Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-06-12FDA-DeviceOriGen Biomedical, Inc.Class IECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
- 2019-06-12FDA-DeviceOriGen Biomedical, Inc.Class IECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
- 2019-06-05FDA-DeviceNeuroLogica CorporationClass IISamsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
- 2019-06-05FDA-DeviceExactech, Inc.Class IIOpteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
- 2019-06-05FDA-DeviceExactech, Inc.Class IIOpteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
- 2019-06-05FDA-DeviceExactech, Inc.Class IIOpteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
- 2019-06-05FDA-DeviceAbbott VascularClass IIAbbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.
- 2019-06-05FDA-DeviceTeleflex MedicalClass IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- 2019-06-05FDA-DeviceTeleflex MedicalClass IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- 2019-06-05FDA-DeviceTeleflex MedicalClass IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- 2019-06-05FDA-DeviceTeleflex MedicalClass IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- 2019-06-05FDA-DeviceTeleflex MedicalClass IIRUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
The firm received reports indicating that the laser guard foil partially separated and/or slightly detached at the edges.
- 2019-06-05FDA-DeviceKing Systems Corp. dba Ambu, Inc.Class IIKing LTS-D Kit Size 1, Model Number KLTSD431
Size 0 products were incorrectly packaged and labeled as a size 1 products.
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- 2019-06-05FDA-DeviceMaquet Cardiovascular, LLCClass IIMaquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
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