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

33076–33100 of 40449

HighFDA (Devices)·Z-1640-2015·2015-05-27
Richard-Allan Scientific Recalls Mucolexx Mucolytic Agent Due to Fungal Contamination
Richard-Allan Scientific is recalling Mucolexx mucolytic agent and Mucolexx products after a customer reported fungal contamination in two lots.
Product
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1620-2015·2015-05-27
Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction
Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speaker malfunctions.
Product
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1634-2015·2015-05-27
Stryker Scorpio femoral component recall due to blister seal strength
Stryker Howmedica Osteonics is recalling 1,147 Scorpio femoral components because the inner blister peel strength may be below validated requirements, potentially affecting sterile barrier shelf life.
Product
Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1632-2015·2015-05-27
Philips EPIQ 7 Ultrasound System Recalled for Unit Conversion Error
Philips is recalling EPIQ 7 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations.
Product
EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1)…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1635-2015·2015-05-27
Stryker Triathlon Femoral Component Recalled for Sterile Barrier Seal Issues
Stryker Howmedica Osteonics is recalling 1,147 Triathlon femoral components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.
Product
Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1633-2015·2015-05-27
Stryker Howmedica Hip Prosthesis Components Recalled for Seal Defects
Stryker Howmedica is recalling 1,147 RESTORATION Acetabular Augment System components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.
Product
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1621-2015·2015-05-27
bioMerieux MYLA Server Software Recalled for Processing Failures
bioMerieux is recalling MYLA V3 server software because it may stop processing data in high-volume settings, requiring remote or on-site service.
Product
MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1626-2015·2015-05-27
Wright Medical Recalls Phalinx Hammertoe Handles Due to Incorrect Laser Etching
Wright Medical Technology is recalling 124 units of Phalinx Hammertoe Handles because the term DORSAL was laser etched on the incorrect side.
Product
PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1636-2015·2015-05-27
MelaFind Device Recalled for Unapproved User Interface Data Display
MELA Sciences is recalling 65 MelaFind devices because the probability and histogram data displayed in the user interface lacks FDA approval.
Product
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Category
Medical Device
Distribution
21 states
ModerateFDA (Devices)·Z-1627-2015·2015-05-27
Wright Medical Recalls PHALINX Hammertoe Handles Due to Incorrect Laser Etching
Wright Medical Technology is recalling 126 units of PHALINX Hammertoe Handles because the term 'DORSAL' was laser etched on the incorrect side.
Product
PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1554-2015·2015-05-27
Philips DigitalDiagnost X-Ray System Recalled for Missing Exposure Beep Signal
Philips Medical Systems is recalling 54 DigitalDiagnost X-Ray systems because they fail to emit a beep signal after exposure if powered on for over 12 hours.
Product
Philips Healthcare DigitalDiagnost System X-Ray
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1618-2015·2015-05-27
Integra Recalls Camino ICP Monitors Due to Speaker Malfunction
Integra LifeSciences is recalling Camino ICP Monitors because the audible speaker may malfunction. The recall covers 1,482 units distributed worldwide.
Product
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1619-2015·2015-05-27
Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction
Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speakers may malfunction.
Product
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1625-2015·2015-05-27
Wright Medical Recalls Phalinx Hammertoe Handle Due to Incorrect Etching
Wright Medical Technology is recalling 121 units of Phalinx Hammertoe Handles because the word 'DORSAL' was laser-etched on the incorrect side.
Product
PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1555-2015·2015-05-27
Philips DuraDiagnost X-Ray System Recalled for Missing Exposure Beep
Philips Medical Systems is recalling DuraDiagnost X-ray systems because they may fail to emit a termination beep after 12 hours of operation, violating safety regulations.
Product
Philips Healthcare DuraDiagnost X- Ray
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1624-2015·2015-05-27
Wright Medical Recalls Phalinx Hammertoe Handles Due to Incorrect Laser Etching
Wright Medical Technology is recalling 126 units of Phalinx Hammertoe Handles because the term DORSAL was laser etched on the incorrect side.
Product
PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1630-2015·2015-05-27
CooperSurgical Recalls Carter-Thomason II Port Closure System Due to Printing Defect
CooperSurgical is recalling 430 units of the Carter-Thomason II Port Closure System because pad printing on the suture guide may flake off.
Product
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1606-2015·2015-05-20
GE Healthcare Recalls CARESCAPE Bx50 Monitors for Pacemaker Detection Defect
GE Healthcare is recalling 110 CARESCAPE Bx50 monitors because they may fail to indicate when pacemaker detection is off, potentially delaying treatment for asystole.
Product
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1604-2015·2015-05-20
HeartWare HVAD Pump Driveline Splice Kit Recalled for Failure Risk
HeartWare Inc is recalling HVAD Pump Driveline Splice Kits because they may fail if exposed to excessive force. The recall affects 35 units distributed in the US and several international countries.
Product
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1616-2015·2015-05-20
Beckman Coulter Recalls DxH Diluent Due to Hemoglobin Chamber Compromise
Beckman Coulter is recalling specific lots of COULTER DxH Diluent because increased complaints indicate the product may compromise the hemoglobin chamber in certain blood analysis systems.
Product
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1599-2015·2015-05-20
FDA Recalls VenaSeal Vascular Closure Systems Due to Sterility Concerns
The FDA is recalling VenaSeal vascular closure systems because a possible sterility breach in the outer packaging may compromise the device's sterility.
Product
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1598-2015·2015-05-20
Philips ADAC Vertex Gamma Cameras Recalled for Mechanical Drift Hazard
Philips Medical Systems is recalling 918 ADAC Vertex Gamma Cameras because detector heads may drift and contact patients during imaging.
Product
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1608-2015·2015-05-20
Spacelabs qube Compact Monitor Recalled for Power Failure Risk
Spacelabs Healthcare is recalling five qube Compact Monitors because the input power can fail or the device may not turn on.
Product
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1611-2015·2015-05-20
Fujifilm Synapse Cardiovascular Software Recalled for Inaccurate EMR Measurements
Fujifilm Medical Systems is recalling Synapse Cardiovascular software because measurement values in the EMR may not match clinical reports.
Product
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1613-2015·2015-05-20
Handicare ReTurn Patient Transfer Belt Recalled for Torn Seams
Handicare USA is recalling 64 units of ReTurn patient transfer belts because the heat-welded seam on the strap tore when force was applied.
Product
ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
Category
Medical Device
Distribution
5 states

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33076–33100 of 40449