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

15851–15875 of 40287

HighFDA (Devices)·Z-0528-2021·2020-12-09
CME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks
CME America is recalling 4,182 Neofeed syringe pumps because motor wear may cause under-infusion without alarms and cracks may allow cleaning fluids to damage hardware.
Product
CME America T-Syringe Pump - Neofeed - 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-0498-2021·2020-12-09
Olympus Ultrasound Endoscope Recall for Infection Risk Mitigation
Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.
Product
Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2021·2020-12-09
Canon Flat Panel Monitor Recall Due to Cable Breakage Risk
Canon Medical System is recalling 14 CAS-930A Flat Panel Monitors because the cable may break during procedures, potentially causing delays or vessel damage.
Product
CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography…
Category
Medical Device
Distribution
Distributed nationwide
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
ModerateFDA (Devices)·Z-0509-2021·2020-12-09
B. Braun Introcan Safety IV Catheters Recalled for Missing 510(k) Clearance
Janus Trade Group is recalling B. Braun Introcan Safety IV Catheters distributed in the US without required FDA 510(k) clearance.
Product
B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0515-2021·2020-12-09
Capnostream 35 Portable Respiratory Monitor Recalled for False Temperature Display
Covidien LLC is recalling 3,217 Capnostream 35 Portable Respiratory Monitors because they may display a false 'Temperature Exceeds Limits' message and shut down without an alarm.
Product
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0511-2021·2020-12-09
ICU Medical Recalls IV Administration Sets with Incorrect Filter Assemblies
ICU Medical is recalling 1,100 units of smallbore IV administration sets due to incorrect filter assemblies. The products were distributed nationwide.
Product
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0533-2021·2020-12-09
Ethicon Recalls PROCEED Surgical Mesh Due to Foreign Material in Packaging
Ethicon is recalling 15 units of PROCEED Surgical Mesh because a hair was found inside the primary packaging of a sterile device.
Product
PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0522-2021·2020-12-09
Chromsystems Recalls MassChrom Cortisol Saliva Control Level I Vials
Chromsystems is recalling 880 vials of MassChrom Cortisol, Cortisone Saliva Control Level I because the control lots may not meet stability criteria, potentially causing increased patient results.
Product
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0519-2021·2020-12-09
Bausch & Lomb Recalls Toric Intraocular Lenses Due to Missing Axis Marks
Bausch & Lomb is recalling 31 MX60ET toric intraocular lenses because they may be missing toric axis marks, which are necessary for proper surgical placement.
Product
MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0524-2021·2020-12-09
ROi CPS Recalls Labor and Delivery Kits Due to Labeling Error
ROi CPS LLC is recalling 220 labor and delivery kits because of an incorrect expiration date on the label.
Product
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0508-2021·2020-12-09
BD Ultra-Fine Pen Needles Recalled for Incorrect US Labeling
Becton Dickinson is recalling 2.8 million BD Ultra-Fine Pen Needles because US cartons are missing specific compatibility information.
Product
BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0521-2021·2020-12-09
Chromsystems Saliva Calibrator Set Recalled for Stability Issues
Chromsystems is recalling 6PLUS1 Multilevel Saliva Calibrator Sets because they may not meet stability criteria, potentially causing increased cortisone results in patient samples.
Product
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0523-2021·2020-12-09
Chromsystems Recalls MassChrom Cortisol and Cortisone Saliva Control Level II Kits
Chromsystems is recalling MassChrom Cortisol, Cortisone Saliva Control Level II kits because control lots may not meet stability criteria, potentially causing increased results for patient cortisone samples.
Product
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Category
Medical Device
Distribution
Distributed nationwide
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

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15851–15875 of 40287