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

9276–9300 of 39932

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
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-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-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-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-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-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
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
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-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
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
SevereFDA (Devices)·Z-2379-2023·2023-08-23
Dialysis Catheters Recalled Due to Excessive Lubricant Causing Obstruction
Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant coating the catheter tip, potentially causing dangerous blockages that delay treatment or lead to serious complications.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2378-2023·2023-08-23
Dialysis catheter recall: excessive lubricant causes center lumen obstruction
A dialysis catheter product is being recalled due to excessive lubricant coating in the center lumen, which may cause full or partial obstruction. The blockage could delay treatment and increase risk of blood clots and hemolysis.
Product
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2386-2023·2023-08-23
MAHURKAR dialysis catheters recalled for center lumen occlusion risk
Covidien LP recalls MAHURKAR dialysis catheters due to excessive silicone lubricant on the catheter tip, which can obstruct the center lumen. This may delay treatment and cause serious blood complications including embolism and thrombosis.
Product
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2368-2023·2023-08-23
Dialysis Catheter Recalled Due to Excessive Lubricant Causing Center Lumen Obstruction
Covidien is recalling MAHURKAR dialysis catheters due to excessive silicone-based lubricant coating the center lumen tip, which may cause partial or complete obstruction, delaying treatment or causing thrombosis.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2381-2023·2023-08-23
MAHURKAR Dialysis Catheter Recalled for Excessive Lubricant Causing Occlusion
The MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can obstruct the center lumen, potentially delaying critical dialysis treatment.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2372-2023·2023-08-23
FDA Recalls MAHURKAR Dialysis Catheters Over Obstruction Defect Risk
Covidien's MAHURKAR dialysis catheters are recalled due to excessive lubricant on the catheter tip causing partial or complete obstruction. This risks delaying treatment and may cause blood clots, hemolysis, or embolism.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2406-2023·2023-08-23
Alcon Constellation Procedure Pak recalled due to plastic debris risk
Alcon is recalling the Constellation Procedure Pak due to reports of patient injury from plastic debris. The debris can result from over-tightening the device with the included plastic wrench.
Product
Constellation Procedure Pak
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2389-2023·2023-08-23
MAHURKAR Dialysis Catheter Recalled for Center Lumen Obstruction Risk
Covidien LP recalled 15,209 MAHURKAR dialysis catheters due to excessive lubricant in the center lumen, which may cause catheter occlusion, reduce blood flow, or lead to hemolysis and blood clots.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2375-2023·2023-08-23
Dialysis catheter recalled due to excessive lubricant causing obstruction
Covidien's MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can block the center lumen, preventing or reducing blood flow during dialysis. This Class I recall affects 271 units and carries risk of treatment delays, hemolysis, and blood clots.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2373-2023·2023-08-23
Dialysis Catheter Recall Due to Potential Lumen Occlusion
Covidien LP is recalling MAHURKAR dialysis catheters due to excess silicone lubricant that can block the central lumen, potentially delaying treatment or causing serious complications.
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2408-2023·2023-08-23
Infinity FMS Pak surgical device recalled for plastic debris hazard
Alcon is recalling the Infinity FMS Pak surgical device after reports of patient injuries during procedures caused by plastic debris from over-tightening the included wrench. The recall affects 51,054 units distributed worldwide.
Product
Infinity FMS Pak
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2410-2023·2023-08-23
Phaco Standalone Tips Recalled Due to Plastic Debris Risk
Alcon is recalling 444,372 units of Phaco Standalone Tips worldwide because the plastic wrench included with the product can generate plastic debris when over-tightened, potentially injuring patients.
Product
Phaco Standalone Tips
Category
Medical Device
Distribution
Distributed nationwide

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9276–9300 of 39932