Hazard

Inaccurate Dosing recalls

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

What the numbers show

Total: 25
Critical: 0
Severe: 0
Most recent: 2024-07-17

Of the 25 inaccurate dosing recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inaccurate dosing 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 25

HighFDA (Devices)·Z-2330-2024·2024-07-17
Presource Neurological Surgical Kits Recalled for Syringe Design Defect
Cardinal Health is recalling Presource neurological surgical kits containing defectively designed syringes that may cause inaccurate dosing or device leakage. The recall affects 13,487 kits distributed nationwide.
Product
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2024·2024-07-17
Presource surgical kits recalled for syringe design defect risk
Cardinal Health is recalling 136,753 Presource surgical kits nationwide because included Shenli syringes contain design modifications that could cause inaccurate dosing and device leakage, risking patient harm.
Product
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2024·2024-07-17
Cardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect
Cardinal Health is recalling Presource Cardiac Catheterization Kits because the included syringes may have design defects that could cause inaccurate dosing or leakage, creating a risk of patient harm.
Product
Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number SAN69CCKRB; 2) Cardiac Catheterization Kit, Catalog Number SAN73CCV10; 3) Cardiac Catheterization Kit, Catalog Number SAN73CCV11; 4) Cardiac Catheterization Kit, Catalog Number SAN73CCV1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1938-2024·2024-06-12
Medline Luer Slip Syringes Recalled for Inaccurate Volume Delivery
Medline Industries is recalling over 5 million Luer Slip disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity range. This poses a risk to patient health.
Product
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0718-2021·2020-12-30
B Braun APEX Compounding System Control Panel Module Recalled
B Braun Medical is recalling 85 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.
Product
APEX Compounding System Control Panel Module, REF: 601237, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0717-2021·2020-12-30
B Braun APEX Compounding System Control Panel Module Recalled for Accuracy Issues
B Braun Medical is recalling 248 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially resulting in inaccurate drug compounding.
Product
APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2021·2020-12-30
B Braun APEX Compounding System Control Panel Module Recalled
B Braun Medical is recalling 16 APEX Compounding System Control Panel Modules because they may fail to detect air bubbles, potentially compromising drug accuracy.
Product
APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1918-2020·2020-05-13
ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 25 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
Product
REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1553-2020·2020-04-01
Insulet Omnipod DASH PDM Recalled for Inaccurate Bolus Suggestions
Insulet is recalling Omnipod DASH Personal Diabetes Manager devices because they may suggest inaccurate bolus amounts, potentially leading to hypoglycemia or hyperglycemia.
Product
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0050-2020·2019-10-16
Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes
Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 3 mL dispensers, risking inaccurate dosing.
Product
EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent adminis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2261-2016·2016-08-03
Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling container fill and transfer sets because they may not meet designed accuracy specifications when dispensing into bags.
Product
Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-2260-2016·2016-08-03
Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling container fill and transfer sets because they cannot meet designed accuracy specifications when dispensing into bags.
Product
Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-2257-2016·2016-08-03
Metrix AUTOCOMP6 XPS High Speed Compounder Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling 16 AUTOCOMP6 XPS High Speed Compounders because they cannot meet designed accuracy specifications when dispensing into bags.
Product
AUTOCOMP6 XPS High Speed Compounder REF 58810
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-2258-2016·2016-08-03
Metrix AUTOCOMP6 XP High Speed Compounder Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling 93 AUTOCOMP6 XP High Speed Compounders because they cannot meet designed accuracy specifications when dispensing into bags.
Product
AUTOCOMP6 XP High Speed Compounder REF 58810
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-2263-2016·2016-08-03
Metrix Dual Chamber Container Recall Due to Dispensing Accuracy Issues
The Metrix Company is recalling Dual Chamber Containers because the associated auto-compounding device cannot meet accuracy specifications when dispensing into the bags.
Product
Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 mL
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-2259-2016·2016-08-03
Metrix AUTOCOMP6 High Speed Compounder Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling 323 AUTOCOMP6 High Speed Compounders because the devices cannot meet designed accuracy specifications when dispensing into bags.
Product
AUTOCOMP6 High Speed Compounder
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-2262-2016·2016-08-03
Metrix Dual Chamber Container Fill and Transfer Sets Recalled for Accuracy Issues
The Metrix Company is recalling Dual Chamber Container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications for dispensing volume.
Product
Dual Chamber Container fill and transfer sets, 250 mL / 1250 mL or 500 mL / 2500 mL
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-2264-2016·2016-08-03
Metrix Container Fill and Transfer Sets Recalled for Dispensing Accuracy Issues
The Metrix Company is recalling 250 mL and 500 mL container fill and transfer sets because the associated auto compounding device cannot meet designed accuracy specifications when dispensing into bags.
Product
Container fill and transfer sets, 250 mL and 500 mL, . .
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1368-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding Systems Due to Volume Accuracy Issues
ICU Medical is recalling 47 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.
Product
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues
ICU Medical is recalling 3 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.
Product
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues
ICU Medical is recalling 49 units of the Diana Automated Compounding System because it may not meet accuracy specifications when mixing volumes under 5ml.
Product
Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1367-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues
ICU Medical is recalling 4 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.
Product
Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1364-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues
ICU Medical is recalling 36 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.
Product
Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1365-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues
ICU Medical is recalling 57 Diana Automated Compounding Systems because they may not accurately mix volumes under 5ml.
Product
Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2015·2015-04-08
Roche Recalls Accu-Chek Connect App Due to Inaccurate Bolus Advice
Roche Diabetes Care is recalling the Accu-Chek Connect app because a screen orientation change may cause it to provide inaccurate bolus advice to users.
Product
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Category
Medical Device
Distribution
0 states