Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

9301–9325 of 40095

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, 30010341
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 (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
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 (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 (Devices)·Z-2447-2023·2023-08-30
Air/Water Valve Used with Olympus Endoscopes May Malfunction
Olympus air/water valves used with ultrasonic endoscopes may fail during automated reprocessing, potentially allowing body fluids to backflow into the air channel. Approximately 29,590 units nationwide are affected.
Product
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2441-2023·2023-08-30
EMBLEM S-ICD Pulse Generator May Lose Heart Sensing for 24 Hours
Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.
Product
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Category
Medical Device
Distribution
0 states
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-2462-2023·2023-08-30
Medicrea IMPIX MANTA+ Cervical Fusion Devices Recalled for Packaging Defect
Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices due to potential packaging non-conformity with pinholes in inner or outer pouches. No illnesses or injuries reported.
Product
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2456-2023·2023-08-30
Intervertebral fusion device recalled for packaging non-conformity issue
Medicrea International is recalling 4,489 IMPIX MANTA intervertebral fusion devices due to potential pinholes in product packaging that could compromise device sterility.
Product
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar
Category
Medical Device
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 (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-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-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 (Devices)·Z-2459-2023·2023-08-30
Medicrea GRANVIA-C Cervical Fusion Device Recalled for Packaging Defects
Medicrea International is recalling GRANVIA-C cervical intervertebral fusion devices due to a packaging non-conformity issue presenting as pinholes in inner or outer pouches, which could compromise sterility.
Product
GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m
Category
Medical Device
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 (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 (Devices)·Z-2446-2023·2023-08-30
Randox Liquid Urine Control Level 2 Recalled for Analytical Accuracy Issues
Randox Liquid Urine Control Level 2 (Lot 1209UC) is recalled for incorrect hCG and cortisol values and a transcription error in instructions. The defects may delay patient test reporting.
Product
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific
Category
Medical Device
Distribution
Distributed nationwide
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-2445-2023·2023-08-30
Dolomite Gloss Rollator Structural Failure Recall: Seat Collapse Risk
Dolomite Gloss Rollator models may experience seat failure and structural collapse due to broken eyelets and crossbar, potentially causing user injury. About 586 units nationwide are affected.
Product
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
Category
Medical Device
Distribution
Distributed nationwide
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) B247C07062
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2453-2023·2023-08-30
Medicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect
Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed nationwide due to a potential packaging defect with pinholes in the device pouch.
Product
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2461-2023·2023-08-30
Cervical intervertebral fusion devices recalled for packaging defect
Medicrea International is recalling IMPIX S cervical intervertebral fusion devices due to a potential packaging defect involving pinholes in the inner or outer pouch. No injuries have been reported.
Product
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2457-2023·2023-08-30
Medicrea Recalls IMPIX TLIF Fusion Devices for Packaging Defects
Medicrea International is recalling IMPIX TLIF intervertebral fusion devices due to potential packaging defects. The devices may have pinholes in the inner or outer packaging pouches.
Product
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2383-2023·2023-08-23
FDA Recalls Dialysis Catheters for Center Lumen Obstruction Risk
Covidien is recalling MAHURKAR dialysis catheters because the center lumen may be blocked by excess silicone lubricant. This could delay treatment and cause blood clots, hemolysis, or embolism.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP
Category
Medical Device
Distribution
Distributed nationwide

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9301–9325 of 40095