🔍 RecallPedia

All Recalls

95,018 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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9,571
Consumer Products

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.

Fresenius Medical Care Holdings

🏥 Medical Devices Class I - Dangerous

Exposed to freezing temperatures due to refrigerated truck malfunctions

Apr 28, 2021 Infusion Pumps View Details →

SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.

Soft Computer Consultants

🏥 Medical Devices Class I - Dangerous

Software showing wrong results reported, PDF not match HIS.

Mar 31, 2021 Diagnostic Equipment View Details →

Medtronic Reveal LINQ LNQ11 / PA96000

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

🏥 Medical Devices Class I - Dangerous

Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.

Jun 1, 2021 Other Medical Devices View Details →

Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

Cardinal Health 200

🏥 Medical Devices Class I - Dangerous

A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.

Jun 9, 2021 Infusion Pumps Nationwide View Details →

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.

Exactech

🏥 Medical Devices Class I - Dangerous

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

Jun 29, 2021 Implants & Prosthetics Nationwide View Details →

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized, 28mm; and Novation GXL Liner, +5mm Lateralized, G0, 22mm ID. Orthopedic hip implant component.

Exactech

🏥 Medical Devices Class I - Dangerous

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

Jun 29, 2021 Implants & Prosthetics Nationwide View Details →

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.

Exactech

🏥 Medical Devices Class I - Dangerous

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

Jun 29, 2021 Implants & Prosthetics Nationwide View Details →

Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

Respironics California

🏥 Medical Devices Class I - Dangerous

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

Jun 18, 2021 Patient Monitors Nationwide View Details →