SNT25179593SA SNT25179588SA SNT25179597SA SNT25179596SA SNT25249639SA SNT25249644SA SNT25249647SA SNT25249643SA SNT25249637SA SNT25249638SA SNT25249635SA SNT25249640SA SNT25249585SA SNT25249553SA SNT25249648SA SNT25249649SA SNT25249651SA SNT25249634SA SNT25249650SA SNT25249646SA SNT25179010SA SNT25179008SA SNT25179013SA SNT25179007SA SNT25189501SA SNT25139001SA SNT25139004SA SNT24499330SA SNT24499323SA SNT24206041SA SNT24206022SA SNT24206047SA SNT24206015SA SNT25129574SA SNT25129583SA SNT25129585SA SNT25129602SA SNT25129589SA SNT25129588SA SNT25129579SA SNT25129593SA SNT25129597SA SNT25129594SA SNT25129591SA SNT25129577SA SNT25129572SA SNT25129592SA SNT25129011SA SNT25089002SA SNT25089001SA SNT25089003SA SNT25089690SA SNT25129502SA SNT25129509SA SNT25129511SA SNT25129512SA SNT25129510SA SNT25129514SA SNT25149511SA SNT25089004SA SNT25179572SA SNT25179014SA SNT25179009SA SNT25179012SA SNT25179011SA SNT25199508SA SNT25199507SA SNT25209505SA SNT25209512SA SNT25209510SA SNT25209501SA SNT25209514SA SNT25209516SA SNT25209515SA SNT25209513SA SNT25229537SA SNT25229536SA SNT25289529SA SNT25119534SA SNT25129530SA SNT25149530SA SNT25149515SA SNT25149560SA SNT25149559SA SNT25149518SA SNT25149568SA SNT25149555SA SNT25149567SA SNT25149554SA SNT25149569SA SNT25149572SA SNT25149552SA SNT25149566SA SNT25149571SA SNT25149575SA SNT25149577SA SNT25149576SA SNT25149564SA SNT25149556SA SNT25149542SA SNT25149540SA SNT25149581SA SNT25149578SA SNT25149565SA SNT25149584SA SNT25149585SA SNT25149587SA SNT25149588SA SNT25149563SA SNT25149535SA SNT25149589SA SNT25149590SA SNT25149580SA SNT25149579SA SNT25149562SA SNT25149594SA SNT25149591SA SNT25149593SA SNT25149592SA SNT25149553SA SNT25149586SA SNT25149573SA SNT25149550SA SNT25149532SA SNT25149526SA SNT25149533SA SNT25149549SA SNT25149523SA SNT25149603SA SNT25149582SA SNT25149583SA SNT25179567SA SNT25179571SA SNT25209518SA SNT25209520SA SNT25209522SA SNT25209521SA SNT25209523SA SNT25209524SA SNT25239507SA SNT24499600SA SNT25239512SA SNT25239513SA SNT25239514SA SNT25239516SA SNT25239515SA SNT25239509SA SNT25239517SA SNT25239518SA SNT25239521SA SNT25239523SA SNT25239522SA SNT25239519SA SNT25239524SA SNT25239510SA SNT25239525SA SNT25239505SA SNT24499599SA SNT25239508SA SNT25239511SA SNT25239502SA SNT25239503SA SNT25239504SA SNT25239506SA SNT25239501SA SNT25239520SA SNT25239526SA SNT25239527SA SNT25239532SA SNT25239530SA SNT25239529SA SNT25159662SA SNT25159664SA SNT25159673SA SNT25159677SA SNT25159686SA SNT25189559SA SNT25079630SA SNT24529631SA SNT25019503SA SNT25159581SA SNT25159584SA SNT25069503SA SNT24459517SA SNT24459620SA SNT25039649SA SNT25309503SA SNT25129555SA SNT25129558SA SNT25099714SA SNT25099697SA SNT25099703SA SNT25099734SA SNT25149596SA SNT25149601SA SNT25149600SA SNT25149599SA SNT25149602SA SNT25149597SA SNT25149598SA SNT25269603SA SNT25269602SA SNT25069525SA SNT25069533SA SNT25069534SA SNT25069535SA SNT25069526SA SNT25069522SA SNT25069523SA SNT25069524SA SNT25069521SA SNT25069529SA SNT25069530SA SNT25069532SA SNT25069531SA SNT25069515SA SNT25079013SA SNT25089013SA SNT25089010SA SNT25089016SA