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

12576–12600 of 27470

HighFDA (Devices)·Z-0530-2021·2020-12-09
CME America T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks
CME America is recalling 4,182 T-Syringe Pump T34 units because motor wear may cause silent under-infusion and cleaning fluids may crack hardware.
Product
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2021·2020-12-09
Olympus Ultrasound Endoscope Recall for Infection Risk
Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning instructions.
Product
Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
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
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
HighFDA (Devices)·Z-0457-2021·2020-11-25
Stryker Recalls Osteosynthesis Compression Staple EasyClip Devices
Stryker GmbH is recalling EasyClip and EasyClip Xpress staples due to potential nickel release above safety margins in pediatric patients under 20 kg.
Product
Osteosynthesis Compression Staple EasyClip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2021·2020-11-25
MeritMedical Cultura Flex Swab Recall Due to Tip Breakage Risk
Merit Medical Systems is recalling Cultura Flex Swabs because the flocked tip may break off during use, potentially causing soft tissue injury or treatment delays.
Product
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0449-2021·2020-11-25
Thomas Scientific Recalls Wuxi Nest Patient Specimen Collection Tubes
Thomas Scientific is recalling Wuxi Nest patient specimen collection tubes to replace units manufactured and distributed prior to Enforcement Discretion Approval.
Product
Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0472-2021·2020-11-25
Mako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies
Stryker is recalling Mako MICS Handpieces due to a characterization issue that may cause unsuccessful checkpoint verification or bone cuts differing from the preoperative plan.
Product
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0453-2021·2020-11-25
Cardinal Health Recalls Kangaroo Connect 1000ml Bag Sets Due to Leak Risk
Cardinal Health 200, LLC is recalling Kangaroo Connect 1000ml Bag Sets because the feeding spike sets may leak at the tube and spike connector interface.
Product
Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0442-2021·2020-11-25
GE v|tome|x L Series X-ray Systems Recalled for Warning Signal Defect
GE Inspection Technologies is recalling v|tome|x L Series X-ray systems because pre-warning signals may fail to activate if the warm-up mode is not completed.
Product
v|tome|x L Series non-destructive testing cabinet x-ray systems
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0455-2021·2020-11-25
Merit Medical Cultura Collection and Transport System recall due to swab tip breakage risk
Merit Medical recalls its Cultura Collection and Transport System because the swab tip may break off during sample collection, potentially causing soft tissue injury.
Product
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0461-2021·2020-11-25
Roche Recalls cobas infinity Software Due to Incorrect Validation
Roche Diagnostics is recalling 40 cobas infinity central lab licenses because an erroneous QC status may cause incorrect validation of results.
Product
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0456-2021·2020-11-25
Merit Medical Cultura Collection and Transport System Swab Tip Breakage Recall
Merit Medical is recalling Cultura Collection and Transport Systems because the swab tip may break off during sample collection, potentially causing soft tissue injury.
Product
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911
Category
Medical Device
Distribution
Distributed nationwide

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12576–12600 of 27470