🔍 RecallPedia

All Recalls

95,075 total recalls in our database

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28,983
Food
 💊
17,685
Drugs
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38,779
Medical Devices
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9,628
Consumer Products

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.

Fresenius Medical Care Renal Therapies Group

🏥 Medical Devices Class I - Dangerous

The bottles are mislabeled with an incorrect part number.

May 2, 2018 Other Medical Devices Nationwide View Details →

ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia

Tosoh Bioscience

🏥 Medical Devices Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.

Baxter Healthcare

🏥 Medical Devices Class I - Dangerous

The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.

May 8, 2018 Diagnostic Equipment Nationwide View Details →

ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid

Tosoh Bioscience

🏥 Medical Devices Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →

Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.

CareFusion 303

🏥 Medical Devices Class I - Dangerous

Reports of incorrect priming volume due to manufacturing with incorrect tubing.

Nov 6, 2017 Surgical Instruments View Details →

Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications.

Draeger Medical Systems

🏥 Medical Devices Class I - Dangerous

Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement

May 15, 2018 Diagnostic Equipment Nationwide View Details →