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

23951–23975 of 40175

ModerateFDA (Devices)·Z-1632-2018·2018-05-16
Michigan Instruments Recalls Thumper Cardiopulmonary Resuscitator Due to Valve Defect
Michigan Instruments is recalling 38 Thumper Cardiopulmonary Resuscitators because a valve defect may prevent the device from delivering chest compression depth.
Product
Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1760-2018·2018-05-16
Bard POWERPORT ClearVUE Implantable Port Recalled for Incorrect Instructions
Bard Peripheral Vascular Inc is recalling 359 units of POWERPORT ClearVUE implantable ports because the included patient ID card contains incorrect flushing instructions.
Product
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1757-2018·2018-05-16
Tornier Aequalis Humeral Nail Drill Bit Recall for Packaging Defect
Tornier is recalling Aequalis Humeral Nail Drill Bits because the tips may puncture sterile packaging, potentially compromising sterility.
Product
AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1744-2018·2018-05-16
Hyphen BioMed Recalls ZYMUTEST HIA IgGAM Assay Kits Due to Incorrect Package Insert
Hyphen BioMed is recalling 281 units of the ZYMUTEST HIA IgGAM assay because the package insert incorrectly states the kits can be used with serum and other fluids, when they should only be used with plasma.
Product
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1656-2018·2018-05-16
Siemens Dimension Vista ALTI Assay Recalled for Drug Interference
Siemens is recalling Dimension Vista ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Product
Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1800-2018·2018-05-16
Siemens Healthcare Recalls EMIT II Plus 6-Acetyl Morphine Reagents
Siemens Healthcare Diagnostics is recalling EMIT II Plus 6-Acetyl Morphine reagents due to incorrect calibrator levels listed in the calibration steps.
Product
Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-1780-2018·2018-05-16
MHC Medical Recalls EasyTouch Insulin Syringes Due to Labeling Error
MHC Medical Products LLC is recalling 46,600 EasyTouch insulin syringes because retail shelf cartons may display an incorrect lot number.
Product
EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1799-2018·2018-05-16
Siemens Syva EMIT II Plus 6-Acetylmorphine Recalled for Calibration Error
Siemens Healthcare Diagnostics is recalling Syva EMIT II Plus 6-Acetylmorphine reagents because the calibrator level listed in the qualitative calibration steps is incorrect.
Product
Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-1603-2018·2018-05-09
Philips MultiDim Eleva Imaging System Recalled for Uncontrolled Table Rotation
Philips is recalling 184 MultiDim Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.
Product
MultiDim Eleva 708032 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-1605-2018·2018-05-09
Philips MultiDiagnost Eleva Imaging System Recalled for Uncontrolled Table Rotation
Philips is recalling 37 MultiDiagnost Eleva imaging systems because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.
Product
MultiDiagnost Eleva 708036 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-1541-2018·2018-05-09
PerkinElmer Specimen Gate Screening Center Software Recall for Data Errors
PerkinElmer is recalling Specimen Gate Screening Center software due to potential errors in neonatal screening results, including false negatives and positives.
Product
Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1607-2018·2018-05-09
Philips MD-Eleva Medical Imaging System Recalled for Tilt Actuator Failure
Philips is recalling 199 MD-Eleva imaging systems because a tilt actuator may break, causing the table to rotate uncontrollably at high speed.
Product
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 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-1606-2018·2018-05-09
Philips MD-Eleva Imaging System Recalled for Uncontrolled Table Rotation
Philips is recalling 206 MD-Eleva imaging systems because the tilt actuator fixation may break, causing the table to rotate uncontrollably at high speed.
Product
Mutlidiagnost-Eleva with Flat Detector 708034 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-1538-2018·2018-05-09
Zimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors
Zimmer Biomet is recalling 18 modular hip head components because two lots of different sizes were potentially commingled. This may lead to the use of an incorrect sized head.
Product
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1609-2018·2018-05-09
Philips MultiDiagnostic-Eleva Imaging System Recalled Due to Uncontrolled Table Rotation
Philips is recalling the MultiDiagnostic-Eleva imaging system because a broken actuator fixation can cause the patient table to rotate uncontrollably at high speed.
Product
MultiDiagnostic-Eleva with Flat Detector 708035 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-1585-2018·2018-05-09
Hitachi MHI-TM2000 Linear Accelerator Recalled for Software Anomaly
Hitachi is recalling one MHI-TM2000 Linear Accelerator System in New York due to a software anomaly that may prevent patient positioning correction, potentially irradiating the wrong body part.
Product
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1608-2018·2018-05-09
Philips MultiDiagnostic-Eleva Recalled Due to Uncontrolled Table Rotation Hazard
Philips Medical Systems is recalling 184 MultiDiagnostic-Eleva systems because a broken actuator fixation can cause the table to rotate uncontrollably at high speed.
Product
MultiDiagnostic-Eleva with Flat Detector 708038 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-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

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