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

15676–15700 of 39988

LowFDA (Devices)·Z-0512-2021·2020-12-09
Talladium Luminesse ML PMMA Milling Blank Recall for Incorrect Label
Talladium Inc is recalling 10 units of Luminesse ML PMMA milling blanks due to incorrect labels that may cause compatibility issues with milling machines.
Product
Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0484-2021·2020-12-02
Hill-Rom Recalls Life2000 Ventilation Systems Due to Fire Risk
Hill-Rom is recalling 67 Life2000 Ventilation Systems because they pose a risk of fire under certain conditions. The devices are used in home and institutional settings.
Product
Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0491-2021·2020-12-02
FDA Recalls Geistlich Bio-Oss Pen Due to Granule Expulsion Risk
Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen units because granules may be expelled all at once, posing a risk of tissue injury.
Product
Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0475-2021·2020-12-02
Conformis Recalls iTotal Hip Replacement System Due to Incorrect Components
Conformis, Inc. is recalling two iTotal Hip Replacement Systems because incorrect hip components were provided in the kits.
Product
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0483-2021·2020-12-02
Bayer Recalls MEDRAD Stellant FLEX Syringe Kits Due to Cracks
Bayer Medical Care is recalling specific lots of MEDRAD Stellant FLEX 150 mL syringe kits because they may have holes or cracks that allow fluid to leak.
Product
Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0497-2021·2020-12-02
Flexicare ProVu Video Stylet Recalled for Potential Airway Occlusion
Flexicare Medical Ltd. is recalling ProVu Single Use Video Stylets with ET Tubes because over-inflated cuffs may block the airway, making it difficult to ventilate patients.
Product
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0482-2021·2020-12-02
ViewRay MRIdian Linac System Recalled for Potential Burn Injury Risk
Viewray, Inc. is recalling 35 ViewRay MRIdian Linac Systems because receive coil components may reach elevated temperatures, posing a risk of burn injury to patients or users.
Product
ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0492-2021·2020-12-02
Geistlich Bio-Oss Pen Recalled Due to Granule Expulsion Risk
Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen 1-2mm 0.5g units because granules may be expelled all at once, posing a risk of tissue injury.
Product
Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0490-2021·2020-12-02
FDA Recalls Geistlich Bio-Oss Pen Due to Granule Expulsion Risk
Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen units because granules may be expelled all at once, posing a risk of tissue injury.
Product
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0488-2021·2020-12-02
Coloplast Titan Pump Recall for Potential Device Fracture
Coloplast is recalling 8,962 Titan Pump units due to a potential increased occurrence of pump fracture over the device's lifetime.
Product
Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0478-2021·2020-12-02
RayStation software recall for potential incorrect treatment plan references
RaySearch Laboratories is recalling RayStation software because missing data may cause treatment plans to reference incorrect regions or points of interest.
Product
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0485-2021·2020-12-02
Mevion Proton Radiation Treatment System Recalled for Screen Display Failure
Mevion Medical Systems is recalling eight MEVION S250 and S250i proton radiation treatment systems because treatment beam information may disappear from the console screen while the beam continues to deliver.
Product
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2021·2020-12-02
Intuitive Surgical Recalls ION Fully Articulating Catheters Due to Tip Ring Risk
Intuitive Surgical is recalling 454 ION Fully Articulating Catheters because the distal tip ring may become dislodged during use.
Product
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0481-2021·2020-12-02
ViewRay MRIdian System Recalled for Potential Burn Injury Risk
ViewRay is recalling three MRIdian systems because receive coil components may reach elevated temperatures, posing a potential risk of burn injury to patients or users.
Product
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0493-2021·2020-12-02
Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recalled for Seal Defects
Medtronic is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe due to potential defects in the sterile barrier pouch seals.
Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0496-2021·2020-12-02
Medtronic Recalls CryoFlex Surgical Ablation Probes Due to Seal Defects
Medtronic is recalling 3 units of Cardioblate CryoFlex Surgical Ablation Probes because of a potential defect in the sterile barrier pouch seals.
Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0479-2021·2020-12-02
Encore Medical Recalls EMPOWR Partial Knee Peg Drill Guide
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill Guide because the drill shaft may bind during use, potentially delaying surgery.
Product
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0494-2021·2020-12-02
Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
Medtronic is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0477-2021·2020-12-02
Luminex Recalls Verigene Processor SP Due to Unapproved Test Fixtures
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.
Product
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0480-2021·2020-12-02
Encore Medical Recalls EMPOWR Partial Knee Peg Drill Due to Binding
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill because the shaft may bind within the guide, potentially delaying surgery.
Product
EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-0486-2021·2020-12-02
Advanced Bionics Recalls Mislabelled PowerCel 230 Cochlear Implant Batteries
Advanced Bionics is recalling 53 PowerCel 230 batteries for cochlear implants because they may be mislabeled with incorrect battery life information.
Product
AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0495-2021·2020-12-02
Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
Medtronic is recalling 15 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
Product
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0476-2021·2020-12-02
Luminex Recalls Verigene Processor SP Due to Unapproved Service Fixtures
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate and verify the devices.
Product
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0487-2021·2020-12-02
Advanced Bionics Recalls 28 Mislabelled Cochlear Implant Batteries
Advanced Bionics is recalling 28 AB PowerCel 170 batteries due to mislabeling that may indicate incorrect battery life.
Product
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260). For cochlear implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0452-2021·2020-11-25
Cardinal Health Recalls Kangaroo Connect 500ml Bag Sets Due to Leakage
Cardinal Health is recalling Kangaroo Connect 500ml Bag Sets because they may leak at the tube and spike connector interface.
Product
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Category
Medical Device
Distribution
Distributed nationwide

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15676–15700 of 39988