Medical device recalls
38750 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-03-02FDA-DeviceBiomet, Inc.Class IIComprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
- 2022-03-02FDA-DeviceBiomet, Inc.Class IIComprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
- 2022-03-02FDA-DeviceBiomet, Inc.Class IIComprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
- 2022-03-02FDA-DeviceBiomet, Inc.Class IIComprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
- 2022-03-02FDA-DeviceBiomet, Inc.Class IIArcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
- 2022-03-02FDA-DeviceCollagen Matrix, Inc.Class IIRESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
- 2022-03-02FDA-DeviceCollagen Matrix, Inc.Class IIDuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
- 2022-03-02FDA-DeviceC.R. Bard IncClass IIBARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
There is a potential to leak from the catheter where it connects to the drain bag
- 2022-03-02FDA-DeviceC.R. Bard IncClass IIBARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
There is a potential to leak from the catheter where it connects to the drain bag
- 2022-03-02FDA-DeviceBecton Dickinson & CompanyClass IIIBD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
- 2022-03-02FDA-DeviceStryker Sustainability SolutionsClass IIREF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
- 2022-03-02FDA-DeviceNatus Neurology DBA Excel Tech., Ltd. (XLTEK)Class IIIPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.
- 2022-03-02FDA-DeviceBALT USA, LLCClass IIThe Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device
Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.
- 2022-03-02FDA-DeviceNobel Biocare Usa LlcClass IINobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
- 2022-03-02FDA-DeviceMedtronic Vascular, Inc.Class IIEndurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF3216C120EE; ENBF3216C145EE; ENBF3216C170EE; ENBF3616C145EE; ENBF3616C170EE;
Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
- 2022-03-02FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMichels Transport Medium, 20ML Prefilled Cont
Product stored incorrectly in temperature controlled setting instead of refrigeration.
- 2022-02-23FDA-DeviceSmiths Medical ASD Inc.Class IIMedfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
- 2022-02-23FDA-DeviceHowmedica Osteonics Corp.Class IIExeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
- 2022-02-23FDA-DeviceHowmedica Osteonics Corp.Class IIExeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
- 2022-02-23FDA-DeviceMerete Medical GmbHClass IIMerete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Incorrect marketing label (25 mm) was applied to product size 20 mm.
- 2022-02-23FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIVeradius Unity, Model #718132
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
- 2022-02-23FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIZenition 70, Model #718133
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
- 2022-02-23FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIZenition 50, Model #718096
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
- 2022-02-23FDA-DeviceOscor Inc.Class IIDestino Twist 14F (also branded as Guidestar 14F)
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
- 2022-02-23FDA-DeviceHowmedica Osteonics Corp.Class IIDall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
- 2022-02-23FDA-DeviceHowmedica Osteonics Corp.Class II32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
- 2022-02-23FDA-DeviceEnvisiontec US LlcClass IIFLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
- 2022-02-23FDA-DeviceEnvisiontec US LlcClass IIFLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
- 2022-02-23FDA-DeviceMicrobiologics IncClass IIIKWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Some of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
- 2022-02-23FDA-DeviceHill-Rom, Inc.Class IILiko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
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