Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-02-07FDA-DeviceDraegerwerk Ag & Co. KgaaClass IIAtlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.
- 2024-02-07FDA-DeviceVortex Surgical Inc.Class IIVortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.
- 2024-02-07FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- 2024-02-07FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- 2024-02-07FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- 2024-02-07FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- 2024-02-07FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- 2024-02-07FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- 2024-02-07FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- 2024-02-07FDA-DevicePhilips North AmericaClass IISmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IISmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIIntera Achieva 1.5T Pulsar. Model (REF) Number 781171.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIIntera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIIntera 1.5T Achieva Nova. Model (REF) Numbers 781172.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIIngenia 3.0T CX. Model (REF) Numbers 781271, 782105.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIIngenia 1.5T CX. Model (REF) Numbers 781262, 781261.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIAchieva XR. Model (REF) Numbers 781153, 781253.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIAchieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIAchieva 1.5T Initial system. Model (REF) Numbers 781178.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIAchieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DevicePhilips North AmericaClass IIAchieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-2055
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1355
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
- 2024-02-07FDA-DeviceOlympus Corporation of the AmericasClass IIEZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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