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

9351–9375 of 13717

HighFDA (Devices)·Z-1670-2023·2023-06-07
Smith & Nephew ENGAGE Cementless Knee System Recalled Over Revision Rate Concerns
Smith & Nephew has recalled 1,994 units of its ENGAGE Cementless Partial Knee System because recent data shows higher-than-expected revision rates compared to similar devices.
Product
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF 1-
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1664-2023·2023-06-07
VITROS Chemistry Calibrator Kit Cannot Calibrate Vancomycin Reagent
Ortho-Clinical Diagnostics is recalling 132 units of VITROS Chemistry Calibrator Kit 11 with defective Assay Data Disk versions due to inability to calibrate vancomycin reagent, delaying laboratory testing.
Product
VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Che
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1618-2023·2023-05-31
Pediatric Ventricular Assist Device Blood Pumps Recalled for Potential Membrane Disruption
BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps due to potential disruption in triple-layer membranes. The 335 affected units were distributed to multiple US states and Canada.
Product
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was r
Category
Medical Device
Distribution
16 states
SevereFDA (Devices)·Z-1594-2023·2023-05-31
COVID-19 At-Home Test Kits Recalled for Bacterial Buffer Contamination
SD Biosensor is recalling 2,712,767 Pilot COVID-19 At-Home Test kits nationwide due to bacterial contamination in the liquid buffer component. Users may notice an odor from affected kits.
Product
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1623-2023·2023-05-31
Philips Incisive CT System Recalled for Potential Image Orientation Error
Philips recalls the Incisive CT whole-body X-Ray imaging system in 22 units due to potential incorrect image orientation that could result in flipped or reversed images, leading to misdiagnosis, incorrect treatment, or unnecessary radiation exposure.
Product
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1619-2023·2023-05-31
Medical Device Spine Pack Light Handles May Separate During Surgical Use
Windstone Medical Packaging recalls Aligned Medical Solutions Spine Pack kits due to light handle covers that may separate during surgery. This could delay procedures and compromise the sterile field, potentially injuring patients.
Product
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1613-2023·2023-05-31
Olympus Single Use Distal Cover for Endoscope Recalled Due to Detachment Risk
Olympus is recalling about 309,278 single-use endoscope covers that may detach during use, risking aspiration, inhalation, obstruction, or burns.
Product
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1614-2023·2023-05-31
Cranial Hand Drill recalled due to rust on chuck components
Integra LifeSciences Corp. is recalling 337 units of the Codman Cranial Hand Drill due to rust contamination on the drill chuck. The rust may cause inflammation, infection, and complications requiring revision surgery.
Product
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1617-2023·2023-05-31
Omnicell IVX Station medical device recalled for dose accuracy failures
OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.
Product
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1625-2023·2023-05-31
Incisive CT Plus imaging system recalled for potential incorrect image orientation
Philips is recalling 5 Incisive CT Plus CT X-ray systems due to potential defects that may display images with flipped or reversed orientation, risking misdiagnosis, incorrect treatment, and unnecessary radiation exposure from repeat scans.
Product
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1626-2023·2023-05-31
Diagnostic Cartridge Assay May Fail to Detect Chlamydia Trachomatis Correctly
Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.
Product
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1629-2023·2023-05-31
Arjo Portable Scale Adaptor Model 700.05725 Recalled for Potential Strap Detachment
Arjohuntleigh Magog, Inc. is recalling certain Arjo Portable Scale Adaptors due to straps with potential to detach. Three units were distributed in Ohio and New York.
Product
Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1631-2023·2023-05-31
Medical Device Calibrator Recall for Salicylate Assay Due to Measurement Bias
Siemens Healthcare is recalling ADVIA Chemistry ToxAmmonia Calibrators due to positive bias in salicylate assay measurements. Affected calibrators were distributed across the US and internationally.
Product
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1622-2023·2023-05-31
Philips CT Scanner May Display Images With Incorrect Orientation
Philips Incisive CT X-ray systems may display medical images in incorrect orientation, potentially leading to misdiagnosis, incorrect treatment, and unnecessary radiation exposure if rescans are needed.
Product
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1624-2023·2023-05-31
Incisive CT Power X-Ray System may display flipped or reversed images
The Incisive CT Power X-Ray System (Model 728148) may display computed tomography images with incorrect orientation—flipped or reversed—potentially leading to misdiagnosis, incorrect treatment, or additional radiation exposure from rescanning.
Product
Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1620-2023·2023-05-31
Aligned Medical Solutions hand pack light covers may separate during use
Windstone Medical Packaging recalls the Aligned Medical Solutions Minor Hand Pack because light handle covers may detach during procedures. This could delay surgery and compromise the sterile field, risking patient injury.
Product
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1628-2023·2023-05-31
VITROS Chemistry HbA1c Reagent Kit recalled due to inaccurate test results
Ortho-Clinical Diagnostics is recalling VITROS Chemistry HbA1c Reagent Kits due to potential for false-positive and false-negative results, which may lead to misdiagnosis.
Product
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1621-2023·2023-05-31
Aligned Medical Solutions Hand Pack covers may detach during surgical use
Windstone Medical Packaging is recalling Aligned Medical Solutions Hand Pack kits because light handle covers may detach during surgical procedures, potentially compromising the sterile field.
Product
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1615-2023·2023-05-31
ViziShot 2 Aspiration Needle recalled for manufacturing angle defect
ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.
Product
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1481-2023·2023-05-31
LUMINOS Lotus Max fluoroscopic system recalled for sporadic measurement errors
LUMINOS Lotus Max fluoroscopic systems may sporadically display incorrect radiation dose measurements. The error only occurs with secondary X-ray tubes and does not affect diagnosis or workflow.
Product
LUMINOS Lotus Max (VF11)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1480-2023·2023-05-31
Fluoroscopic Imaging System May Display Incorrect Radiation Dose Measurements
Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.
Product
Luminos dRF Max (VE10, VF10, VF11)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1616-2023·2023-05-31
Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance
Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.
Product
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1479-2023·2023-05-31
Fluoroscopic imaging system may display incorrect radiation dose readings
Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.
Product
Luminos Agile Max (VE10, VF10, VF11)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1632-2023·2023-05-31
Siemens Atellica CH Toxicology Calibrator Reassignment Due to Positive Bias
Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrators due to a positive bias. The affected calibrators were distributed in the US and internationally across multiple countries.
Product
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1447-2023·2023-05-24
Draeger VentStar Anesthesia Breathing Circuit Connections May Detach
Draeger Medical recalls VentStar Anesthesia (N) 180 breathing circuits. Glued connections can loosen or detach during ventilation, potentially creating a critical disconnection risk.
Product
VentStar Anesthesia (N) 180, MP00333
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

9351–9375 of 13717