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

32776–32800 of 40325

HighFDA (Devices)·Z-1841-2015·2015-07-01
Remel VersaTREK Instrument Series 240 Recalled for False Positive Reports
Remel Inc. is recalling 143 VersaTREK Instrument Series 240 devices because their use may result in false positive reports. The devices are used to cultivate microorganisms from blood and other sterile bodily fluids.
Product
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1819-2015·2015-07-01
Orthofix Centurion POCT System Drill Guide Recall for Depth Setting Risk
Orthofix is recalling 36 Centurion POCT System Drill Guides because the thumb button may remain unlocked, allowing the drill stop to rotate unintentionally and change the depth setting.
Product
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2015·2015-07-01
Unomedical Infusion Set Needles Recalled for Potential Breakage During Use
Unomedical is recalling specific infusion sets because the steel needle can break during use, interrupting medication delivery.
Product
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1837-2015·2015-07-01
DeRoyal Recalls Custom Surgical Kits with Defective Medtronic Gloves
DeRoyal Industries is recalling custom surgical kits containing Medtronic Devon Light Gloves due to splits or holes.
Product
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1822-2015·2015-07-01
Smith & Nephew Recalls Ultra-Fast Fix Knot Pusher Suture Cutters
Smith & Nephew is recalling Ultra-Fast Fix Knot Pusher Suture Cutters because the device's sterility may be compromised.
Product
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1829-2015·2015-07-01
Varian Leipzig-style Brachytherapy Applicator Set Recalled for Dose Rate Discrepancy
Varian Medical Systems is recalling 46 Leipzig-style Surface Applicator Sets because the actual dose rate is approximately 14% higher than the rate published in the Instructions for Use.
Product
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1825-2015·2015-07-01
GE Healthcare T2100 Treadmill Recalled for Uncontrolled Walking Belt Motion
GE Healthcare is recalling 11,423 T2100 Treadmills due to a potential safety issue involving uncontrolled motion of the walking belt.
Product
GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1846-2015·2015-07-01
Siemens Artis zee/zeego Systems Recalled for Position Sensor Fault
Siemens is recalling 475 Artis zee/zeego angiography systems because a position sensor fault could cause the system to exceed its usual speed and collide.
Product
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1842-2015·2015-07-01
Remel VersaTREK Instrument Series 528 Recalled for False Positive Reports
Remel Inc. is recalling 21 VersaTREK Instrument Series 528 devices because their use may result in false positive reports.
Product
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1833-2015·2015-07-01
ArthroCare Medical Recalls PROcise XP Wand Due to Component Failure
ArthroCare Medical is recalling 2,355 PROcise XP Wand units because a potential component failure may cause the device to become inoperable during use.
Product
PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1828-2015·2015-07-01
Terumo Recalls Custom Cardiovascular Procedure Kits and Safety Valves
Terumo is recalling 163 custom cardiovascular procedure kits and over-pressure safety valves because the valves are not cleared for use on the arterial side of the bypass circuit.
Product
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1844-2015·2015-07-01
Volcano PV .035 Catheter Recalled for Incorrect Shelf Life Labeling
Volcano Corporation is recalling 162 PV .035 Catheters because they were labeled with incorrect shelf life dates during a relabeling procedure.
Product
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1832-2015·2015-07-01
ArthroCare EVAC 70 XTRA Plasma Wand Recall for Component Failure
ArthroCare Medical Corporation is recalling EVAC 70 XTRA plasma wands due to potential component failure that may cause the device to become inoperable.
Product
EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1845-2015·2015-07-01
Volcano Prestige Plus J-Tip Wire Recalled for Incorrect Shelf Life Labeling
Volcano Corporation is recalling 162 Prestige Plus 185cm J-Tip pressure wires because they were labeled with incorrect shelf life dates during a relabeling procedure.
Product
Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1824-2015·2015-07-01
CooperSurgical Recalls Vaginal Speculums Due to Incorrect Packaging
CooperSurgical is recalling 9,400 McKesson Medi-Pak Vaginal Speculums because small-sized speculums were incorrectly packaged in bags labeled for medium-sized speculums.
Product
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2015·2015-07-01
Cook Inc. Recalls LapSac Surgical Tissue Pouches Due to Labeling Error
Cook Inc. is recalling 123,184 LapSac Surgical Tissue Pouches because the labeling includes information not stated in the intended use.
Product
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1826-2015·2015-07-01
Merit Medical Prelude Pro Sheath Introducer Recalled for Incorrect Dilator Packaging
Merit Medical Systems is recalling Prelude Pro Sheath Introducers packaged with a 0.035-inch dilator instead of the labeled 0.038-inch size.
Product
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1823-2015·2015-07-01
X Spine Systems Recalls Fortex Pedicle Screw System Rods
X Spine Systems is recalling 75 Fortex Pedicle Screw System Continuous Radius Rods because they measure 45mm instead of the specified 50mm.
Product
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-1843-2015·2015-07-01
Siemens IMMULITE 2000 Italian Cypress Allergy Test Recall
Siemens is recalling specific lots of the IMMULITE 2000 Italian Cypress 3g Allergy test because they fail to meet shelf-life stability specifications.
Product
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum…
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-1839-2015·2015-07-01
Ethicon Recalls Surgical Sutures Due to Incomplete Labeling
Ethicon is recalling specific lots of Fast Absorbing Plain Gut sutures because the box and foil labels are incomplete.
Product
Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1840-2015·2015-07-01
Bio-Rad Anti-HBs Cutoff Calibrator Recalled for Incorrect Expiration Date
Bio-Rad Laboratories is recalling 20 vials of Anti-HBs Cutoff Calibrator because the expiration date printed on the label is incorrect.
Product
The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
Category
Medical Device
Distribution
5 states
CriticalFDA (Devices)·Z-1818-2015·2015-06-24
Hill-Rom Viking Mobile Patient Lifts Recalled for Potential Free Fall Hazard
Hill-Rom is recalling Viking M, L, and XL Mobile Lifts because a damaged actuator can cause the lift arm to drop suddenly, posing a risk of patient injury or death.
Product
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1731-2015·2015-06-24
HeartWare HVAD Recall Issued for Internal Controller Alarm Battery Failures
HeartWare Inc. is recalling HVAD systems due to internal controller alarm battery failures. The recall affects 3,747 currently implanted devices worldwide.
Product
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-1801-2015·2015-06-24
Vidacare T.A.L.O.N Intraosseous Needle Recall for Potential Sterility Breach
Vidacare Corporation is recalling T.A.L.O.N intraosseous needles due to a potential breach in sterility. The recall affects 2,104 boxes distributed in the US and internationally.
Product
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1812-2015·2015-06-24
Intuitive Surgical Recalls 5 mm Thoracic Grasper Due to Coating Damage
Intuitive Surgical is recalling 2,436 units of 5 mm Thoracic Graspers because coating damage could cause fragments to fall into patients.
Product
Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
Category
Medical Device
Distribution
0 states

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32776–32800 of 40325