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.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIIKWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceBaxter Healthcare CorporationClass IIBaxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- 2022-02-16FDA-DeviceR82 A/SClass IIR82 by ETAC Push Brace for High-Low
The chrome surface of the push brace can crack during use, potentially cutting the user.
- 2022-02-16FDA-DeviceMallinckrodt Pharmaceuticals Ireland LtdClass IITHERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.
- 2022-02-16FDA-DeviceAvanos Medical, Inc.Class IIMIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
- 2022-02-16FDA-DeviceAvanos Medical, Inc.Class IIMIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
- 2022-02-16FDA-DeviceE25Bio, Inc.Class IE25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
- 2022-02-16FDA-DeviceArgon Medical Devices, IncClass II1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
- 2022-02-16FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINovalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
- 2022-02-16FDA-DeviceGentueri IncClass IIGentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Kits failed sterility testing and showed evidence of contamination.
- 2022-02-09FDA-DeviceCELLTRION USA INCClass IICelltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
- 2022-02-09FDA-DeviceCovidien LlcClass IIChameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
- 2022-02-09FDA-DeviceFEMSelect LtdClass IIThe EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.
Certain lots may not have been packaged wth the Channel Tube Limiter.
- 2022-02-09FDA-DeviceYoung Dental Mfg Co I LLCClass IIYOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.
The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
- 2022-02-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIHARDY DIAGNOSTICS CatScreen, 25dsk/vial
Product stored incorrectly in temperature controlled setting instead of refrigeration.
- 2022-02-09FDA-DeviceLuminex CorporationClass IIARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
- 2022-02-09FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIPremier Rotaclone, Rx only
Product stored incorrectly in temperature controlled setting instead of refrigeration.
- 2022-02-09FDA-DeviceOlympus Corporation of the AmericasClass IISpiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
- 2022-02-09FDA-DeviceAbiomed, Inc.Class IOXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia.
- 2022-02-09FDA-DevicePhilips North America LlcClass IIeCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. Model Number: 865325
eCareManager (eCM) Sentry Score software not approved for use
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