Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11876–11900 of 53044

HighFDA (Devices)·Z-2430-2023·2023-08-30
Infusion pump alarm may fail to sound due to manufacturing defect
ICU Medical recalls approximately 93,135 Plum 360 infusion pumps due to a manufacturing defect that could prevent alarm signals from sounding. The devices were manufactured between July 2020 and December 2021.
Product
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2458-2023·2023-08-30
Medicrea Cervical Fusion Implants Recalled for Packaging Defect
Medicrea International is recalling 963 PASS LP cervical fusion implants due to potential pinholes in the device packaging. The recall affects units distributed nationwide.
Product
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1102-2023·2023-08-30
Lugol's Strong Iodine Solution Recalled Due to Manufacturing Quality Deviations
Ecometics, Inc. is recalling Lugol's Strong Iodine Solution nationwide due to manufacturing quality deviations. Consumers with affected prescription vials should consult their healthcare provider.
Product
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1087-2023·2023-08-30
Rufinamide 200 mg Tablets Recalled for Manufacturing Process Deviation
Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets (Lot RB2023001A) because a batch was released prior to manufacturing approval. The FDA classified this as a Class II recall.
Product
RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2444-2023·2023-08-30
Femoral nail implant recalled for product labeling and packaging mismatch
Smith & Nephew is recalling 32 units of a femoral nail implant due to labeling mismatch. The package contained 40cm implants but was labeled as 36cm, which could result in incorrect surgical implantation.
Product
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-1449-2023·2023-08-30
FDA-Regulated Food and Supplements Recalled for Potential Rodent Warehouse Contamination
Inmar Supply Chain Solutions recalls multiple FDA-regulated food and dietary supplement products purchased from May 2022 onward due to potential rodent exposure in their Texas warehouse.
Product
Multiple FDA-regulated products. Pallets
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2443-2023·2023-08-30
Femur nail surgical implant mislabeled with incorrect product length
Smith & Nephew recalled a femur nail surgical implant because some packages contained a 40cm product instead of the labeled 36cm version. No injuries have been reported.
Product
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2454-2023·2023-08-30
Intervertebral Fusion Device Recalled for Potential Packaging Defect
Medicrea International is recalling 5 units of IMPIX ALIF intervertebral fusion devices due to a potential packaging defect—a pinhole in the inner or outer pouch.
Product
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2451-2023·2023-08-30
ADVIA Chemistry Urinary Protein Reagent Carryover Causing Incorrect Creatinine Results
A reagent carryover issue in Siemens ADVIA Chemistry urinary protein test kits can cause falsely low creatinine test results. The problem occurs when the creatinine test is run after the protein test on the same system.
Product
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2455-2023·2023-08-30
IMPIX DLIF Intervertebral Fusion Device Recalled for Packaging Defect
Medicrea International is recalling IMPIX DLIF intervertebral fusion devices due to potential pinholes in product packaging that could compromise sterility.
Product
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2439-2023·2023-08-30
BioFire Respiratory Panel 2.1 may produce false negative results
BioFire Respiratory Panel 2.1 kits for FILMARRAY systems may return false negative results due to a manufacturing defect. The recall affects 705 kits distributed to healthcare facilities in the U.S. and select international locations.
Product
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Category
Medical Device
Distribution
24 states
HighFDA (Food)·F-1453-2023·2023-08-30
Romaine Lettuce Recall for Potential Deer Feces Contamination
Pearson Foods Corporation is recalling romaine lettuce due to potential contamination with deer feces. The affected product was distributed in Illinois, and consumers should not consume it.
Product
Pearson Foods Lettuce Romaine. 1, 2.5lb bag per case
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2452-2023·2023-08-30
IMPIX 3D spinal implant recalled for packaging pinhole defect
Medicrea International is recalling 248 units of IMPIX 3D intervertebral fusion devices due to pinholes in the product packaging. The recall covers devices distributed nationwide.
Product
IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1100-2023·2023-08-30
Sodium Fluoride Activator Concentrate Recalled for Manufacturing Practice Violations
Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate nationwide due to manufacturing practice deviations. The product was not manufactured under current good manufacturing practices (CGMP).
Product
activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2449-2023·2023-08-30
O-arm O2 Imaging System Ground Cable Installation Defect Recall
Medtronic is recalling O-arm O2 imaging systems due to an incorrectly installed ground cable. The defect affects 28 units distributed across the US and internationally.
Product
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1097-2023·2023-08-30
Yager's Liniment Recalled for Manufacturing Practice Violations
Ecometics recalls Yager's Liniment due to manufacturing practice violations affecting products nationwide.
Product
YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1458-2023·2023-08-30
Doritos Nacho Cheese Tortilla Chips recalled due to undeclared soy and wheat
Frito-Lay is recalling specific batches of Doritos Nacho Cheese Flavored Tortilla Chips because they may contain undeclared soy and wheat, which are major allergens.
Product
Doritos Nacho Cheese Flavored Tortilla Chips Party Size-14 1/2 oz. (411 g) Doritos Nacho Cheese Flavored Tortilla Chips, 1 oz.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2442-2023·2023-08-30
EMBLEM MRI S-ICD Pulse Generator Recall for Rare Sensing Disablement
Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.
Product
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-1101-2023·2023-08-30
FDA Recalls AstrinGyn Surgical Hemostatic Due to Manufacturing Practice Deviations
Ecometics is recalling 92,967 vials of AstrinGyn (Ferric Subsulfate) Aqueous due to manufacturing practice violations. The product was not manufactured under current good manufacturing practices (CGMP).
Product
AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2448-2023·2023-08-30
FDA Recalls Randox Liquid Protein Calibrators for Measurement Accuracy Error
Randox Laboratories recalled 166 units of Liquid Protein Calibrators (IT2691) after restandardization caused Ferritin results to read approximately 10% higher than targeted calibrator values.
Product
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
Category
Medical Device
Distribution
9 states
HighFDA (Drugs)·D-1104-2023·2023-08-30
OTC Drug Products Recalled for Rodent Contamination and Storage Violations
Inmar Supply Chain Solutions is recalling all OTC drug products due to potential rodent exposure in its distribution center and temperature excursions during storage that may have compromised product integrity.
Product
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
Category
Drug
Distribution
0 states
HighFDA (Food)·F-1455-2023·2023-08-30
Lidl Blueberry Bagels Recalled for Undeclared Sesame Allergen
Crispy Bagel Co. is recalling Blueberry Artificially Flavored Bagels sold at Lidl for containing undeclared sesame. Approximately 3,020 units were distributed to stores in Virginia, North Carolina, and Maryland.
Product
Blueberry Artificially Flavored Bagels By Lidl NET WT 20 OZ (1 LB 4 OZ) 567 g UPC: 2099 0305 Packaged in a plastic bag
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2460-2023·2023-08-30
Medicrea IMPIX C+ Cervical Fusion Device Recalled for Packaging Defect
Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.
Product
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1106-2023·2023-08-30
NAD+ Injectable Vials Recalled for Sterility Assurance Deficiency
NAD+ 200mg/ml vials from Tailor Made Compounding are recalled nationwide due to lack of assurance of sterility (Lot#07192307A2, BUD 11/18/2023). Consumers should discontinue use and consult their healthcare provider.
Product
NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2440-2023·2023-08-30
FilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives
BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.
Product
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
Category
Medical Device
Distribution
24 states