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

23351–23375 of 40299

ModerateFDA (Devices)·Z-2315-2018·2018-07-04
Toshiba Diagnostic Ultrasound Systems Recalled for Power Supply Defect
Toshiba is recalling 162 Aplio I-series diagnostic ultrasound systems because the power supply unit may be damaged and fail to start up.
Product
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2309-2018·2018-07-04
Siemens Artis zee Biplane MN Recalled for Display Failure
Siemens is recalling two Artis zee biplane MN systems because the large display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.
Product
Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2279-2018·2018-07-04
Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues
Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 2 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
Product
Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2286-2018·2018-07-04
Horiba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation
Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because they may produce elevated results if used immediately after a specific creatinine reagent.
Product
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2319-2018·2018-07-04
St Jude Medical Recalls Ellipse ICDs for Security Firmware Update
St Jude Medical is recalling Ellipse ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
Product
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2278-2018·2018-07-04
Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues
Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 1 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
Product
Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2331-2018·2018-07-04
BioMerieux Recalls VIDAS FSH Assay Kits Due to Calibration Issues
BioMerieux SA is recalling VIDAS FSH assay kits due to invalid calibration errors. The recall affects 59 units distributed in the U.S.
Product
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2321-2018·2018-07-04
St Jude Medical Recalls Fortify Assura ICDs for Security Firmware Update
St Jude Medical is recalling Fortify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Product
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2326-2018·2018-07-04
St Jude Medical Recalls Unify ICDs for Security Firmware Update
St Jude Medical is recalling Unify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
Product
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2253-2018·2018-06-27
Draeger Apollo Anesthesia Machine Recalled for Potential Hypoxic Gas Delivery
Draeger Medical is recalling 72 Apollo Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, posing a risk of death.
Product
Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration…
Category
Medical Device
Distribution
Distributed nationwide
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

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23351–23375 of 40299