Philips HeartStart FRx AED.
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
All Recalls
95,075 total recalls in our database
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
Madison Polymeric Engineering
🏥 Medical Devices Class I - Dangerous
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Possibility that the Biograph Horizon systems performing CT retrospective cardiac gating or PET cardiac gating examinations may experience a waveform sampling issue caused by a firmware change within the Universal Physiological Measurement Module.
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
Implant Direct Sybron Manufacturing
🏥 Medical Devices Class I - Dangerous
The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring.
🏥 Medical Devices Class I - Dangerous
The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Smith & Nephew
🏥 Medical Devices Class I - Dangerous
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
Philips HeartStart (HS1) Onsite/Home AED
Philips Electronics North America
🏥 Medical Devices Class I - Dangerous
An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
Edwards Lifesciences
🏥 Medical Devices Class I - Dangerous
Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
Madison Polymeric Engineering
🏥 Medical Devices Class I - Dangerous
The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
🏥 Medical Devices Class I - Dangerous
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
🏥 Medical Devices Class I - Dangerous
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.
🏥 Medical Devices Class I - Dangerous
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
🏥 Medical Devices Class I - Dangerous
Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates to cracking of the spring arms at the weld seams that has the potential to develop into breaks with heavy use and aging of the equipment.
🏥 Medical Devices Class I - Dangerous
Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,
🏥 Medical Devices Class I - Dangerous
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.