NOVAPLUSRecalls & reported problems across all models
Cardinal Health 200, LLC · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one NOVAPLUS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 75
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 7 models of NOVAPLUS by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 75 adverse event reports in the FDA's MAUDE database, received between Oct 2, 2019 and Mar 25, 2026 — classified as 1 injury, 74 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (69 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
NOVAPLUS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 16, 2023Open, Classified
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
Z-2147-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported NOVAPLUS problems
Device problems
- Burst Container or Vessel69
- Break2
- Fluid/Blood Leak2
- Leak/Splash1
- Material Frayed1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions67
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Discomfort2
- Erythema2
- Insufficient Information1
- Skin Burning Sensation1
- Skin Inflammation/ Irritation1
- Tissue Damage1
NOVAPLUS models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NOVAPLUS V11460-010PACK, HOT OR COLD, DISPOSABLE1 recall16 reports
- NOVAPLUS V11460-010Infant heel warmer (chemical heat pack)38 reports
- NOVAPLUS V11450-040BPACK, HOT OR COLD, DISPOSABLE11 reports
- NOVAPLUS V11443-012BPACK, HOT OR COLD, DISPOSABLE7 reports
- NOVAPLUS V11450-040BPACK, HOT OR COLD, DISPOSABLE1 report
- NOVAPLUS V11440-512PACK, HOT OR COLD, DISPOSABLE1 report
- NOVAPLUS V11500-010PACK, HOT OR COLD, DISPOSABLE1 report
Recent NOVAPLUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026
INSTANT INFANT HEEL WARMER PACKET - WENT COLD RATHER THAN WARM WHEN ACTIVATED PER INSTRUCTIONS.
Patient problems: Insufficient Information
MAUDE report 24689201 ↗MalfunctionAug 19, 2025Break
WAS ACTIVATING A HOT PACK (HOT PACK COMPRESS CHAUDE 4.5 X 9 IN) FOR A PATIENT TO USE WHEN THE TOP COMPLETELY BROKE OPEN AND THE INTERNAL CONTENTS WERE EXPELLED APPROXIMATELY 8 FEET IN FRONT OF NURSE, TOWARDS THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22838341 ↗MalfunctionJun 20, 2024
REGISTERED NURSE (RN) ACTIVATED THE HEEL WARMER AS USUAL AND PLACED IT ON INFANT¿S HEEL. NURSE BEGAN ASSESSMENT AND MID ASSESSMENT (~2 MINUTES), THE HEEL WARMER POPPED/EXPLODED AND THE CONTENTS SPLATTED AGAINST INSIDE OF ISOLETTE- ON BLANKETS, WALL OF ISOLETTE AND OUT OF PORTHOLE DOOR ONTO FLOOR. SEAM POPPED OPEN, CONTENTS OF PACKAGE WENT ON INFANT¿S BILATERAL LOWER LEGS, BELOW THE KNEES, AND BEDDING CHANGED. HEEL WARMER PROMPTLY REMOVED AND INFANT CLEANED OF CONTENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19574436 ↗MalfunctionApr 12, 2024
REPORTED BY REGISTERED NURSE THAT AS HE SQUEEZED THE "NOVAPLUS HOT PACK INSTANT" TO ACTIVATE IT, THE CONTENTS SQUEEZED OUT THE TOP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095969 ↗MalfunctionJan 24, 2024Burst Container or Vessel; Burst Container or Vessel
CUSTOMER STATED, WE HAVE RECENTLY RECEIVED CONCERNS FROM OUR PHLEBOTOMY TEAM REGARDING RUPTURED HOT PACKS. THEY HAVE CONFIRMED PRODUCT TO BE CARDINAL¿S AND HAVE PROVIDED ONE LOT NUMBER SO FAR. THREE STAFF MEMBERS WERE SPLASHED AND HAD TO WASH OFF THEIR CLOTHES, NO HARM JUST DISCOMFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18576953 ↗MalfunctionJan 24, 2024Burst Container or Vessel; Burst Container or Vessel
CUSTOMER REPORTED, WE HAVE RECENTLY RECEIVED CONCERNS FROM OUR PHLEBOTOMY TEAM REGARDING RUPTURED HOT PACKS. THEY HAVE CONFIRMED PRODUCT TO BE CARDINAL¿S AND HAVE PROVIDED ONE LOT NUMBER SO FAR. THREE STAFF MEMBERS WERE SPLASHED AND HAD TO WASH OFF THEIR CLOTHES, NO HARM JUST DISCOMFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18576949 ↗MalfunctionJan 24, 2024Burst Container or Vessel; Burst Container or Vessel
