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

10126–10150 of 40095

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-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
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-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-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-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-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
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-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-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-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-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-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
SevereFDA (Devices)·Z-1460-2023·2023-05-24
Anesthesia circuit kit may detach during ventilation due to loose glued connections
Draeger Medical is recalling its Anesthesia Circuit Kit Coax HEPA (720 units) because glued connections can become loose during ventilation, potentially causing partial or complete detachment that could interrupt oxygen delivery during surgery.
Product
Anesthesia Circuit Kit Coax HEPA, MP17102
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1455-2023·2023-05-24
Ventstar Coax 180 Ventilator Breathing Circuit Connections May Detach
Draeger Medical is recalling 18,160 Ventstar Coax 180 ventilators because glued breathing circuit connections can become loose and detach during use, potentially disrupting oxygen delivery.
Product
Ventstar Coax 180, MP03374
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1456-2023·2023-05-24
Breathing circuit component connections may become loose during ventilation
Draeger Medical recalls ID Coax 180 breathing circuit components due to glued connections that can become loose or detach during ventilation.
Product
ID Coax 180, MP03375
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1450-2023·2023-05-24
Draeger VentStar Breathing Circuit Connections May Loosen During Use
Draeger Medical is recalling the VentStar Bag Set because glued connections on the breathing circuit can become loose or detach during ventilation, potentially compromising respiratory support.
Product
VentStar Bag Set (N) 110, MP00383
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1565-2023·2023-05-24
Replacement Battery in Plum 360 Infusion System Recalled for Capacity Loss
ICU Medical Inc is recalling 28,656 replacement batteries used in the Plum 360 Infusion System due to a manufacturing defect that causes premature capacity loss and decreased runtime. Affected units are distributed worldwide.
Product
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1448-2023·2023-05-24
VentStar Basic Ventilator Recall: Risk of Breathing Circuit Detachment
Draeger Medical is recalling 1,725 VentStar Basic ventilators because glued breathing circuit connections can become loose and detach before or during ventilation. This may disrupt patient breathing support.
Product
VentStar Basic (N) 180, MP00353
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1458-2023·2023-05-24
Anesthesia Set Coax 180 Breathing Circuit Connection Risk
Draeger Medical is recalling the Anesthesia Set Coax 180 because glued breathing circuit connections can become loose during ventilation, causing partial or complete detachment.
Product
Anesthesia Set Coax 180, MP03384
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1590-2023·2023-05-24
Impella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate
Abiomed is recalling 610 units of the Impella 5.5 with SmartAssist catheter due to a heightened complaint rate for purge leaks. This intravascular pump provides circulatory support during critical care.
Product
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1566-2023·2023-05-24
Plum A+ & A+3 Infusion System Batteries Recalled Due to Manufacturing Defect
ICU Medical Inc is recalling replacement batteries used in Plum A+ and A+3 infusion pump systems. A manufacturing defect may cause batteries to lose capacity earlier than expected.
Product
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1441-2023·2023-05-24
VentStar Basic ventilator breathing circuit connections may detach
Draeger Medical is recalling 200 units of the VentStar Basic ventilator due to glued breathing circuit connections that can loosen or detach before or during ventilation.
Product
VentStar Basic (P)250, MP00352
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1457-2023·2023-05-24
Ventstar Coax 230 breathing circuit connections can detach during ventilation
The FDA is recalling Draeger Medical's Ventstar Coax 230 breathing circuit components due to glued connections that can become loose and detach during ventilation, potentially compromising patient breathing support.
Product
Ventstar Coax 230, MP03376
Category
Medical Device
Distribution
Distributed nationwide

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10126–10150 of 40095