SNT25089009SA SNT25089011SA SNT25089014SA SNT25089015SA SNT25149002SA SNT25149001SA SNT25319529SA SNT25059579SA SNT25059581SA SNT25079512SA SNT25079513SA SNT25079518SA SNT25079511SA SNT25079503SA SNT25079519SA SNT25079510SA SNT25079528SA SNT25079509SA SNT25079507SA SNT25079554SA SNT25079556SA SNT25079705SA SNT25079721SA SNT25079720SA SNT25079718SA SNT25079722SA SNT25079712SA SNT25089640SA SNT25089654SA SNT25089653SA SNT25089644SA SNT25089655SA SNT25089661SA SNT25089660SA SNT25089659SA SNT25089652SA SNT25089668SA SNT25089667SA SNT25089643SA SNT25089670SA SNT25089672SA SNT25089669SA SNT25089677SA SNT25089674SA SNT25089666SA SNT25089675SA SNT25089676SA SNT25089664SA SNT25089673SA SNT25089646SA SNT25089682SA SNT25089685SA SNT25089684SA SNT25139512SA SNT25139510SA SNT25139509SA SNT25139519SA SNT25139516SA SNT25139515SA SNT25139517SA SNT25129612SA SNT25139518SA SNT25139511SA SNT25139520SA SNT25139503SA SNT25139525SA SNT25139523SA SNT25139528SA SNT25139521SA SNT25139529SA SNT25139527SA SNT25139526SA SNT25139532SA SNT25139524SA SNT25139530SA SNT25139531SA SNT25139513SA SNT25139508SA SNT25129624SA SNT25139522SA SNT25139514SA SNT25139504SA SNT25139533SA SNT25139534SA SNT25129613SA SNT25139536SA SNT25159646SA SNT25159658SA SNT25159648SA SNT25159650SA SNT25159654SA SNT25159647SA SNT25159652SA SNT25159655SA SNT25179510SA SNT25179512SA SNT25179513SA SNT25179514SA SNT25179501SA SNT25179511SA SNT25159712SA SNT25159711SA SNT25159714SA SNT25179503SA SNT25179509SA SNT25179506SA SNT25179532SA SNT25179505SA SNT25079632SA SNT25079713SA SNT25079714SA SNT25079733SA SNT25089642SA SNT25089647SA SNT25089662SA SNT25089663SA SNT25089679SA SNT25159641SA SNT25159649SA SNT25159651SA SNT25159653SA SNT25159656SA SNT25159657SA SNT25159660SA SNT25159731SA SNT25179502SA SNT25179504SA SNT25179507SA SNT25179508SA SNT24509569SA SNT25059001SA SNT25169501SA SNT25169502SA SNT25149517SA SNT24489302SA SNT24489310SA SNT25049030SA SNT25049028SA SNT25049029SA SNT25049027SA SNT25049577SA SNT25039597SA SNT25199563SA SNT25199565SA SNT25199570SA SNT25199573SA SNT25199566SA SNT25199574SA SNT25199569SA SNT25199572SA SNT25199571SA SNT25219510SA SNT25219506SA SNT25219514SA SNT25219508SA SNT25219511SA SNT25219512SA SNT25219518SA SNT25219519SA SNT25219515SA SNT25219525SA SNT25219522SA SNT25219523SA SNT25239018SA SNT25239016SA SNT25299001SA SNT25299002SA SNT25109012SA SNT25179566SA SNT25179564SA SNT25179563SA SNT25179565SA SNT24469512SA SNT24429998SA SNT24439621SA SNT24429995SA SNT25119512SA SNT25119505SA SNT25119507SA SNT25119509SA SNT25119513SA SNT25119514SA SNT25119515SA SNT25119519SA SNT25119508SA SNT25119522SA SNT25119525SA SNT25119524SA SNT25119521SA SNT25119520SA SNT25119506SA SNT25119503SA SNT25119502SA SNT25119504SA SNT25119510SA SNT25119511SA SNT25119523SA SNT25119526SA SNT25149005SA SNT25149522SA SNT25149003SA SNT25149006SA SNT25149004SA SNT25199517SA SNT25199515SA SNT25199510SA SNT2... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 19, 2025
- Recall initiation date
- Sep 26, 2025
- Center classification date
- Nov 7, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.