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

29676–29700 of 40325

HighFDA (Devices)·Z-2135-2016·2016-07-13
Toshiba Vantage Titan 3T MRI System Recalled for Gradient Coil Issue
Toshiba American Medical Systems is recalling 33 Vantage Titan 3T MRI systems due to a potential problem with the gradient coil.
Product
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2016·2016-07-13
Custom Ultrasonics System 83 Plus Endoscope Washer Recall Issued
Custom Ultrasonics is recalling System 83 Plus endoscope washer/disinfectors to warn customers not to use them for duodenoscopes until further notice.
Product
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2016·2016-07-13
Medtronic Recalls Cytosponge Cell Collection Device Due to Detachment Reports
Medtronic is recalling the Cytosponge Cell Collection Device after two reports of the device detaching from its removal string during withdrawal from the esophagus.
Product
Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2125-2016·2016-07-13
Medtronic Recalls MyCareLink Patient Monitor Due to Data Transmission Failure
Medtronic is recalling 262 MyCareLink Patient Monitors because a software update prevents implanted device data from reaching clinicians, despite appearing successful to patients.
Product
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2126-2016·2016-07-13
Anspach Effort Recalls Battery Oscillators with Incorrect Mode Switch Labels
The Anspach Effort, Inc. is recalling 20 Battery Power Line II Battery Oscillators because the mode switch ring has incorrect operating directions.
Product
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2133-2016·2016-07-13
Cadillac First Aid Kit Recalled for Prescription-Only CPR Mask
Lifeline First Aid LLC is recalling Cadillac First Aid Kits because they contain a CPR mask cleared only for prescription use, not over-the-counter.
Product
5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-2136-2016·2016-07-13
Arrow Recalls Central Venous Catheters Due to Length Mismatch
Arrow International Inc. is recalling specific lots of central venous catheters because kits labeled for 20 cm catheters may contain 16 cm catheters.
Product
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. Product Usage: Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2137-2016·2016-07-13
Ergoactives Recalls HeaterBaum Foot and Ankle Heating Pads
Ergoactives is recalling 278 HeaterBaum Foot & Ankle Heating Pads because they were marketed without a cleared 510(k).
Product
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC Adapter.
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-2004-2016·2016-07-13
Musculoskeletal Transplant Foundation Recalls AFT Diverted Tubes Due to Unsealed Pouch
Musculoskeletal Transplant Foundation is recalling 114 AFT Diverted Tubes because an unsealed Tyvek pouch could introduce contamination into the sterile field.
Product
Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2132-2016·2016-07-13
Lifeline CPR Rescue Kits Recalled for Prescription-Only Mask Component
Lifeline First Aid LLC is recalling CPR rescue kits because the included CPR shield mask is cleared only for prescription use, not over-the-counter.
Product
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red…
Category
Medical Device
Distribution
23 states
ModerateFDA (Devices)·Z-2120-2016·2016-07-13
ZYTO Technologies Recalls ZYTO Tower and Software for Regulatory Violations
ZYTO Technologies is voluntarily recalling ZYTO Tower devices and software because their marketing claims exceeded the scope of their FDA 510(k) clearance.
Product
The ZYTO Tower is the input device to program the software with various virtual items.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2138-2016·2016-07-13
Synthes Ti Button Plate Recalled for Inaccurate MR Safety Labeling
Synthes (USA) Products LLC is recalling 6,255 Ti Button Plate units because their MR safety information does not meet current ASTM standards.
Product
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Category
Medical Device
Distribution
50 states
ModerateFDA (Devices)·Z-2083-2016·2016-07-13
Medtronic Navigation O-arm 02 surgical x-ray system recalled for labeling gaps
Medtronic Navigation is recalling 63 O-arm 02 surgical x-ray imaging systems nationwide due to gaps in electronic product labeling and Instructions for Use compliance.
Product
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2121-2016·2016-07-13
ZYTO Software Recalled for Exceeding 510(k) Clearance Claims
ZYTO Technologies is voluntarily recalling ZYTO Tower and software programs because their claims exceeded the scope of their FDA 510(k) clearance.
Product
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2128-2016·2016-07-13
Exactech Recalls Novation Hip Stems Due to Incorrect GTIN Labeling
Exactech is recalling 14 Novation femoral stems because they were labeled with an incorrect Global Trade Item Number (GTIN). The error identifies the devices as a different product.
Product
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2119-2016·2016-07-13
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Calibrator Kit 29
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 29 because incorrect calibration mathematics may cause biased test results for total iron-binding capacity.
Product
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2127-2016·2016-07-13
Exactech Recalls Hip Replacement Stems Due to Incorrect GTIN Labeling
Exactech is recalling 8 units of Novation Press-Fit Splined Femoral Stems because they are labeled with an incorrect Global Trade Item Number (GTIN).
Product
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2100-2016·2016-07-06
Physio-Control Recalls LIFEPAK AEDs Due to Shock Delivery Failure Risk
Physio-Control is recalling LIFEPAK CR Plus and EXPRESS AEDs because a faulty component may prevent the device from delivering a shock during cardiac arrest.
Product
LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2113-2016·2016-07-06
Philips Ingenuity Flex MRI Units Recalled for Cracking Cover Hazard
Philips is recalling 10 Ingenuity Flex MRI units because a thinner plastic cover may crack, posing an injury risk to patients and staff.
Product
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2114-2016·2016-07-06
Philips Ingenuity Core 128 MRI Systems Recalled for Cover Crack Risk
Philips is recalling 14 Ingenuity Core 128 MRI systems because a thinner plastic cover may crack, posing an injury risk to patients and staff.
Product
Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2060-2016·2016-07-06
Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage
Hospira is recalling PlumSet IV administration sets because intravenous fluid may leak at the secondary port. The recall covers 3,920,932 units distributed in the US and Canada.
Product
*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2064-2016·2016-07-06
CareFusion Alaris System PC Unit Recall for Incorrect Patient Weight Data
CareFusion 303, Inc. is recalling 69,693 Alaris System PC Units because the RESTORE feature may incorrectly populate patient weight for specific infusion modules.
Product
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2052-2016·2016-07-06
Elekta MOSAIQ Oncology System Recalled for Potential Plan Selection Error
Elekta is recalling 69 MOSAIQ Oncology Information System units because scrolling the mouse wheel could accidentally change the selected treatment plan.
Product
MOSAIQ Oncology Information System
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-2053-2016·2016-07-06
Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling 11,208 cartons of Sodium Chloride Inhalation Solution because internal dye tests failed to confirm vial integrity.
Product
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is…
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-2056-2016·2016-07-06
Hospira Symbiq Infusion Pumps Recalled for False Occlusion Alarms
Hospira is recalling Symbiq Two Channel Infusers due to frequent false occlusion alarms that may delay or interrupt patient therapy.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
Category
Medical Device
Distribution
Distributed nationwide

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29676–29700 of 40325