The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.
All Recalls
95,038 total recalls in our database
KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Palodex Group Oy
Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.
iChem VELOCITY Urine Chemistry Analyzer
Beckman Coulter
Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.
The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Medicrea International
Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
Polymer Technology Systems
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
Paltop Advanced Dental Solutions
Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant.
Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
Medicrea International
Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Arrow International
Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.
GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.
Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.
Pillo Portable Napper
Unknown Manufacturer
Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.
Graco Little Lounger Rocking Seat
Unknown Manufacturer
Infant fatalities have been reported with other manufacturers' inclined sleep products, after infants rolled from their back to their stomach or side, or under other circumstances.
SwaddleMe By Your Bed Sleeper inclined sleeper
Unknown Manufacturer
Infant fatalities have been reported with other manufacturers' inclined sleep products, after the infants rolled from their back to their stomach or side, or under other circumstances.
Spare 10,000 mAh Power Banks
Unknown Manufacturer
The power bank's lithium-ion battery can overheat and ignite, posing fire and burn hazards.
STIHL RE 90 Pressure Washers
Unknown Manufacturer
The pressure washer nozzle can disconnect from the spray wand when under pressure during use, posing an injury hazard.
Stand2Learn Stools
Unknown Manufacturer
The foot support on the stool was improperly welded and can break, posing a fall hazard to consumers.
Dierbergs Kitchen Remoulade packaged in 12 OZ containers, UPC 2393330149 and 24616200000
Dierbergs Markets, Inc Corporate Office
The firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were subsequently used to manufacture various salad and deli products.
Signature Crab Cake, Signature Crab Cake (2 pk), and Signature Crab Cake (4pk); Wegmans Ready to Cook Signature Crab Cake; Oven ready tray; various sizes, keep Refrigerated or Frozen
Wegmans Food Markets
Products contain undeclared soy.