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

32376–32400 of 40449

HighFDA (Devices)·Z-2347-2015·2015-08-12
Merge Hemo System Recalled for Freeze-Up During Cardiac Procedures
Merge Healthcare is recalling 451 Merge Hemo systems used with Masimo PHASEIN modules due to system freeze-ups that required moving patients to other cath labs.
Product
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2015·2015-08-12
Siemens Biograph 64-3R PET/CT Systems Recalled for Missing Locking Ring
Siemens Medical Solutions is recalling Biograph 64-3R TruePoint systems because they may be missing a locking ring on optional ceiling mounts.
Product
Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2332-2015·2015-08-12
Siemens Biograph mCT S(64)-4R PET/CT Systems Recalled for Missing Locking Ring
Siemens Medical Solutions USA Inc. is recalling one Biograph mCT S(64)-4R unit because it may be missing a locking ring on the optional ceiling mount.
Product
Biograph mCT S(64)-4R, Model Number 10248672
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2328-2015·2015-08-12
Philips HeartStart XL+ Defibrillator Recalled for Software and Hardware Issues
Philips is recalling 13,168 HeartStart XL+ defibrillators worldwide due to software and hardware issues that can affect device function.
Product
Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1991-2015·2015-08-12
Olympus Analytical X-ray Systems Recalled for Higher Scatter Readings
Olympus Scientific Solutions Americas is recalling 1,047 Analytical X-ray Systems because scatter readings around the probe head were higher than published specifications for certain samples.
Product
Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-XX-U-EN-EN-AP-SP10. Mobile X-ray System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2337-2015·2015-08-12
Siemens Biograph 64-4R CT Systems Recalled for Missing Locking Ring
Siemens Medical Solutions USA Inc. is recalling two Biograph 64-4R CT systems because they may be missing a locking ring on optional ceiling mounts.
Product
Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2333-2015·2015-08-12
Siemens Biograph mCT X-4R Systems Recalled for Missing Locking Ring
Siemens Medical Solutions is recalling two Biograph mCT X-4R systems because they may be missing a locking ring on optional ceiling mounts.
Product
Biograph mCT X-4R, Model Number 10248670
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2349-2015·2015-08-12
Zimmer Surgical Recalls Tourniquet Cuffs with Missing Instructions
Zimmer Surgical Inc. is recalling 330 units of 30-inch tourniquet cuffs because the instructions for use were missing usage instructions and warnings.
Product
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder…
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-2341-2015·2015-08-12
Siemens Artis Q Systems Recalled for Potential Liquid Ingress
Siemens Medical Solutions is recalling Artis Q angiography systems because liquid may seep through the top cover, potentially disabling table movements. No injuries have been reported.
Product
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2336-2015·2015-08-12
Siemens Biograph 6-4R CT Systems Recalled for Missing Locking Ring
Siemens Medical Solutions is recalling specific Biograph 6-4R CT systems because they may be missing a locking ring on optional ceiling mounts.
Product
Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2346-2015·2015-08-12
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter Recall
Atrium Medical Corporation is recalling 620 units of 36Fr Right Angled Firm PVC Thoracic Catheters due to incorrect labeling on inner pouches.
Product
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2335-2015·2015-08-12
Siemens Biograph mCT Flow Edge-4R Systems Recalled for Missing Locking Ring
Siemens Medical Solutions is recalling three Biograph mCT Flow Edge-4R systems because they may be missing a locking ring on optional ceiling mounts.
Product
Biograph mCT Flow Edge-4R, Model Number 10528955
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2330-2015·2015-08-12
Roche Cobas b 221 S2 Fluid Pack Recall for Transponder Error
Roche is recalling S2 Fluid Packs for the Cobas b 221 system because they may generate a transponder error, preventing the instrument from starting measurements.
Product
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized…
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-2339-2015·2015-08-12
GE Healthcare Recalls MRI Scanners Due to Potential Image Orientation Errors
GE Healthcare is recalling 82 MRI scanners because a missing spacer may cause images to be flipped left-right with incorrect orientation annotations.
Product
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2348-2015·2015-08-12
Zimmer Surgical Recalls Tourniquet Cuffs Due to Missing Instructions
Zimmer Surgical Inc. is recalling 61 units of 18-inch disposable tourniquet cuffs because the folded instructions for use pamphlet was missing usage instructions and warnings.
Product
18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder…
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-2209-2015·2015-08-05
Skeletal Kinetics Recalls InjectionPlasty 1.0 Bone Void Filler Kits
Skeletal Kinetics is recalling 67 kits of InjectionPlasty 1.0 Bone Void Filler due to reports of venous uptake, DVT, and pulmonary embolism in implanted patients.
Product
InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary components for mixing and delivery of the bone void filler. The InjectionPlasty…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2271-2015·2015-08-05
Draeger Fabius MRI Anesthesia Machine Recalled for Magnetic Field Attraction
Draeger Medical is recalling 373 Fabius MRI anesthesia machines because their parts can be loosened by the magnetic field of MRI equipment.
Product
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2259-2015·2015-08-05
Philips Ingenuity CT Scanners Recalled for Software and Hardware Defects
Philips is recalling 159 Ingenuity CT scanners due to software errors affecting dose control, image artifacts, and heart rate measurement.
Product
Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2298-2015·2015-08-05
Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 70 G1 dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.
Product
ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-2245-2015·2015-08-05
EXP Pharmaceutical Services Recalls TAUT Intraducer Peritoneal Catheters
EXP Pharmaceutical Services Corp is recalling TAUT Intraducer Peritoneal Catheters because the company failed to register as a medical device establishment or maintain its own quality system.
Product
Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2261-2015·2015-08-05
Otto Bock Recalls Pheon 3R62 Polycentric Prosthetic Knee Joints
Otto Bock Healthcare GmbH is voluntarily recalling 3R62 Pheon prosthetic knee joints because the locking function may fail, potentially causing a fall.
Product
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2305-2015·2015-08-05
Anspach G1 Dissection Tools Recalled Due to Inconsistent Shaft Exposure Labeling
The Anspach Effort, Inc. is recalling 70 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure than specified.
Product
ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-2310-2015·2015-08-05
Anspach Diamond Ball Dissection Tools Recalled for Inconsistent Shaft Exposure
The Anspach Effort, Inc. is recalling 70 Anspach 5MM Diamond Ball dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.
Product
ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-2057-2015·2015-08-05
Hamilton-G5 Ventilators Recalled for Display Freeze Issue
Hamilton Medical is recalling 248 Hamilton-G5 ventilators because the display can freeze, preventing users from operating the device while ventilation continues.
Product
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2268-2015·2015-08-05
OxiMax N-560 Pulse Oximeters Recalled for Display Segment Defects
The FDA is recalling OxiMax N-560 Pulse Oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.
Product
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Category
Medical Device
Distribution
Distributed nationwide

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32376–32400 of 40449