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

29726–29750 of 40325

HighFDA (Devices)·Z-2093-2016·2016-07-06
Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect
Smith & Nephew is recalling 16 units of the Legion HK Femoral Assembly because the internal surface where cement is applied is below specification.
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2076-2016·2016-07-06
Pentax Ultrasound Bronchoscopes Recalled for Lodged Accessories Risk
Pentax Medical is recalling 115 Ultrasound Bronchoscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2058-2016·2016-07-06
Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage
Hospira is recalling specific PlumSet IV administration sets because intravenous fluid may leak at the CLAVE secondary port.
Product
*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2101-2016·2016-07-06
Medical Depot Recalls Aluminum Crutches Due to Tip Failure
Medical Depot Inc. is recalling 123,125 pairs of aluminum crutches nationwide because the metal tip may fail. Users should stop using the product.
Product
Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2016·2016-07-06
Philips Ingenuity Core MRI Scanner Recalled for Cover Crack Risk
Philips Medical Systems is recalling Ingenuity Core MRI scanners because a thinner plastic cover may crack, posing an injury risk to patients and staff.
Product
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2106-2016·2016-07-06
Medical Depot Aluminum Crutches Recalled Due to Tip Failure
Medical Depot Inc. is recalling 123,125 pairs of Direct Supply aluminum crutches because the metal tips may fail.
Product
Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2066-2016·2016-07-06
Pentax Choledocho-Nephroscope Recalled Due to Lodged Accessories in Instrument Channel
Pentax Medical is recalling 126 Choledocho-Nephroscope units because operational and therapeutic accessories can become lodged in the instrument channel.
Product
Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2081-2016·2016-07-06
Alcon CENTURION Vision System Recalled for Power Switch Defect
Alcon Research, Ltd. is recalling the CENTURION Vision System because the grounding pin in the power entry switch may detach when the AC power cable is removed.
Product
CENTURION Vision System
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2077-2016·2016-07-06
Pentax Ultrasound Gastroscope Recall Due to Lodged Accessories
Pentax Medical Company is recalling ultrasound gastroscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2098-2016·2016-07-06
CMP Industries Recalls Impak Elastic Acrylic Resin Due to Rust
CMP Industries is recalling Impak Elastic Acrylic Resin Powder and Liquid due to the possible presence of foreign material, specifically rust.
Product
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2074-2016·2016-07-06
Pentax Naso-Pharyngo-Laryngoscope Recall Due to Lodged Accessories
Pentax Medical Company is recalling 215 Naso-Pharyngo-Laryngoscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2075-2016·2016-07-06
Pentax Sigmoidoscopes Recalled Due to Risk of Lodged Accessories
Pentax Medical Company is recalling 1,596 sigmoidoscopes because operational and therapeutic accessories can become lodged in the instrument channel.
Product
Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2055-2016·2016-07-06
Hospira Symbiq Infusion Pumps Recalled for Frequent False Occlusion Alarms
Hospira is recalling Symbiq One Channel Infusers due to frequent false proximal occlusion alarms that may delay or interrupt patient therapy.
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2063-2016·2016-07-06
Medtest Homocysteine Reagent Recalled for Performance Deterioration
Medtest Holdings is recalling 13 kits of Liquid Stable 2-Part Homocysteine Reagent due to under-recovery of homocysteine in patient samples.
Product
Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2078-2016·2016-07-06
Pentax Medical Recalls Ureteroscopes Due to Lodged Accessories Risk
Pentax Medical is recalling 32 ureteroscopes because operational accessories may become lodged in the instrument channel.
Product
Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2090-2016·2016-07-06
Smith & Nephew Recalls Legion HK Femoral Assemblies for Surface Defect
Smith & Nephew is recalling 12 units of Legion HK Femoral Assemblies because the internal surface is below specification, potentially affecting cement adhesion.
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2097-2016·2016-07-06
CMP Industries Recalls IMPAK Liquid Acrylic Resin Due to Rust
CMP Industries is recalling 77 units of IMPAK Liquid Acrylic Resin due to the possible presence of foreign material (rust). The affected product is distributed in six US states and Canada.
Product
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML)…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2094-2016·2016-07-06
Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect
Smith & Nephew is recalling 10 units of Legion HK Femoral Assemblies because the internal cement surface is below specification.
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2089-2016·2016-07-06
CMP Industries Recalls IMPAK Liquid Acrylic Resin Due to Rust
CMP Industries is recalling specific lots of IMPAK Liquid Acrylic Resin due to the possible presence of foreign material (rust). The affected products are used for dental applications.
Product
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS &…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2088-2016·2016-07-06
Siemens Syngo.plaza PACS Software Recall for Database Error
Siemens is recalling 74 Syngo.plaza PACS systems due to a software error that may create duplicate image references in the database.
Product
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-2099-2016·2016-07-06
Dako HER2 CISH pharmDx Kit Recalled for Incorrect Probe Concentration
Dako North America Inc. is recalling 31 kits of the HER2 CISH pharmDx Kit because the HER2 probe concentration was too low.
Product
Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2118-2016·2016-07-06
Philips Ingenuity Core 128 CT Scanner Recalled for Image Artifacts
Philips is recalling 19 Ingenuity Core 128 CT scanners because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.
Product
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2095-2016·2016-07-06
Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect
Smith & Nephew is recalling 97 units of the Legion HK Femoral Assembly because the internal surface is below specification, potentially affecting cement adhesion.
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2057-2016·2016-07-06
Dynarex Recalls Specimen Containers Due to Incorrect Sterile Labeling
Dynarex Corporation is recalling non-sterile specimen containers that were mistakenly packed in cartons labeled as sterile. The recall covers specific lots distributed in the US and Canada.
Product
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2091-2016·2016-07-06
Smith & Nephew Recalls Legion Hinge Knee Femoral Assemblies
Smith & Nephew is recalling Legion Hinge Knee femoral assemblies because the cement application surface is below specification.
Product
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
Category
Medical Device
Distribution
Distributed nationwide

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