🔍 RecallPedia

All Recalls

95,089 total recalls in our database

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28,983
Food
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17,685
Drugs
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38,779
Medical Devices
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9,642
Consumer Products

AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Endologix

🏥 Medical Devices Class I - Dangerous

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Dec 27, 2016 Implants & Prosthetics Nationwide View Details →

Fresenius 2008K@home Series : Hemodialysis System

Fresenius Medical Care Renal Therapies Group

🏥 Medical Devices Class I - Dangerous

When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine

Dec 21, 2016 Other Medical Devices Nationwide View Details →

Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.

The Binding Site Group

🏥 Medical Devices Class I - Dangerous

Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.

May 13, 2015 Diagnostic Equipment Nationwide View Details →

Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.

Medacta Usa

🏥 Medical Devices Class I - Dangerous

Damaged packaging, lack of sterility assurance

Dec 7, 2016 Other Medical Devices Nationwide View Details →

NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.

BioMerieux SA

🏥 Medical Devices Class I - Dangerous

A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.

Nov 23, 2016 Diagnostic Equipment Nationwide View Details →

Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.

Smith & Nephew

🏥 Medical Devices Class I - Dangerous

Lack of 510k clearance for design modification.

Nov 11, 2016 Infusion Pumps Nationwide View Details →

AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Endologix

🏥 Medical Devices Class I - Dangerous

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Dec 27, 2016 Implants & Prosthetics Nationwide View Details →

Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

The Binding Site Group

🏥 Medical Devices Class I - Dangerous

Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.

Jul 5, 2016 Diagnostic Equipment View Details →