Prismaflex System, Prismaflex Control Unit
Baxter Healthcare
Class I - Dangerous
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Radiometer Medical ApS
Class I - Dangerous
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
CapsoCAM Plus, UDI: 00867770000209
Capso Vision
Class I - Dangerous
Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare
Class I - Dangerous
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
ClearCanvas RIS/PACS
Synaptive Medical
Class I - Dangerous
A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Olympus Pleuravideoscope, Model LTF-160
Olympus Corporation of the Americas
Class I - Dangerous
There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
Boston Scientific
Class I - Dangerous
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Carolina Liquid Chemistries
Class I - Dangerous
Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Radiometer Medical ApS
Class I - Dangerous
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Boston Scientific
Class I - Dangerous
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Radiometer Medical ApS
Class I - Dangerous
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.
Class I - Dangerous
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach.
Class I - Dangerous
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR
Fresenius Medical Care Holdings
Class I - Dangerous
A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Abbott Gmbh & Co. KG
Class I - Dangerous
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
Boston Scientific
Class I - Dangerous
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.
Rayner Intraocular Lenses Limited
Class I - Dangerous
RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.
Class I - Dangerous
There was a potential that a 25-gauge infusion cannula may be included within the procedure pak instead of a 20-gauge infusion cannula.