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

38801–38825 of 40449

HighFDA (Devices)·Z-0920-2013·2013-03-20
Integra CUSA CEM Nosecone Recalled for Potential Tip Erosion
Integra LifeSciences is recalling CEM Nosecones for the CUSA EXcel system due to a potential for tip erosion and breakage. No patient injuries have been reported.
Product
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0926-2013·2013-03-20
Medtronic O-arm Imaging System Recalled for Braking System Failure
Medtronic is recalling 463 O-arm Imaging Systems worldwide due to a potential failure of the braking system controlling vertical gantry movement.
Product
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2013·2013-03-20
Genesys Orthopedic Recalls 3.75mm Fixed Cervical Screws Due to Manufacturing Residue
Genesys Orthopedic Systems is recalling 3.75mm x 12mm Fixed Cervical Screws because manufacturing residue may be present. The residue poses risks of infection, delayed fusion, or revision surgery.
Product
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2013·2013-03-20
GE Healthcare Recalls Cardiovascular X-ray Systems Due to Locking Nut Issue
GE Healthcare is recalling specific cardiovascular X-ray imaging systems because a locking nut on the overhead video monitor suspension might loosen.
Product
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0930-2013·2013-03-20
Siemens ACUSON S2000 ABVS Scanner Recalled for Sharp Transducer Edges
Siemens is recalling 214 ACUSON S2000 ABVS systems because the transducer pod may contain sharp edges that could cause injury.
Product
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0919-2013·2013-03-20
Stryker Howmedica Command Instrument Broach Handle Recalled for Fracture Risk
Stryker Howmedica is recalling 48 Command Instrument Broach Handles used in hip surgery due to reports of handle fracture and component disassociation.
Product
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0922-2013·2013-03-20
Instratek Recalls Endotrig Trigger Release Blades Due to Cannula Advancement Issues
Instratek is recalling 235 Endotrig Trigger Release Sterile Micro Hook Blades because they could not be advanced into the cannula during procedures.
Product
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0938-2013·2013-03-20
Synthes Spine Pedicle Screw Recalled for Incorrect Length Etching
Synthes USA HQ, Inc. is recalling 18 units of 45 mm Click 'X Pedicle Screws because they were incorrectly etched as 40 mm.
Product
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0932-2013·2013-03-20
Spine Smith Partners Recalls Cynch Lordotic T-PLIF Implants Due to Marking Error
Spine Smith Partners LP is recalling three Cynch Lordotic T-PLIF implants distributed in Texas because they were incorrectly laser marked as 23mm instead of 28mm.
Product
Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0951-2013·2013-03-20
Diagnostica Stago Recalls LIATEST VWF:Ag Coagulation Assay Kits
Diagnostica Stago is recalling LIATEST VWF:Ag kits because measurement errors may lead to lowered percentage results.
Product
Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0941-2013·2013-03-20
Synthes Large Combination Clamp Recalled Due to Oversized Hex Nuts
Synthes USA is recalling 136 Large Combination Clamps because oversized hex nuts prevent standard 11 mm sockets and wrenches from fitting.
Product
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0950-2013·2013-03-20
Philips Brilliance 64 and Ingenuity CT Systems Software Update Recall
Philips Medical Systems is recalling 42 Brilliance 64 and Ingenuity CT systems to update software and customer release notes.
Product
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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…
Category
Medical Device
Distribution
19 states
ModerateFDA (Devices)·Z-0942-2013·2013-03-20
Synthes Titanium Midface Distractor Recalled Due to Fit Issues
Synthes USA is recalling 596 Titanium Midface Distractors because oversized tabs may prevent footplates from fitting properly.
Product
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0935-2013·2013-03-20
GE Healthcare Recalls MRI Systems Due to Reporting Tool Error
GE Healthcare is recalling multiple MRI systems because an error in the SR Viewer Reporting Tool allows edits to be saved to incorrect reports.
Product
Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0937-2013·2013-03-20
Vygon Recalls 210 CT PICC Kits Packaged with Incorrect Needles
Vygon Corporation is recalling 210 units of 6F Triple Lumen CT PICC kits because they were packaged with non-safety needles instead of the safety needles indicated on the label.
Product
Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0944-2013·2013-03-20
Smith & Nephew Recalls Mislabelled Trigen Internal Hex Reconstruction Screws
Smith & Nephew is recalling 90 units of Trigen internal hex reconstruction screws because 75 mm and 80 mm lengths were packaged in incorrect boxes and labels.
Product
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0925-2013·2013-03-20
Biomet Recalls Straight Acetabular Inserter Handles Due to Latch Interference
Biomet, Inc. is recalling 58 non-sterile Straight Acetabular Inserter Handles because they may lock onto the cup during surgery, potentially causing delays.
Product
REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0948-2013·2013-03-20
Siemens CT Software Recall for Sporadic 3D Reconstruction Hang-Ups
Siemens Medical Solutions is recalling 896 Somatom CT systems due to sporadic software malfunctions that cause 3D reconstructions to hang during preview.
Product
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0936-2013·2013-03-20
Bacterin Elutia Silicone Surgical Wound Drain Recalled for Cracks
Bacterin International is recalling specific lots of Elutia silicone surgical wound drains because a portion of the drain was found to be cracked.
Product
Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0943-2013·2013-03-20
Smith & Nephew Recalls Mislabelled Trigen Internal Hex Reconstruction Screws
Smith & Nephew is recalling 69 Trigen internal hex reconstruction screws because 75 mm and 80 mm units were packaged in incorrect boxes and labels.
Product
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0924-2013·2013-03-20
Keystone Dental Recalls Mislabeled Genesis Straight Esthetic Abutments
Keystone Dental Inc is recalling 22 units of Genesis Straight Esthetic abutments that were mislabeled with incorrect dimensions.
Product
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0923-2013·2013-03-20
Keystone Dental Recalls Mislabeled Genesis Straight Esthetic Abutments
Keystone Dental Inc is recalling 35 units of Genesis Straight Esthetic abutments because they were mislabeled as 4.0 mm 1 mm cuff units when they are actually 5.0 mm 3 mm cuff units.
Product
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0929-2013·2013-03-20
Abbott Recalls Mislabeled AMO Sensar Intraocular Lenses
Abbott Medical Optics is recalling 155 AMO Sensar Intraocular Lenses because two production orders contained mislabeled units. The lenses are distributed worldwide.
Product
AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0927-2013·2013-03-20
Innominata Lyme Disease Microplate EIA Kit Recalled for Low-Reactivity Issues
Innominata dba GenBio is recalling 195 units of the Anti-Borrelia (Lyme) Microplate EIA Kit due to multiple incidents of low-reacting assay plates.
Product
ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0933-2013·2013-03-20
Siemens Total Iron Binding Capacity Reagent Cartridge Recall for Labeling Error
Siemens is recalling Total Iron Binding Capacity reagent cartridges because the stated analytical sensitivity in the instructions is no longer valid.
Product
Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
Category
Medical Device
Distribution
Distributed nationwide

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38801–38825 of 40449