RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Cardinal Health
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
All Recalls
95,025 total recalls in our database
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
🏥 Medical Devices Class I - Dangerous
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
🏥 Medical Devices Class I - Dangerous
Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Cardinal Health
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Major Vascular CDS Convenience Kit
Medline Industries
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010
Cardinal Health
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
🏥 Medical Devices Class I - Dangerous
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
🏥 Medical Devices Class I - Dangerous
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Bedside PICC CDS Convenience Kit
Medline Industries
🏥 Medical Devices Class I - Dangerous
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Xstrahl Limited
🏥 Medical Devices Class I - Dangerous
Base plate may detach from the main body of the treatment applicator.
🏥 Medical Devices Class I - Dangerous
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
🏥 Medical Devices Class I - Dangerous
Potential for open packaging seals compromising the sterility of the surgical gowns
🏥 Medical Devices Class I - Dangerous
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
🏥 Medical Devices Class I - Dangerous
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Ossur Americas
🏥 Medical Devices Class I - Dangerous
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
🏥 Medical Devices Class I - Dangerous
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."