🏥 Medical Devices Class I - Dangerous
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
All Recalls
95,114 total recalls in our database
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
🏥 Medical Devices Class I - Dangerous
On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.
🏥 Medical Devices Class I - Dangerous
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
🏥 Medical Devices Class I - Dangerous
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
🏥 Medical Devices Class I - Dangerous
Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. This could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
🏥 Medical Devices Class I - Dangerous
incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence
🏥 Medical Devices Class I - Dangerous
A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips results may be biased by up to +/-16% for both immunometric and competitive assays.
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Silk Road Medical
🏥 Medical Devices Class I - Dangerous
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
🏥 Medical Devices Class I - Dangerous
Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
Infusion Pump
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
Battery performance issues related to prolonged storage.
🏥 Medical Devices Class I - Dangerous
Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
Model Year 2017-2020 Masi Evoluzione and Gran Corsa bicycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The bicycle's fork steerer tube can break, causing the rider to lose control, fall and suffer injuries.
Imatinib Mesylate Tablets 100 mg, Imatinib Mesylate Tablets 400 mg, Pregabalin Capsules 50 mg, Pregabalin Capsules 75 mg, Pregabalin Capsules 100 mg, Pregabalin Capsules 150 mg, Sevelamer Carbonate Tablets 800 mg, Tadalafil Tablets 5 mg and Tadalafil Tablets 20 mg
Dr. Reddy's Laboratories, Ltd., of India
🏠 Consumer Products Class II - Moderate
The products are prescription medications that were labeled and distributed by Dr. Reddy's for institutional use only. The prescription medications were distributed by third party wholesalers to retail pharmacies and could have been dispensed to consumers. The packaging of the products is not child resistant and can pose a risk of poisoning if the contents are swallowed by young children.
StyleWell Wood Windsor Dining Chair Sets
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The chair's back can detach, posing a fall hazard to consumers.
deSensua Wintergreen, Birch and Pain Soother Essential Oils
MTIG Productions LLC
🏠 Consumer Products Class II - Moderate
The products contain the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
🍎 Food Class I - Dangerous
Ingredients were not pasteurized after blending as required by State of Wisconsin.
🍎 Food Class I - Dangerous
Ingredients were not pasteurized after blending as required by State of Wisconsin.