Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-08-11FDA-DeviceTenderneeds Fertility LLCClass IIHome Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
- 2021-08-11FDA-DeviceTenderneeds Fertility LLCClass IIFlex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
- 2021-08-11FDA-DeviceBAXTER HEALTHCARE CORPORATIONClass IIKaguya Automated Peritoneal Dialysis System
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
- 2021-08-11FDA-DeviceBAXTER HEALTHCARE CORPORATIONClass IISharesource Connectivity Platform for Use with the Amia Automated PD System
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
- 2021-08-11FDA-DeviceVerathon, Inc.Class IIIGlideScope Go Monitors
Handheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality.
- 2021-08-11FDA-DeviceStryker GmbHClass IINail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
The devices have a different inner diameter than the diameter specified on the outer box label.
- 2021-08-11FDA-DeviceStryker GmbHClass IINail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
The devices have a different inner diameter than the diameter specified on the outer box label.
- 2021-08-11FDA-DeviceROi CPS LLCClass IIRegard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
- 2021-08-11FDA-DeviceROi CPS LLCClass IIRegard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
- 2021-08-11FDA-DeviceROi CPS LLCClass IIRegard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
- 2021-08-04FDA-DeviceMerit Medical Systems, Inc.Class IIbasixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
- 2021-08-04FDA-DeviceINNOVATIVE TOMOGRAPHY PRODUCT GMBHClass IISemi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
- 2021-08-04FDA-DeviceINNOVATIVE TOMOGRAPHY PRODUCT GMBHClass IICoaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
- 2021-08-04FDA-DeviceINNOVATIVE TOMOGRAPHY PRODUCT GMBHClass IICoaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm); Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm); Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
- 2021-08-04FDA-DeviceGE OEC Medical Systems, IncClass IIOEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
- 2021-08-04FDA-DeviceGE OEC Medical Systems, IncClass IIOEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
- 2021-08-04FDA-DeviceMedtronic NeuromodulationClass IIMedtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.
- 2021-08-04FDA-DeviceSunrise Medical (US) LLCClass IIZippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
- 2021-08-04FDA-DeviceSunrise Medical (US) LLCClass IIZippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds.
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
- 2021-08-04FDA-DeviceHill-Rom, Inc.Class IIAffinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E
Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.
- 2021-08-04FDA-DeviceIon Beam Applications S.A.Class IIProteus 235-Proton Therapy System
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
- 2021-08-04FDA-DeviceCooperVision Inc.Class IISOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IIFRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IICLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IIMEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IICLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IICLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IISPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IICLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
- 2021-08-04FDA-DeviceCooperVision Inc.Class IICLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief