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

28876–28900 of 40357

ModerateFDA (Devices)·Z-2916-2016·2016-10-12
New Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors
New Star Lasers is recalling five ReNew laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
Product
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0050-2017·2016-10-12
Randox IgE Calibrator Series Recall for Value Alignment
Randox Laboratories is recalling IgE Calibrator Series units to align value assignments with the 3rd International Standard for human serum IgE.
Product
IgE Calibrator Series
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2914-2016·2016-10-12
New Star Lasers Recalls CT3Plus and CT3PZ Systems for Labeling Issues
New Star Lasers is recalling 91 CT3Plus and CT3PZ laser systems because customers were not notified when promotional labeling was revised to remove outside-use indications.
Product
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0034-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color D2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 40 units of Zenostar MT Color D2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0022-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling Zenostar MT Color A2 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0021-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling Zenostar MT Color A1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0030-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C1 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 37 units of Zenostar MT Color C1 dental porcelain coloring liquid because packaging leaks may cause skin irritation.
Product
Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2907-2016·2016-10-12
Integra Lumbar Drainage Set Recalled for Incomplete Packaging Seal
Integra LifeSciences is recalling 18 units of Integral Lumbar Drainage Sets due to incomplete sterile packaging seals discovered during final inspection.
Product
Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0010-2017·2016-10-12
Philips CT Scanner Recall for Infant Head Image Quality Defects
Philips is recalling 358 Ingenuity Core CT scanners because infant head scans may show degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0011-2017·2016-10-12
Philips Ingenuity Core 128 CT Scanner Recalled for Image Quality Defects
Philips Medical Systems is recalling 524 Ingenuity Core 128 CT scanners because high-resolution head scans may produce degraded image quality, including non-uniformity and CT number shifts.
Product
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0046-2017·2016-10-12
Toshiba Aquilion Lightning CT Scanner Recalled for Reconstruction Error
Toshiba is recalling 165 Aquilion Lightning CT scanners because a reconstruction error may interrupt scanning if the scan range exceeds the maximum Field of View.
Product
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Category
Medical Device
Distribution
35 states
ModerateFDA (Devices)·Z-2910-2016·2016-10-12
Integra Lumbar Drainage Set Recalled Due to Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling specific lots of Lumbar Drainage Sets because final inspection revealed an incomplete packaging seal on the sterile product.
Product
Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. External drainag system is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch. One (1)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0037-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Orange Dental Porcelain
Ivoclar Vivadent is recalling 5 units of Zenostar MT Color Impulse orange dental porcelain due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0031-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color C2 Dental Porcelain Coloring Liquid
Ivoclar Vivadent is recalling 19 units of Zenostar MT Color C2 dental porcelain coloring liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2915-2016·2016-10-12
New Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure
New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
Product
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0029-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color B4 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 7 units of Zenostar MT Color B4 dental porcelain liquid due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2911-2016·2016-10-12
Arrow Recalls Walrus Arterial Embolectomy Catheters Due to Labeling Errors
Arrow International Inc is recalling 2,425 Walrus Arterial Embolectomy Catheters nationwide due to incorrect labeling.
Product
Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0020-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Violet Due to Packaging Leaks
Ivoclar Vivadent is recalling 25 units of Zenostar MT Color Impulse violet dental porcelain coloring due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0025-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color A4 Dental Porcelain Liquid
Ivoclar Vivadent is recalling 11 units of Zenostar MT Color A4 dental porcelain liquid due to potential packaging leaks that may cause skin irritation.
Product
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0009-2017·2016-10-12
Philips Brilliance 64 CT Scanner Recalled for Infant Head Image Quality Issues
Philips Medical Systems is recalling 185 Brilliance 64 CT scanners because infant head scans in High Resolution mode may show degraded image quality.
Product
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2017·2016-10-12
Merit Medical Recalls Inflation Syringe Kits Due to Labeling Errors
Merit Medical Systems is voluntarily recalling 1,297 Inflation Syringe Kits because unit labels are missing required device information.
Product
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0019-2017·2016-10-12
Ivoclar Vivadent Recalls Zenostar MT Color Impulse Grey Dental Porcelain
Ivoclar Vivadent is recalling 60 units of Zenostar MT Color Impulse grey dental porcelain due to packaging leaks that may cause skin irritation.
Product
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0001-2017·2016-10-12
Terumo CDI H/S Cuvette Recall Due to Connection Error
Terumo is recalling CDI H/S Cuvettes because they may fail to connect to the probe, causing the monitor to display an error and preventing blood parameter display.
Product
CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2912-2016·2016-10-12
Siemens RAPIDPoint 400 Cartridges Recalled for Chloride Calibration Error
Siemens is recalling RAPIDPoint 400 Measurement Cartridges because of an error in the value assignment for Chloride calibrators.
Product
Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2913-2016·2016-10-12
Siemens RAPIDPoint 405 Cartridges Recalled for Chloride Calibration Error
Siemens Healthcare Diagnostics is recalling RAPIDPoint 405 Measurement Cartridges due to an error in the value assignment for Chloride calibrators.
Product
Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
Category
Medical Device
Distribution
Distributed nationwide

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