Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-05-17FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IIStryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.
Product shipped proximate to or past the expiration date listed on the product label.
- 2017-05-17FDA-DeviceMentor Texas, LP.Class IIMentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Missing Dome Pack accessory.
- 2017-05-17FDA-DeviceAlmore International IncClass IIMicrofil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended to be sterilized by the dentist prior to each use. It is used for composite restoration development. The thin paddles shape light-cured composites. Paddles slide under the gum line to shape the margin. The flat ends contour the surfaces of the teeth and the thin edge is used to create esthetic highlights. Models: #96041 Gold Mic
Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. These products are not sterile and they are intended to be sterile prior to each use.
- 2017-05-17FDA-DeviceZimmer Biomet, Inc.Class IIRegenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumati
pegs shearing post-operatively
- 2017-05-17FDA-DeviceAbbott Medical Optics Inc. (AMO)Class IIHealon V, Part No. 10290045
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- 2017-05-17FDA-DeviceAbbott Medical Optics Inc. (AMO)Class IIHealon Pro, Part No. 10270012
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- 2017-05-17FDA-DeviceAbbott Medical Optics Inc. (AMO)Class IIHealon 5 Pro, Part No. 10270015
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- 2017-05-17FDA-DeviceAbbott Medical Optics Inc. (AMO)Class IIHealon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- 2017-05-17FDA-DeviceAbbott Medical Optics Inc. (AMO)Class IIHealon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- 2017-05-17FDA-DeviceAbbott Medical Optics Inc. (AMO)Class IIHealon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
- 2017-05-17FDA-DeviceSavaria Concord Lifts, Inc.Class IISavaria SL-1000 Stairlift
The electrical controller, combined with motor, causes feedback, damaging a component on the control board, starting a fire.
- 2017-05-17FDA-DeviceZimmer Biomet, Inc.Class IIBone Dowell Harvest Tubes
mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
- 2017-05-17FDA-DeviceStryker Medical Division of Stryker CorporationClass IIMedi-Therm Hyper/Hypothermia System, MTA7900
The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water temperature, and then switched back to "Automatic" mode.
- 2017-05-17FDA-DeviceMed-Hot Thermal Imaging, Inc.Class IIMEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.
Indications for use are not cleared or approved for market in the U.S.
- 2017-05-17FDA-DeviceZimmer Biomet, Inc.Class IICobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.
- 2017-05-17FDA-DeviceGreatbatch MedicalClass IILinear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.
- 2017-05-17FDA-DeviceCooperSurgical, Inc.Class IICooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructio
The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.
- 2017-05-17FDA-DeviceMederi Therapeutics, IncClass IIMederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Product sterility compromised due to breach in sterile barrier package
- 2017-05-17FDA-DeviceRoche Diagnostics CorporationClass IISample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combi
Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affected sample probe may dip into the sample material deeper than intended. This may lead to carryover and medical risk cannot be excluded.
- 2017-05-17FDA-DeviceOrthosoft, Inc. dba Zimmer CASClass IINDI P7 Position Sensor, Stereotaxic Instrument
Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.
- 2017-05-17FDA-DeviceMedtronic Sofamor Danek USA IncClass IIMedtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
- 2017-05-17FDA-DeviceArthrex, Inc.Class IIAnthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Some eyelets broke from SwiveLock Anchor on insertion.
- 2017-05-17FDA-DeviceArthrex, Inc.Class IIAnthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Some eyelets broke from SwiveLock Anchor on insertion.
- 2017-05-17FDA-DeviceArthrex, Inc.Class IIAnthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Some eyelets broke from SwiveLock Anchor on insertion.
- 2017-05-17FDA-DeviceArthrex, Inc.Class IIAnthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Some eyelets broke from SwiveLock Anchor on insertion.
- 2017-05-17FDA-DeviceArthrex, Inc.Class IIAnthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Some eyelets broke from SwiveLock Anchor on insertion.
- 2017-05-17FDA-DeviceArthrex, Inc.Class IIAnthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Some eyelets broke from SwiveLock Anchor on insertion.
- 2017-05-17FDA-DeviceSiemens Healthcare Diagnostics IncClass IIRAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306
Potential Patient Demographic Error with Blank Patient ID Field
- 2017-05-17FDA-DeviceSmith & Nephew, Inc.Class IIPERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
This lot of left plates were laser etched and packaged as right plates.
- 2017-05-10FDA-DeviceBeckman Coulter Inc.Class IIAQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).
Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.
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