💊 Drugs Class I - Dangerous
GMP Deviations
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.
🏥 Medical Devices Class I - Dangerous
FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
VNS Therapy¿ AspireSR¿ Generator
LivaNova USA
🏥 Medical Devices Class I - Dangerous
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
CEI Cutting Edge Instruments (PTC-57C)
Coltene Whaledent
🏥 Medical Devices Class I - Dangerous
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Osteosynthesis Compression Staple EasyClip
Stryker GmbH
🏥 Medical Devices Class I - Dangerous
The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
FG 57 100057X (100057X)
Coltene Whaledent
🏥 Medical Devices Class I - Dangerous
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Class IV New Era medical laser device
Inova Lasers
🏥 Medical Devices Class I - Dangerous
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
🏥 Medical Devices Class I - Dangerous
The product may be mislabeled.
Alpen Clinic 100 Carbide Instruments (R100057C)
Coltene Whaledent
🏥 Medical Devices Class I - Dangerous
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
v|tome|x L Series non-destructive testing cabinet x-ray systems
Ge Inspection Technologies
🏥 Medical Devices Class I - Dangerous
It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide "Audible and visible warning signals within the cabinet" if the "warm up" mode was not completed after initializing the system when first turned on.
Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
The feeding spike sets may leak at the interface of the tube and spike connector.
🏥 Medical Devices Class I - Dangerous
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
🏥 Medical Devices Class I - Dangerous
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
🏥 Medical Devices Class I - Dangerous
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.
Clinic Pack 100 Pieces FG 57 100057C (100057C)
Coltene Whaledent
🏥 Medical Devices Class I - Dangerous
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.
Cardinal Health 200
🏥 Medical Devices Class I - Dangerous
The feeding spike sets may leak at the interface of the tube and spike connector.
🏥 Medical Devices Class I - Dangerous
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
🏥 Medical Devices Class I - Dangerous
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
🏥 Medical Devices Class I - Dangerous
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.