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

29826–29850 of 40449

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
ModerateFDA (Devices)·Z-2110-2016·2016-07-06
Philips Big Bore Radiology Scanner Recalled for Incorrect Screw Material
Philips is recalling 89 Big Bore Radiology scanners because adjustment plate screws were made of stainless steel instead of the specified alloy steel.
Product
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology 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…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2117-2016·2016-07-06
Philips Ingenuity Core CT Systems Recalled for Image Artifacts
Philips is recalling 18 Ingenuity Core CT systems because software version 3.5.4 may cause swirl-like artifacts on images, potentially requiring patient rescans.
Product
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core 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 angles…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2112-2016·2016-07-06
Philips Brilliance iCT Scanner Recall Due to Cracking Cover
Philips is recalling Brilliance iCT scanners because a design change resulted in a thinner plastic cover that may crack.
Product
Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2107-2016·2016-07-06
Siemens Recalls SYNGO Breast Care Software Due to Display Issues
Siemens is voluntarily recalling 29 units of SYNGO Breast Care software because patient information can obscure view markers and facility details are not shown by default.
Product
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-2084-2016·2016-07-06
Integra LifeSciences Recalls METASURG Capture Screw System K-wires
Integra LifeSciences is recalling 182 K-wires used in the METASURG Capture Screw System because they do not meet material, surface, and dimensional specifications.
Product
K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2086-2016·2016-07-06
Integra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error
Integra LifeSciences is recalling 12 units of the Cadence Size 5 Left Tibial Tray Implant because the outer package label incorrectly identifies the material as Cobalt Chromium instead of Titanium.
Product
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2116-2016·2016-07-06
Philips Brilliance 64 CT Scanner Recall for Image Artifacts
Philips is recalling 94 Brilliance 64 CT scanners due to intermittent swirl-like ring artifacts on images, which may require patient rescans.
Product
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 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 angles…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2109-2016·2016-07-06
Philips Big Bore Oncology Scanner Recalled for Incorrect Screw Material
Philips is recalling 47 Big Bore Oncology scanners because the socket head cap screws in the Z-Axis Adjustment Plate were made of stainless steel instead of the specified alloy steel.
Product
Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology 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…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2051-2016·2016-07-06
Cardiovascular Systems Recalls ViperWire Advance Peripheral Guide Wire Due to Missing Date
Cardiovascular Systems Inc is recalling ViperWire Advance Peripheral Guide Wire because the pouch label was missing the use-by date.
Product
ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2047-2016·2016-06-29
Ceg Enterprises Recalls Germ Terminator Toothbrush Sanitizers Due to Heat and Cord Issues
Ceg Enterprises is recalling Germ Terminator GT100 toothbrush sanitizers due to reports of excessive heat, power cord discoloration, and suspected counterfeit UL labels.
Product
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying…
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2040-2016·2016-06-29
Immuno-Mycologics Recalls Histoplasma Yeast Complement Fixation Antigen Due to Bacterial Contamination
Immuno-Mycologics, Inc. is recalling 467 units of Histoplasma Yeast Complement Fixation Antigen Dilute (Lot 111WH3) due to bacterial contamination. The product was distributed nationwide to specific states.
Product
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2017-2016·2016-06-29
Siemens Biograph PET/CT Scanner Upgrade Recalled for Calibration Error
Siemens Medical Solutions is recalling 2 Biograph TruePoint scanner upgrades because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide

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29826–29850 of 40449