November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or prev
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
Biomet, Inc. recalls Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previ
Hazard: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resus
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex A
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include:
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1.
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include:
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
SunMed Holdings, LLC recalls Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include
Hazard: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
November 29, 2023Medical DevicesFDA
Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on me
Hazard: Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
November 29, 2023Medical DevicesFDA
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00
Hazard: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
November 29, 2023Medical DevicesFDA
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500
Hazard: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
November 29, 2023Medical DevicesFDA
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Hazard: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
November 29, 2023Medical DevicesFDA
Sage Products Inc recalls stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Hazard: A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label
November 29, 2023Medical DevicesFDA
Medtronic Neuromodulation recalls Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Hazard: Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
November 29, 2023Medical DevicesFDA
BioFire Diagnostics, LLC recalls FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen
Hazard: Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess heating inside of the power switch, subsequently leading to deformation of the power switch case. The deformation can create an opportunity for a power switch electrical short. In addition to an electrical short, deformation may result in an open circuit causing the power switch to fail. This event would only occur after the product is in use.
November 29, 2023Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31
Hazard: Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
November 29, 2023Medical DevicesFDA
Becton Dickinson & Company recalls BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bond
Hazard: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
November 29, 2023Medical DevicesFDA
Becton Dickinson & Company recalls BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW AB
Hazard: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
November 29, 2023Medical DevicesFDA
Becton Dickinson & Company recalls BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore
Hazard: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, U
Hazard: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and
Hazard: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and en
Hazard: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic proced
Hazard: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-
Hazard: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophag
Hazard: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum an
Hazard: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection