Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
-
Class II · 12 months ago
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS recall: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be…
-
Class II · 12 months ago
B-K Medical A/S Ultrasound System 1300, bkSpecto w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
-
Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
-
Class I · 12 months ago
Integra LifeSciences Corp. Codman Disposable Perforator 11mm. Cranial Perforator recall: Expansion of recall of size 14 mm Codman Disposable Perforators
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an…
-
Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
-
Class II · 12 months ago
Prismatik Dentalcraft, Inc. Brand Name: Inclusive Product Name: Inclusive Titanium recall: Incorrect titanium screw, packaged with dental implant
Incorrect titanium screw, packaged with dental implant.
-
Class II · 12 months ago
CareFusion 303, Inc. Various models of BD Pyxis Medbank: Reference numbers: 1137-00 recall: Potential fluid ingress of anesthesia station or med station may result
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
-
Class II · 12 months ago
CareFusion 303, Inc. All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 recall: Potential fluid ingress of anesthesia station or med station may result
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
-
Class II · 12 months ago
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices recall: Due to incomplete seals in the pouch which provide the sterile barrier
Due to incomplete seals in the pouch which provide the sterile barrier.
-
Class II · 12 months ago
Daye Refill 18 Coated Regular and 18 Coated Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
-
Class II · 12 months ago
Daye 9 Coated Regular Tampons and 9 Nude Regular Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
-
Class II · 12 months ago
Daye Initiation 18 Coated Super and 18 Nude Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
-
Class II · 12 months ago
Brand Name: Aesculap Product Name: Sealing Unit FOR 10/12MM Trocars recall: It was determined there is the potential of silicone fragments detaching
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
-
Class II · 12 months ago
Brand Name: Aesculap Product Name: Sealing CAP FOR 10/12MM Trocars recall: It was determined there is the potential of silicone fragments detaching
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
-
Class II · 12 months ago
Daye 9 Coated Regular and 9 Coated Super Tampons recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
-
Class II · 12 months ago
Daye All in One Bundle recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.
-
Class II · 12 months ago
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
-
Class II · 12 months ago
Endomagnetics Ltd Magseed Pro 7 cm soft tissue marker recall: Potential for contamination with cotton fibers
Potential for contamination with cotton fibers.
-
Class II · 12 months ago
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
-
Class II · 12 months ago
ICU Medical 60" Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
-
Class I · 12 months ago
IMPRIS Imaging Inc IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI recall: There is a potential safety issue associated with the magnet venting paths
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite…
-
Class II · 12 months ago
Microgenics Corporation Thermo scientific MAS Omni Cardio recall: The firm received complaints from customers reporting vial-to-vial
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This…
-
Class II · 12 months ago
ICU Medical, Inc. ChemoLock Bag Spike, 01 units REF: CL-10-10 recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
-
Class II · 12 months ago
Daye Refill 3 Month Trial Tampon Box recall: Product lacks 510(k) clearance
Product lacks 510(k) clearance.