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

37376–37400 of 40449

LowFDA (Devices)·Z-0070-2014·2013-11-06
Zimmer Versys Femoral Stem Recall Due to Packaging Adhesion
Zimmer, Inc. is recalling Versys Beaded Fullcoat Femoral Stems because the packaging bag adheres to the polished device surface.
Product
Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0052-2014·2013-10-30
Siemens Acuson SC2000 Ultrasound Systems Recalled for Inaccurate 3D Images
Siemens is recalling 26 Acuson SC2000 ultrasound systems because a software issue causes inaccurate 3D images, which may lead to ablation in the wrong location.
Product
Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0048-2014·2013-10-30
Abbott Medical Optics Recalls STAR Excimer Laser Systems Due to Component Failure
Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor component failure that affects the lamp and illumination system.
Product
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0058-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may not loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0050-2014·2013-10-30
Convergent Dental Recalls Five Solea 1.0 Laser Surgical Instruments
Convergent Dental is recalling five Solea 1.0 laser surgical instruments due to a defect that could cause unintended laser emission during activation.
Product
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0049-2014·2013-10-30
Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the AC Power Distribution PCB that affects the lamp and illumination system.
Product
STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0055-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring kits because a hex wrench may fail to loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0028-2014·2013-10-30
Becton Dickinson Recalls BBL MGIT Mycobacteria Tubes Due to Barcode Error
Becton Dickinson is recalling 187,000 BBL MGIT Mycobacteria Growth Indicator Tubes because incorrect barcodes may cause false negative test results.
Product
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0047-2014·2013-10-30
Abbott Recalls STAR Excimer Laser Systems Due to Power Component Failure
Abbott Medical Optics is recalling STAR Excimer Laser Systems because a power component failure can cause the lamp and illumination system to malfunction.
Product
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0060-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Hex Wrench Defect
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because a hex wrench may fail to loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0051-2014·2013-10-30
Synergetics 25 Gauge Soft Tip Cannula Recall Due to Gauge Mislabeling
Synergetics Inc is recalling 25 gauge Soft Tip Cannulas because some units are co-mingled with 23 gauge cannulas but labeled as 25 gauge.
Product
Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0045-2014·2013-10-30
Merit Medical Recalls Performa Angiographic Catheters Due to Tip Shape Variation
Merit Medical Systems is recalling 200 units of Performa Angiographic Catheters because four lots contain a catheter with a slight variation in tip shape.
Product
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0034-2014·2013-10-30
GE Healthcare Recalls Centricity Cardio Imaging 5.0 Software
GE Healthcare is recalling Centricity Cardio Imaging 5.0 software due to a potential image labeling error in the Image Viewer that may affect diagnostic interpretation.
Product
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0044-2014·2013-10-30
Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Issue
Advanced Sterilization Products is recalling STERRAD 100NX Cassettes because the leak indicator is effective for only 12 months, not the labeled 15 months.
Product
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0029-2014·2013-10-30
OPTI LION E-Plus Cassettes Recalled for Incorrect Barcode Labeling
OPTI Medical Systems is recalling OPTI LION E-Plus Cassettes because incorrect barcodes may affect performance over time and cause quality control failures.
Product
Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0046-2014·2013-10-30
Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure
Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the power distribution board that affects the lamp and illumination system.
Product
STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0031-2014·2013-10-30
Aesculap Recalls UNITRAC Pneumatic Retraction Arms Due to Safety Instructions
Aesculap, Inc. is recalling 217 UNITRAC Pneumatic Retraction Arms because updated instructions for use are required to ensure safe operation and extend product life.
Product
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0066-2014·2013-10-30
GE Brivo C-Arm X-Ray Recalled for High Voltage Cable Failure
GE is recalling 29 Brivo C-Arm X-ray units because high voltage cable wires may fail, causing loss of system functionality.
Product
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0054-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring kits because a hex wrench may fail to loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0057-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling 109 Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.
Product
Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0059-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0061-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some lots contain a hex wrench that may not loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0030-2014·2013-10-30
Perkin Elmer 226 Sample Collection Device Recall for Glue Contamination
Perkin Elmer is recalling 226 Sample Collection Devices used for newborn screening due to potential glue contamination on the back side.
Product
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0064-2014·2013-10-30
DePuy SmartSet GMV Endurance Gentamicin Bone Cement Recalled for Uncleared Indications
DePuy Orthopaedics is recalling SmartSet GMV Endurance Gentamicin Bone Cement because it is intended for uses not cleared by the FDA.
Product
SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0033-2014·2013-10-30
Philips MRI Systems Recalled for Potential Water Freezing in Venting System
Philips Medical Systems is recalling 511 MRI systems because water may collect and freeze in the vent pipe, potentially blocking the magnet venting system.
Product
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Category
Medical Device
Distribution
Distributed nationwide

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37376–37400 of 40449