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

17701–17725 of 27534

CriticalFDA (Devices)·Z-2251-2018·2018-06-27
Draeger Fabius GS Tiro Anesthesia Machine Recalled for Hypoxia Risk
Draeger Medical is recalling 31 Fabius GS Tiro anesthesia machines because a fault could allow 100% nitrous oxide delivery, creating a risk of hypoxic mixtures and patient death.
Product
Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders.…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2252-2018·2018-06-27
Draeger Fabius GS MRI Anesthesia Machine Recalled for Hypoxia Risk
Draeger Medical is recalling four Fabius GS MRI Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, potentially causing death.
Product
Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders.…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2250-2018·2018-06-27
Draeger Fabius GS Premium Anesthesia Machine Recalled for Hypoxia Risk
Draeger Medical is recalling 62 Fabius GS Premium Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.
Product
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2238-2018·2018-06-27
Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 11 trauma guide wires due to packaging defects that may compromise sterility, posing an infection risk.
Product
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2234-2018·2018-06-27
Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 449 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
Product
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2269-2018·2018-06-27
Olympus JF-140F Duodenoscopes Recalled for New Reprocessing Procedures
Olympus is recalling 994 JF-140F duodenoscopes nationwide to implement new reprocessing procedures following reported patient infections.
Product
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2271-2018·2018-06-27
CryoLife Recalls Cryovalve SG Pulmonary Human Heart Valve
CryoLife, Inc. is recalling one unit of the Cryovalve SG Pulmonary Human Heart Valve because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.
Product
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2254-2018·2018-06-27
Draeger Perseus A500 Anesthesia Machine Recalled for Hypoxic Mixture Risk
Draeger Medical is recalling 33 Perseus A500 anesthesia machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.
Product
Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2018·2018-06-27
Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 2,396 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
Product
3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2235-2018·2018-06-27
Zimmer Biomet Recalls Ball Tip Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 26 units of Ball Tip Guide Wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
Product
BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2018·2018-06-27
Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, creating a risk of infection.
Product
BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2272-2018·2018-06-27
CryoLife Pulmonary Cardiac Branch Recalled Due to Morphine Presence
CryoLife, Inc. is recalling one unit of Cryopatch SG Pulmonary Human Cardiac Branch because final autopsy and toxicology reports indicated the presence of morphine in the donor's urine.
Product
Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2263-2018·2018-06-27
TriMed Nitinol Staples Recalled Due to Missing Sterilization Audit Records
TriMed Inc. is recalling 323 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.
Product
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2245-2018·2018-06-27
Synthes Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set Recalled
Synthes (USA) Products LLC is recalling 7 units of a combined cannulated screw set because the included gauges measure screws 5.41mm shorter than actual length.
Product
Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2249-2018·2018-06-27
Vascular Solutions Recalls Drainer Centesis Catheters Due to Bacterial Endotoxins
Vascular Solutions, Inc. is recalling specific lots of Drainer Centesis Catheters because the supplier reported a potential for unsafe levels of bacterial endotoxins.
Product
Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2256-2018·2018-06-27
Pentax C2 CryoBalloon Focal Catheter Recalled for Connector Alignment Defect
Pentax of America Inc is recalling 57 units of the C2 CryoBalloon Focal Catheter because a misaligned arrow may allow the catheter to detach from the controller during use.
Product
C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2247-2018·2018-06-27
Synthes Graphic Case F/7.3mm Cannulated Screw Set Recalled for Measurement Error
Synthes (USA) Products LLC is recalling three units of the Graphic Case F/7.3mm Cannulated Screw Set because the included gauges measure screws 5.41mm shorter than their actual length.
Product
Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2248-2018·2018-06-27
Siemens Biograph mCT Systems Recalled Due to Falling Laser Cover Windows
Siemens Medical Solutions is recalling 405 Biograph mCT systems because laser cover windows may fall off, posing a potential hazard.
Product
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2246-2018·2018-06-27
Synthes Graphic Case F/6.5mm Cannulated Screw Set Recalled for Measurement Error
Synthes (USA) Products LLC is recalling four units of the Graphic Case F/6.5mm Cannulated Screw Set because the screw gauges measure 5.41mm shorter than the actual screw length.
Product
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2262-2018·2018-06-27
TriMed Recalls Nitinol Staples Due to Missing Sterilization Audit Records
TriMed Inc. is recalling 532 Nitinol staples because quarterly sterilization dose audit records could not be found, posing a risk of patient infection.
Product
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2266-2018·2018-06-27
Datex-Ohmeda CARESCAPE R860 Ventilators Recalled for Display Processor Failure
Datex-Ohmeda is recalling CARESCAPE R860 ventilators with software version 10SP05 because the display processor may experience unexpected failure.
Product
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2231-2018·2018-06-27
Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
Product
DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2233-2018·2018-06-27
Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling specific trauma guide wires because packaging defects may allow sterile barrier breaches, creating a potential risk of infection.
Product
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2265-2018·2018-06-27
TriMed Nitinol Staple Recall Due to Missing Sterilization Audit Records
TriMed Inc. is recalling 1,194 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.
Product
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2237-2018·2018-06-27
Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 832 trauma guide wires because packaging defects may compromise sterility, posing a risk of infection.
Product
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Category
Medical Device
Distribution
Distributed nationwide

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17701–17725 of 27534