Hazard

Inaccurate Reading recalls

100 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 100
Critical: 2
Severe: 2
Most recent: 2021-05-26

Of the 100 inaccurate reading recalls we have scored against our rubric, 2 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (2%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate reading recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 100

HighFDA (Devices)·Z-1604-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1614-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings
Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1601-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose l
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1607-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate glucose readings.
Product
Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 20763000243320 GS3 5PK 9L OUS1/ GTIN: 20763000318844 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1616-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units worldwide because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose le
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1615-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate glucose readings.
Product
Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1602-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea can cause inaccurate, elevated glucose readings.
Product
Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1610-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate elevated glucose readings when used with hydroxyurea.
Product
Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1603-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1617-2021·2021-05-26
Medtronic Enlite Glucose Sensor Recalled for Inaccurate Readings
Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea may cause inaccurate elevated readings.
Product
Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabet
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1612-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate high glucose readings.
Product
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing sy
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1618-2021·2021-05-26
Medtronic Enlite Glucose Sensor Recall for Hydroxyurea Interaction
Medtronic is recalling 207 units of Enlite Glucose Sensors because use with hydroxyurea can cause inaccurate elevated glucose readings.
Product
Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabet
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1599-2021·2021-05-26
Medtronic Enlite Glucose Sensor Recall Due to Hydroxyurea Interference
Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea may cause inaccurate elevated readings.
Product
Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Med
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1608-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate glucose readings when used with hydroxyurea.
Product
Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor gluc
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1600-2021·2021-05-26
Medtronic Enlite Glucose Sensor Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea can cause inaccurate elevated readings.
Product
Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 Product Usage: intended for use with Medtronic Diabetes (Med
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1611-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GS3 5PK 1L AUS/ GTIN: 20763000414362 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1605-2021·2021-05-26
Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea can cause inaccurate elevated glucose readings.
Product
Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1609-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate high glucose readings.
Product
Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000243368 GS3 5PK 9L OUS3/ GTIN: 20763000318882 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1613-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate glucose readings.
Product
Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucos
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1606-2021·2021-05-26
Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
Medtronic is recalling Guardian Sensor 3 kits because use with the drug hydroxyurea may cause inaccurate, elevated glucose readings.
Product
Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monit
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1326-2021·2021-04-07
Philips SureSigns Patient Monitors Recalled for Pediatric Heart Rate Accuracy Issues
Philips is recalling SureSigns VM4, VM6, and VM8 patient monitors in China because they fail to meet Chinese standards for heart rate accuracy in pediatric mode.
Product
Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1984-2020·2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA recalls 468 Dover Foley catheters with temperature sensors that failed accuracy tests. Incorrect readings could lead to misdiagnosis.
Product
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1561-2020·2020-04-01
Dexcom G5 and G4 PLATINUM Systems Recalled for Hydroxyurea Interference
Dexcom Inc is recalling G5 and G4 PLATINUM Continuous Glucose Monitoring Systems because hydroxyurea use may cause falsely elevated glucose readings.
Product
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1560-2020·2020-04-01
Dexcom G4 Platinum Recall Due to Hydroxyurea Interference
Dexcom Inc is recalling G4 PLATINUM systems because hydroxyurea use may cause falsely elevated glucose readings.
Product
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1562-2020·2020-04-01
Dexcom G6 Continuous Glucose Monitoring System Recalled for Hydroxyurea Interference
Dexcom Inc is recalling G6 Continuous Glucose Monitoring Systems because the anti-neoplastic drug hydroxyurea may cause falsely elevated glucose readings.
Product
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
Category
Medical Device
Distribution
0 states