Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-06-22FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICrome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Quad: DTPC2QQ, DTPC2Q1
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- 2022-06-22FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt HF: DTPB2D4, DTPB2D1; g) Cobalt XT HF Quad: DTPA2QQ, DTPA2Q1; h) Cobalt HF Quad: DTPB2QQ, DTPB2Q1
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- 2022-06-22FDA-DeviceGE Healthcare, LLCClass IICARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #2082293-002, FRU MP200 CPU ASSEMBLY; (4) Part #2071523-001, MP200 22 IN DISPLAY WITH TOUCH; (5) Part #2092930-001, DSP LCD 22 IN MED W/TCH W/DKST N AMR; (6) Part #2092930-002, DSP LCD 22 IN MED W/TCH W/DK
The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.
- 2022-06-22FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
- 2022-06-22FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus URETERO-RENO FIBERSCOPE Model: URF-P6
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
- 2022-06-22FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus CYSTONEPHROFIBERSCOPE Model: CYF-5
Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.
- 2022-06-22FDA-DeviceMicro Therapeutics, Inc.Class IIAXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil System REF QC-10-30-3D;
Due to incorrect size and configuration labeling of the detachable coil system.
- 2022-06-22FDA-DeviceIllumina, Inc.Class IIillumina Model NextSeq 550 Dx REF 20005715
cybersecurity vulnerability
- 2022-06-22FDA-DeviceIllumina, Inc.Class IIillumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
cybersecurity vulnerability
- 2022-06-22FDA-DeviceTandem Diabetes Care IncClass IIt:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
- 2022-06-22FDA-DeviceDraeger Medical, Inc.Class IDrager SafeStar 55, Catalog No. MP01790
Possible occlusion of filters due to manufacturing error.
- 2022-06-15FDA-DeviceEncore Medical, LPClass IIDJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
- 2022-06-15FDA-DeviceSteris CorporationClass IIReliance Synergy Washer/Disinfector
The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke and/or fire.
- 2022-06-15FDA-DeviceROi CPS LLCClass IIregard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003
Convenience kit contained Medline Endoscopy Bedside Cleaning products which were recalled.
- 2022-06-15FDA-DeviceMedminder Systems, Inc.Class IIMedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center.
Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feature(button) removed
- 2022-06-15FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
- 2022-06-15FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
- 2022-06-15FDA-DeviceNeuMoDx Molecular IncClass IINeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
- 2022-06-15FDA-DeviceROi CPS LLCClass IIRegard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Potential for the tip of the electrode to detach during use.
- 2022-06-15FDA-DeviceGetinge Usa Sales IncClass IIGetinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
- 2022-06-15FDA-DeviceGetinge Usa Sales IncClass IIGetinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
- 2022-06-15FDA-DeviceMedacta Usa IncClass IIGMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
- 2022-06-15FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
- 2022-06-15FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
- 2022-06-15FDA-DeviceHelena Laboratories, Corp.Class IIV8 Immunodisplacement Kit REF 1803
Due to microbial growth causing interference with interpretation.
- 2022-06-15FDA-DeviceSiemens Medical Solutions USA, IncClass IISensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
- 2022-06-15FDA-DeviceCook IncorporatedClass IITornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
- 2022-06-15FDA-DeviceCook IncorporatedClass IINester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G52738 MWCE-18-7-6-NESTER-01 G47341 MWCE-18-3-3-NESTER-01 G47332 MWCE-18-7-4-NESTER G52
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
- 2022-06-15FDA-DeviceCook IncorporatedClass IIHilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
- 2022-06-15FDA-DeviceOakworks IncClass IIOakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
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