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

35351–35375 of 40449

HighFDA (Devices)·Z-2116-2014·2014-07-30
Pentax Ultrasound Gastroscopes Recalled Due to Aspiration Needle Derailment Risk
Pentax Medical is recalling 531 ultrasound gastroscopes because aspiration needles may derail from the accessory elevator, posing a risk of patient injury.
Product
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2014·2014-07-30
Heartsine AED Electrode Pouches Recalled for Difficulty Opening
Heartsine is recalling Pad-Pak and Pedi-Pak electrode accessories for the Samaritan PAD 300P and 350P because some sealed foil pouches are difficult to open, potentially delaying therapy.
Product
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2100-2014·2014-07-30
Terumo Recalls Sarns Two-stage Venous Return Cannulae Due to Particulate
Terumo CVS is recalling Sarns Two-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2014·2014-07-30
Philips QLAB 10 Core Module Software Recall for Measurement Defect
Philips Ultrasound is recalling QLAB 10 Core Module software due to a defect that may use incorrect measurement values under specific conditions.
Product
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2114-2014·2014-07-30
GE Healthcare Recalls CARESCAPE Monitor B650 Due to Sound Loss
GE Healthcare is recalling CARESCAPE Monitor B650 units because they may lose alarm sounds when an external display is connected via a USB extender with an active hub.
Product
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2014·2014-07-30
Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect
Teleflex Medical is recalling Hudson RCI breathing circuits because the temperature probe does not properly connect to the temperature port.
Product
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a…
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-2089-2014·2014-07-30
Perouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect
Perouse Medical is voluntarily recalling specific batches of Flamingo Inflation Devices due to a potential water-tightness defect that could allow air entry during cardiovascular procedures.
Product
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2082-2014·2014-07-30
DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty
DePuy Orthopaedics is recalling 814 RECLAIM Taper Protector Sleeves because the product can be difficult to remove from the Distal Stem.
Product
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-2085-2014·2014-07-30
GE Healthcare CARESCAPE Patient Monitors Recalled for Data Loss
GE Healthcare is recalling CARESCAPE B850, B650, and B450 patient monitors because the Patient Data Module may fail to communicate, causing partial loss of monitoring parameters.
Product
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2111-2014·2014-07-30
Siemens syngo Imaging XS Software Recall for Potential Miscalculation
Siemens is recalling syngo Imaging XS software due to potential miscalculation of grey scale values in specific image processing functions.
Product
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2091-2014·2014-07-30
Invacare Recalls M41 Wheelchair Controllers Due to Programming Error
Invacare is recalling 819 M41 powered wheelchair controllers that may cause momentary loss of control due to non-standard factory programming.
Product
MK5 NX Controller--Wheelchair controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2096-2014·2014-07-30
Terumo Recalls Sarns Venous Return Cannulae Due to Loose Fiber Particulate
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2014·2014-07-30
Alphatec Spine Recalls Solanas 2.1mm Fixed Depth Drill
Alphatec Spine is recalling 14 units of the Solanas 2.1mm Fixed Depth Drill because the golden stop slid from its fixed position during use.
Product
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2099-2014·2014-07-30
Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2098-2014·2014-07-30
Terumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate
Terumo CVS is recalling 20 units of Sarns Soft-arc Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2079-2014·2014-07-30
Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Electrolyte Error Codes
Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Lactate Cartridges because they may display error codes for electrolyte parameters.
Product
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2014·2014-07-30
Terumo Recalls Sarns D4 Aortic Arch Cannulae Due to Particulate
Terumo CVS is recalling Sarns D4 Aortic Arch Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2081-2014·2014-07-30
AGFA DX-D 100 X-Ray System Recalled for Touch Screen Malfunction
AGFA Corp. is recalling 216 DX-D 100 digital radiography systems because liquid contact with the touch screen may cause the device to incorrectly recognize user input and alter settings.
Product
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2084-2014·2014-07-30
DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty
DePuy Orthopaedics is recalling RECLAIM Taper Protector Sleeves because they can be difficult to remove from the Distal Stem.
Product
RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-2087-2014·2014-07-30
Synthes Orthopedic Guide Blocks Recalled for Incorrect Labeling
Synthes, Inc. is recalling 180 Guide Blocks for the Volar Distal Radius Plate System due to incorrect package labeling. The physical parts are correctly marked, but the packaging may identify the wrong side.
Product
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2086-2014·2014-07-30
Exactech Recalls NOVATION Femoral Stems Lacking Plasma Coating
Exactech is recalling 10 NOVATION Femoral Stems because they lack the specified plasma coating. The devices were distributed worldwide.
Product
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2106-2014·2014-07-30
Terumo CPB Catheter Kit Recalled for Loose Fiber Particulate
Terumo CVS is recalling 125 CPB Catheter Kits because in-process inspections found loose fiber particulate exceeding specifications.
Product
CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2107-2014·2014-07-30
Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect
Teleflex Medical is recalling 11,679 Hudson RCI Breathing Circuits because the temperature probe does not properly connect to the temperature port.
Product
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for…
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-2097-2014·2014-07-30
Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Particulate
Terumo CVS is recalling Sarns Malleable Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2110-2014·2014-07-30
Philips QLAB 10.1 Software Recalled for Incorrect Measurement Defect
Philips Ultrasound is recalling QLAB 10.1 software because a defect may cause incorrect measurement values under specific conditions.
Product
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Category
Medical Device
Distribution
10 states

How to read this listing

Filters

35351–35375 of 40449