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

21376–21400 of 27663

HighFDA (Devices)·Z-2087-2016·2016-07-06
Siemens Hettich Centrifuge Modules Recalled for Premature Bucket Failures
Siemens Healthcare Diagnostics Inc. is recalling 487 Hettich Centrifuge Modules due to premature bucket failures. The units were distributed nationwide.
Product
Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2016·2016-07-06
Medical Depot Recalls Aluminum Crutches Due to Tip Failure
Medical Depot Inc. is recalling 123,125 pairs of Universal Quick Adjust aluminum crutches because the metal tips may fail.
Product
Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall 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-2103-2016·2016-07-06
Medical Depot Universal Aluminum Crutches Recalled for Tip Failure
Medical Depot Inc. is recalling 123,125 pairs of Universal aluminum crutches because the bottom metal tips may fail.
Product
Universal aluminum crutch, 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-2080-2016·2016-07-06
Pentax Small Bowel Scope Recall Due to Lodged Accessories
Pentax Medical Company is recalling 96 Small Bowel Scopes because operational and cleaning accessories can become lodged in the instrument channel.
Product
Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2102-2016·2016-07-06
Medical Depot Recalls EZ Adjust Aluminum Crutches Due to Tip Failure
Medical Depot Inc. is recalling 123,125 pairs of EZ adjust aluminum crutches because the tip may fail, posing a risk of injury.
Product
EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2059-2016·2016-07-06
Hospira Recalls LifeShield IV Administration Sets Due to Fluid Leakage
Hospira is recalling specific LifeShield IV administration sets because intravenous fluid may leak at the CLAVE secondary port.
Product
*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2111-2016·2016-07-06
Philips CT Scanner Recall Due to Potential Cover Cracking Hazard
Philips is recalling three Brilliance CT Big Bore Oncology scanners because a thinner plastic cover may crack and cause injury to patients or staff.
Product
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2068-2016·2016-07-06
Pentax Medical Recalls Colonoscopes Due to Lodged Accessories
Pentax Medical is recalling 12,412 colonoscopes because operational and cleaning accessories can become lodged in the instrument channel.
Product
Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2061-2016·2016-07-06
Hospira Recalls IV Administration Sets Due to Fluid Leakage Risk
Hospira is recalling specific lots of Lifeshield IV administration sets because intravenous fluid may leak at the secondary port.
Product
*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2071-2016·2016-07-06
Pentax Recalls 9,669 Gastroscope Units Due to Lodged Accessories
Pentax Medical is recalling 9,669 gastroscope units because operational or cleaning accessories can become lodged in the instrument channel.
Product
Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth…
Category
Medical Device
Distribution
2 states
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

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21376–21400 of 27663