🏥 Medical Devices Class I - Dangerous
Tip Breakage at the glue joint between the obturator body and tip
All Recalls
95,089 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Shipping carton labeling error.
Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Arrow International
🏥 Medical Devices Class I - Dangerous
Shipping carton labeling error.
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
🏥 Medical Devices Class I - Dangerous
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely event that the cache disk is almost full (<100MB) and HL-7 update events are received, the update action fails and an empty path name is written to the EA database. As a result the instance is not deleted from the storage device but no longer referenced. When trying to retrieve the instance an error is returned.
ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
🏥 Medical Devices Class I - Dangerous
ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the patient or the caregiver. The tipping phenomenon has been found during internal device testing. To date, there have been no adverse events or customer complaints related to the tipping phenomenon. The tipping hazard may occur when fully loaded Sara Combilizer in "stretcher mode" is lifted to the highest position (approximately 984 mm = 38 3/4") and tilted backwards to the angle of 25 degrees¿-28 degrees¿. Although such scenario has been defined as highly unlikely to occur during use with patients, as a commitment to quality, ArjoHuntleigh is providing customers with information on action needed. The Sara Combilizer may stay in use until the upgrade will be performed, on the condition that the tilt angle in the device ''stretcher mode" will be no greater than minus 15 degrees¿ and the device is not loaded over 330 lbs (150 kg).
🏥 Medical Devices Class I - Dangerous
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
🏥 Medical Devices Class I - Dangerous
The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. The replacement is intended to prevent risk of electric shock.
BrightView XCT Upgrade Model 882454
Philips Medical Systems (Cleveland)
🏥 Medical Devices Class I - Dangerous
The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. The issue was caused by a software defect in the workflow setup script.
🏥 Medical Devices Class I - Dangerous
🏥 Medical Devices Class I - Dangerous
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
🏥 Medical Devices Class I - Dangerous
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
🏥 Medical Devices Class I - Dangerous
Certain lots of the acid solution in Acecide-C are degrading faster than normal.
🏥 Medical Devices Class I - Dangerous
The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Integra LifeSciences Corp. d.b.a. Integra Pain Management
🏥 Medical Devices Class I - Dangerous
Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.
🏥 Medical Devices Class I - Dangerous
There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.
e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
"We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. The purpose of this letter is to remind users of the patient positioning instructions for your e.cam or Symbia E system and to inform you of an update that will be performed by your local Siemens service representative."