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

16476–16500 of 27471

HighFDA (Devices)·Z-0579-2019·2018-12-19
Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.
Product
Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0587-2019·2018-12-19
GE Healthcare Recalls B105/125 Patient Monitors Due to Network Overload Risk
GE Healthcare is recalling 5,516 B105/125 patient monitors worldwide because network configuration issues may cause the devices to restart unexpectedly.
Product
B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0603-2019·2018-12-19
Philips Recalls HeartStart MRx Lithium-Ion Batteries Due to Defective Component
Philips is recalling 1,880 HeartStart MRx lithium-ion batteries because a defective component may prevent the battery from charging or delivering power to the monitor/defibrillator.
Product
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators.
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0593-2019·2018-12-19
St. Jude Medical DBS Leads Recalled for Incorrect Electrode Material
St. Jude Medical is recalling Deep Brain Stimulation leads where the most proximal unsegmented electrode may be made of MP35N instead of the required 90/10 platinum-iridium.
Product
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0564-2019·2018-12-19
CIVCO Needle Guide Bracket Recalled for Puncture Risk
CIVCO is recalling Needle Guide Brackets that may puncture the sterile cover during assembly, potentially compromising sterility.
Product
CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0588-2019·2018-12-19
GE LOGIQ E10 Ultrasound System Recalled for Potential Burn Injury
GE Healthcare is recalling 103 LOGIQ E10 Ultrasound Systems because a trans-esophageal probe may overheat, posing a risk of burn injury to patients.
Product
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0536-2019·2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 8,027 Humeral Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0549-2019·2018-12-12
Invacare Hydraulic Patient Lifts Recalled for Potential Caster Separation
Invacare is recalling 73,703 hydraulic patient lifts because a mounting bolt may loosen, causing the caster to separate and the lift to tilt.
Product
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0463-2019·2018-12-12
GE Healthcare Recalls CARESCAPE R860 Inspiratory Safety Guards
GE Healthcare is recalling CARESCAPE R860 Inspiratory Safety Guards because they may disconnect from the breathing circuit, potentially causing loss of ventilation and hypoxia in patients.
Product
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0544-2019·2018-12-12
Philips Brilliance 40 CT Systems Recalled for Gantry Cover Separation Risk
Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.
Product
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0533-2019·2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 2,080 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0539-2019·2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 3,764 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging seal may compromise sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2019·2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 780 Humeral Guide Wires because creases in the packaging may compromise sterility. The product is a single-use surgical instrument.
Product
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0551-2019·2018-12-12
Capintec Recalls Captus 700 Thyroid Uptake Systems Due to Spring Arm Failure
Capintec Inc is recalling 65 Captus 700 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.
Product
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2019·2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 57,241 Natural Nail System Tear Drop Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2019·2018-12-12
Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 1,676 Pressure Sentinel Guide Wires because creases in the packaging seal may compromise sterility. The defect could increase the risk of infection during orthopaedic surgery.
Product
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0558-2019·2018-12-12
Siemens Artis Zee and Zeego X-ray Systems Recalled for Cooling Hose Leak
Siemens is recalling 64 Artis Zee and Zeego angiography systems due to a possible cooling hose leak that can cause the X-ray tube to overheat and block imaging.
Product
Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0560-2019·2018-12-12
Atrium Medical Recalls 28Fr Thoracic Catheters Due to Seal Defect
Atrium Medical Corporation is recalling 2,930 units of 28Fr PVC Thoracic Catheters due to a seal defect in sterile barrier pouches that could compromise sterility.
Product
Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0534-2019·2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 9,387 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area compromise product sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2019·2018-12-12
Philips Brilliance 16 Slice CT Scanner Recalled for Gantry Cover Separation Risk
Philips Medical Systems is recalling 6,343 Brilliance 16 Slice CT scanners nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.
Product
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0527-2019·2018-12-12
Barco Front Cover Attachment Kit Recalled for Potential Falling Hazard
Barco N.V. is recalling 2,087 MDRC-1119 Front Cover Attachment Kits because metal strips may deform, causing the protective cover to fall.
Product
Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0525-2019·2018-12-12
ASO Recalls Family Wellness Sterile Gauze Pads Due to Sterilization Concerns
ASO, LLC is recalling Family Wellness First Aid Sterile Gauze Pads because they may not be fully sterilized. The affected units were distributed nationwide to ten states.
Product
Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0550-2019·2018-12-12
Capintec Recalls Captus 3000 Thyroid Uptake Systems Due to Spring Arm Failure
Capintec Inc is recalling 385 Captus 3000 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.
Product
Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0531-2019·2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling specific lots of M/DN Intramedullary Fixation Humeral Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0535-2019·2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide

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16476–16500 of 27471