Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 1,801–1,850 of 8,689
- Class II
Medical Device Recall · January 16, 2026
Integra LifeSciences Corp. (NeuroSciences)
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healPotential packaging failures, which could lead to a breach in the sterile barrier.
- Class I
Medical Device Recall · January 16, 2026
Olympus Corporation of the Americas
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatmeIssue with software algorithm which may lead to overpressure events.
- Class II
Medical Device Recall · January 15, 2026
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM ComponenThere is the potential for the length of the trocar shaft to be too long.
- Class II
Medical Device Recall · January 15, 2026
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036Knee and Humeral socket implants contain incorrect labeling.
- Class II
Medical Device Recall · January 15, 2026
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707Knee and Humeral socket implants contain incorrect labeling.
- Class II
Medical Device Recall · January 15, 2026
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
- Class II
Medical Device Recall · January 15, 2026
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432Knee and Humeral socket implants contain incorrect labeling.
- Class II
Medical Device Recall · January 15, 2026
Custom Interventional Pain Management, LLC
Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continDue to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
- Class II
- Class II
- Class II
Medical Device Recall · January 13, 2026
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/APumps were released without full testing being performed, including occlusion alarm testing.
- Class II
Medical Device Recall · January 13, 2026
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Class II
Medical Device Recall · January 13, 2026
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 8811units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-2835/12;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-2836/11;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/15;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/12;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/11;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/16;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-0027/11;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/09;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8030/12;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 12, 2026
Waldemar Link GmbH & Co. KG (Mfg Site)
Endo-Model Replacement Plateau; Item Number: 15-8521/15;The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
- Class II
Medical Device Recall · January 9, 2026
FUJIFILM Healthcare Americas Corporation
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
- Class II
Medical Device Recall · January 9, 2026
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
- Class II
Medical Device Recall · January 9, 2026
Technological Medical Advancements LLC
Diowave Laser System, REF: Diowave 250WSoftware update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
- Class II
Medical Device Recall · January 9, 2026
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used forMix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
- Class II
Medical Device Recall · January 9, 2026
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used forMix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
- Class II
Medical Device Recall · January 8, 2026
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 Medline CENTRAL LINE INSERTION SKU DYNJ63347AAffected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- Class II
Medical Device Recall · January 8, 2026
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- Class II
Medical Device Recall · January 8, 2026
Olympus Corporation of the Americas
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G ProductMis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
- Class II
Medical Device Recall · January 8, 2026
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- Class II
Medical Device Recall · January 8, 2026
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- Class II
Medical Device Recall · January 8, 2026
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALYSISAffected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- Class II
Medical Device Recall · January 8, 2026
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SAffected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPARMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDSMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200AMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Olympus Corporation of the Americas
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be usDevices which did not undergo thermoforming could deform and lose performance.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945PMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Olympus Corporation of the Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire fDevices which did not undergo thermoforming could deform and lose performance.
- Class II
Medical Device Recall · January 7, 2026
Olympus Corporation of the Americas
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire fDevices which did not undergo thermoforming could deform and lose performance.
- Class II
Medical Device Recall · January 7, 2026
Olympus Corporation of the Americas
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designedDevices which did not undergo thermoforming could deform and lose performance.
- Class II
Medical Device Recall · January 7, 2026
Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2) GOWN,SIRUS,NONRNF,SETINSLV,L,20/CS, Model Number: DYNJP2001S; 3) GOWN,ECLIPSE,NONRNF,XL,ST,30/CS, Model Number: DYNJP20Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
- Class II
Medical Device Recall · January 7, 2026
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINALMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.