Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2021-07-07FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
There is a potential that the pressure tubing may detach from the blood sampling system
- 2021-07-07FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
There is a potential that the pressure tubing may detach from the blood sampling system
- 2021-07-07FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
There is a potential that the pressure tubing may detach from the blood sampling system
- 2021-07-07FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
There is a potential that the pressure tubing may detach from the blood sampling system
- 2021-07-07FDA-DeviceEdwards Lifesciences, LLCClass IIEdwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
There is a potential that the pressure tubing may detach from the blood sampling system
- 2021-07-07FDA-DeviceSynaptive Medical IncClass IISynaptive Trackable Suction Set Standard and Malleable
Due to visible burrs/metal filings affixed along the suction tube inner perimeter.
- 2021-07-07FDA-DeviceMagellan Diagnostics, Inc.Class ILeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
- 2021-07-07FDA-DeviceMagellan Diagnostics, Inc.Class ILeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
- 2021-07-07FDA-DeviceMagellan Diagnostics, Inc.Class ILeadCare II Blood Lead Test Kit Catalog Number 70-6762
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
- 2021-07-07FDA-DeviceQuidel CorporationClass ILyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
- 2021-07-07FDA-DeviceGE Healthcare, LLCClass IIRevolution EVO, Optima CT660, Optima CT680 CT Systems.
Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
- 2021-06-30FDA-DeviceSmith & Nephew, Inc.Class IILEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
- 2021-06-30FDA-DeviceEHOB, Inc.Class IIEconocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP
Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates
- 2021-06-30FDA-DeviceMedical Action Industries, Inc. 306Class IIMedical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
- 2021-06-30FDA-DeviceMedical Action Industries, Inc. 306Class IIMedical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
- 2021-06-30FDA-DeviceMedical Action Industries, Inc. 306Class IInovaplus, General Purpose Kit, Cat. No. 56603
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
- 2021-06-30FDA-DeviceMedical Action Industries, Inc. 306Class IIMedical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
- 2021-06-30FDA-DeviceMedical Action Industries, Inc. 306Class IIMedical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
- 2021-06-30FDA-DeviceBioFire Diagnostics, LLCClass IIFilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
- 2021-06-30FDA-DeviceInlightened Partners LLCClass IIIinLight Medical LED Pads used with Polychromatic light technology system
LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIOPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIVAPORIZER VICKS 1.5GAL Item Number: 2354942
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIDEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
- 2021-06-30FDA-DeviceCardinal Health Inc.Class IIBD UF PEN 32GX4MM 100 NANO Item Number: 4292272
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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