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 the agency’s own highest classification or reported deaths or serious injuries, 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

24051–24075 of 40299

SevereFDA (Devices)·Z-1604-2018·2018-05-09
Philips URODiagnost Imaging System Recalled Due to Uncontrolled Table Rotation
Philips Medical Systems is recalling 20 URODiagnost imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.
Product
708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1601-2018·2018-05-09
Southwest Technologies Recalls Hypothermia Mitts, Slippers, and Caps for Misbranding
Southwest Technologies Inc. is recalling hypothermia mitts, slippers, and caps because they are misbranded for chemotherapy use and linked to two frostbite events.
Product
HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1602-2018·2018-05-09
Southwest Technologies Recalls Hypothermia Slippers Due to Misbranding and Frostbite Reports
Southwest Technologies is recalling hypothermia slippers because they are misbranded for chemotherapy use and two frostbite events were reported.
Product
HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c) Elasto-Gel(TM), SL3001 (d) Elasto-Gel(TM), SL3007 (e) Elasto-Gel(TM), SL3008
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1451-2018·2018-05-09
Siemens SOMATOM Spirit CT Scanner Recalled for Incorrect Dose Calculations
Siemens Medical Solutions is recalling SOMATOM Spirit CT scanners because the CARE Dose4D algorithm may calculate incorrect tube current for head scans, potentially leading to unnecessary radiation exposure.
Product
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1592-2018·2018-05-09
Cook Inc. Recalls StoneBreaker Exhaust Lines Due to Sterility Concerns
Cook Inc. is recalling 760 StoneBreaker Exhaust Lines because the interior may not be properly sterilized during reprocessing.
Product
StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1447-2018·2018-05-09
Siemens SOMATOM Perspective CT Scanner Recalled for Dose Calculation Error
Siemens Medical Solutions is recalling 1,301 SOMATOM Perspective CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.
Product
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1546-2018·2018-05-09
Medi-Vac Suction Canister Liners Recalled for Missing Valve
Cardinal Health is recalling 3,600 Medi-Vac Flex Advantage Suction Canister Liners distributed in Massachusetts because they may be missing a one-way valve.
Product
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1445-2018·2018-05-09
Siemens SOMATOM Emotion 6 CT Scanner Recalled for Dose Calculation Error
Siemens is recalling 1,301 SOMATOM Emotion 6 CT scanners because the CARE Dose4D algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.
Product
SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1456-2018·2018-05-09
Siemens SOMATOM Sensation 64 CT Scanner Recalled for Incorrect Dose Calculations
Siemens Medical Solutions is recalling 1,301 SOMATOM Sensation 64 CT scanners because the CARE Dose4D algorithm may calculate incorrect tube current for head scans, potentially leading to unnecessary radiation exposure.
Product
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1540-2018·2018-05-09
Siemens Dimension Vista Calcium Flex Reagent Cartridge Recalled for Low Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Calcium Flex reagent cartridges because they may produce erroneously low results from specific well sets.
Product
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1600-2018·2018-05-09
Southwest Technologies Recalls Misbranded Hypothermia Caps for Cancer Patients
Southwest Technologies is recalling hypothermia caps and other products misbranded for chemotherapy use, following reports of frostbite.
Product
HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elasto-Gel(TM), CAP613 (d) Elasto-Gel(TM), CAP617 (e) Elasto-Gel(TM), CAP619 (f) Elasto-Gel(TM), CAP619LV (g) Elasto-Gel(TM), CAP622
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1450-2018·2018-05-09
Siemens SOMATOM Scope Power CT Scanner Recall for Incorrect Dose Calculations
Siemens Medical Solutions is recalling SOMATOM Scope Power CT scanners due to potential incorrect radiation dose calculations for head scans.
Product
SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1587-2018·2018-05-09
Siemens Atellica Solution and Sample Handler Prime Recalled for Reporting Errors
Siemens Healthcare Diagnostics is recalling Atellica Solution and Sample Handler Prime systems because reporting and conversion factors may not apply to all connected analyzers.
Product
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1448-2018·2018-05-09
Siemens SOMATOM Perspective 16 CT Scanner Recalled for Dose Calculation Error
Siemens is recalling 1,301 SOMATOM Perspective 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.
Product
SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1452-2018·2018-05-09
Siemens SOMATOM Emotion CT Scanner Recalled for Incorrect Dose Calculations
Siemens is recalling 1,301 SOMATOM Emotion CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.
Product
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1453-2018·2018-05-09
Siemens SOMATOM Sensation 10 CT Scanner Recalled for Dose Calculation Error
Siemens Medical Solutions is recalling 1,301 SOMATOM Sensation 10 CT scanners due to a software error that may cause unnecessary radiation exposure during head scans.
Product
SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1595-2018·2018-05-09
Cook Inc. Recalls StoneBreaker C02 Cartridges Due to Sterility Concerns
Cook Inc. is recalling 38,542 StoneBreaker C02 Cartridges because the interior may not be sterilized to the appropriate level when reprocessed.
Product
StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1593-2018·2018-05-09
Cook Inc. Recalls StoneBreaker Probe Caps Due to Sterility Concerns
Cook Inc. is recalling 370 StoneBreaker Probe Caps because the interior may not be properly sterilized during reprocessing.
Product
StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2018·2018-05-09
Cook Inc. Recalls StoneBreaker Exhaust Caps Due to Sterility Concerns
Cook Inc. is recalling 629 StoneBreaker Exhaust Caps because the interior may not be sterilized to the appropriate level when following reprocessing instructions.
Product
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1457-2018·2018-05-09
Siemens SOMATOM Sensation Open CT Scanner Recall for Dose Calculation Error
Siemens is recalling 1,301 SOMATOM Sensation Open CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.
Product
SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1446-2018·2018-05-09
Siemens SOMATOM Emotion 16 CT Scanner Recalled for Dose Calculation Error
Siemens Medical Solutions is recalling 1,301 SOMATOM Emotion 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.
Product
SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1588-2018·2018-05-09
Siemens Atellica IM 1600 Analyzer Recalled for Reporting Factor Errors
Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer systems because reporting and conversion factors may not apply to all connected analyzers.
Product
Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1459-2018·2018-05-09
Siemens SOMATOM Emotion Duo CT Scanner Recalled for Radiation Dose Errors
Siemens is recalling SOMATOM Emotion Duo CT scanners because a software algorithm may calculate incorrect radiation doses for head scans, potentially exposing patients to unnecessary radiation.
Product
SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1454-2018·2018-05-09
Siemens SOMATOM Sensation 16 CT Scanner Recalled for Dose Calculation Errors
Siemens is recalling 1,301 SOMATOM Sensation 16 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.
Product
SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1449-2018·2018-05-09
Siemens SOMATOM Scope CT Scanner Recalled for Incorrect Radiation Dose Calculations
Siemens Medical Solutions is recalling SOMATOM Scope CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially leading to unnecessary radiation exposure.
Product
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Category
Medical Device
Distribution
0 states

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24051–24075 of 40299