🏥 Medical Devices Class I - Dangerous
Reports of unexpected movement.
All Recalls
95,114 total recalls in our database
Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.
16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
The Anspach Effort
🏥 Medical Devices Class I - Dangerous
Customer complaint indicating the color bands on the MIA16-G1 were not correct.
The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical
🏥 Medical Devices Class I - Dangerous
The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.
🏥 Medical Devices Class I - Dangerous
This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product.
🏥 Medical Devices Class I - Dangerous
Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.
🏥 Medical Devices Class I - Dangerous
Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.
🏥 Medical Devices Class I - Dangerous
Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.
🏥 Medical Devices Class I - Dangerous
CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
🏥 Medical Devices Class I - Dangerous
Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.
🏥 Medical Devices Class I - Dangerous
A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labeled as distal.
🏥 Medical Devices Class I - Dangerous
The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.
DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
Express Diagnostics Int'l.
🏥 Medical Devices Class I - Dangerous
This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Use of this product may give incorrect screening results.
🏥 Medical Devices Class I - Dangerous
A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001. A continuous real-time monitor for non-invasive hematocrit, oxygen saturation and percent change in blood volume calculation during hemodialysis treatment.
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
Potential for misinterpretation of the graphic display of the Blood Volume ( BV) slope
Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to tighten and loosen the grip of the pole clamp to the pole.
🏥 Medical Devices Class I - Dangerous
Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
SCC Soft Computer
🏥 Medical Devices Class I - Dangerous
The interface fails to send abnormal flags for Reference Lab test results.