🏥 Medical Devices Class I - Dangerous
Label does not state that the product is heparin-coated.
All Recalls
95,075 total recalls in our database
CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
🏥 Medical Devices Class I - Dangerous
One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
🏥 Medical Devices Class I - Dangerous
Contact lenses lack sterility assurance.
🏥 Medical Devices Class I - Dangerous
All patient serum samples yield a weakly positive test result.
Accolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
Inner and outer sterile barriers not fully sealed.
INFINITY DUAL HEMO MCable Pod
Draegar Medical Systems
🏥 Medical Devices Class I - Dangerous
Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
🏥 Medical Devices Class I - Dangerous
Contact lenses lack sterility assurance.
🏥 Medical Devices Class I - Dangerous
Contact lenses lack sterility assurance.
🏥 Medical Devices Class I - Dangerous
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness.
NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
Zimmer Biomet
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
T/Pump temperature therapy pump, Models TP700 and TP700C
Stryker Medical Division of Stryker
🏥 Medical Devices Class I - Dangerous
The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.
🏥 Medical Devices Class I - Dangerous
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Fixed Core Bentson
Cook
🏥 Medical Devices Class I - Dangerous
Label does not state that the product is heparin-coated.
🏥 Medical Devices Class I - Dangerous
Contact lenses lack sterility assurance.