CUSTOMER STATED, WE HAVE RECENTLY RECEIVED CONCERNS FROM OUR PHLEBOTOMY TEAM REGARDING RUPTURED HOT PACKS. THEY HAVE CONFIRMED PRODUCT TO BE CARDINAL¿S AND HAVE PROVIDED ONE LOT NUMBER SO FAR. THREE STAFF MEMBERS WERE SPLASHED AND HAD TO WASH OFF THEIR CLOTHES, NO HARM JUST DISCOMFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18576947 ↗MalfunctionOct 19, 2023Burst Container or Vessel; Burst Container or Vessel
CUSTOMER REPORTED THE HOT PACK EXPLODED WHILE NURSE WAS PERFORMING TEST ON NEWBORN. THE CONTENTS DID NOT COME INTO CONTACT WITH NEWBORN OR NURSE'S SKIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17965776 ↗MalfunctionAug 18, 2023Burst Container or Vessel; Burst Container or Vessel
CUSTOMER REPORTED THAT THE HOT PACK EXPLODED ON A NURSE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17578396 ↗MalfunctionAug 10, 2023Burst Container or Vessel; Burst Container or Vessel
MEDWATCH REPORT (B)(4) STATED A PHLEBOTOMY TECHNICIAN ATTEMPTED TO ACTIVATE HEEL WARMER TO USE ON A PATIENT WITH DIFFICULT VENOUS ACCESS IN LATE AFTERNOON. TECH SQUEEZED THE PACK TO ACTIVATE, AND THE PACK BURST AND LEAKED ALL OVER THE PATIENT'S BED. TECH STATES THAT THE PATIENT WAS NOT INJURED, AND HE CLEANED UP THE CONTENTS OFF THE BED. TECH WAS NOT AFFECTED BY THE LEAKED PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17497579 ↗MalfunctionAug 8, 2023Burst Container or Vessel; Burst Container or Vessel
CUSTOMER REPORTED THAT THE INFANT HEEL WARMER EXPLODED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17484602 ↗MalfunctionJul 18, 2023Burst Container or Vessel; Burst Container or Vessel
IT HAS BEEN REPORTED THAT A NOVAPLUS HEEL WARMER BURST ON A STAFF MEMBER AT THEIR HOSPITAL. THERE WAS NO INJURY OR ADVERSE EFFECT, AND NO MEDICATION WAS PROVIDED TO STAFF MEMBER DUE TO THE HEEL WARMER BURSTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17346730 ↗MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel
IT HAS BEEN REPORTED THAT WHEN A NURSE ATTEMPTED TO ACTIVATE A HOT PACK USING NORMAL PRESSURE THE PACK CAME APART. THE BROKEN SIDE WAS FACING UPWARDS AND AS IT BROKE IT BURST FORTH ITS CONTENTS SPRAYING ONTO THE NURSE AND ACROSS TWO OCCUPIED BASSINETS. SOME OF THE CONTENTS SPLASHED ONTO THE NURSES HANDS AND ON HER CHEST. THE CONTENTS WERE IMMEDIATELY CLEANED UP WITHOUT ANY INTERACTION. NURSE IS UNAFFECTED BY THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17243373 ↗MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel
IT HAS BEEN REPORTED THAT WHEN A NURSE ATTEMPTED TO ACTIVATE A HOT PACK USING NORMAL PRESSURE THE PACK CAME APART. THE BROKEN SIDE WAS FACING UPWARDS AND AS IT BROKE IT BURST FORTH ITS CONTENTS SPRAYING ONTO THE NURSE AND ACROSS TWO OCCUPIED BASSINETS. THE CONTENTS LANDED ON THE BABY¿S SWADDLE AND WAS IMMEDIATELY CLEANED BY OTHER STAFF. THE INFANT IS DOING FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17239159 ↗MalfunctionJun 30, 2023Burst Container or Vessel; Burst Container or Vessel
IT HAS BEEN REPORTED THAT WHEN A NURSE ATTEMPTED TO ACTIVATE A HOT PACK USING NORMAL PRESSURE THE PACK CAME APART. THE BROKEN SIDE WAS FACING UPWARDS AND AS IT BROKE IT BURST FORTH ITS CONTENTS SPRAYING ONTO THE NURSE AND ACROSS TWO OCCUPIED BASSINETS. THE CONTENTS LANDED ON THE BABY¿S SWADDLE AND WAS IMMEDIATELY CLEANED BY OTHER STAFF. THE INFANT IS DOING FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17239126 ↗
Other Cardinal Health 200, LLC products
- JACKSON-PRATT20 models · 13 reports · 19 recalls
- Monoject35 models · 96 reports · 11 recalls
- CONVERTORS38 models · 40 reports · 11 recalls
- Argyle33 models · 58 reports · 7 recalls
- Salem Sump31 models · 40 reports · 7 recalls
- Dover45 models · 241 reports · 2 recalls
- Kendall31 models · 51 reports · 3 recalls
- Kangaroo35 models · 130 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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