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.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceExactech, Inc.Class IIExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
- 2021-07-28FDA-DeviceCaption HealthClass IIVersion: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)
The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.
- 2021-07-28FDA-DeviceSouthwest Technologies IncClass IIStimulen Collagen Moisturizing Lotion, ST9555B
Dose audit failure after sterilization process
- 2021-07-28FDA-DeviceMindray DS USA, Inc. dba Mindray North AmericaClass III3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
Telepack may not power on when using the 3AA battery cradle.
- 2021-07-28FDA-DeviceArthrex, Inc.Class IISuture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
- 2021-07-28FDA-DeviceCell Marque CorporationClass IICell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Product distributed for use as an In-vitro Diagnostics without FDA clearance
- 2021-07-28FDA-DeviceCell Marque CorporationClass IICell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Product distributed for use as an In-vitro Diagnostics without FDA clearance
- 2021-07-28FDA-DeviceEncore Medical, LPClass IIDJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
- 2021-07-28FDA-DeviceEncore Medical, LPClass IIDJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
- 2021-07-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IIMedtronic Reveal LINQ LNQ11 / PA96000
Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.
- 2021-07-28FDA-DeviceStryker SpineClass IICortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
- 2021-07-28FDA-DeviceStryker SpineClass IICortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
- 2021-07-28FDA-DeviceRandox Laboratories Ltd.Class IINEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples
- 2021-07-28FDA-DeviceSoft Computer Consultants, Inc.Class IISoftCytogenetics
Software is given wrong results going out to HIS on test that had reruns.
- 2021-07-28FDA-DeviceDutch Ophthalmic USA, Inc.Class IIIlluminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01
- 2021-07-28FDA-DeviceMediana Co., Ltd.Class IIAVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.
In some cases the equipment fails to power up and/or key or button unresponsive or not working.
- 2021-07-28FDA-DeviceCardinal Health 200, LLCClass IIInfant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
- 2021-07-28FDA-DeviceCardinal Health 200, LLCClass IIInfant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws
A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.
- 2021-07-28FDA-DeviceSoft Computer Consultants, Inc.Class IISoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in ordering, specimen processing (pre-analytical steps), testing, documentation, and reporting.
Software showing wrong results reported, PDF not match HIS.
- 2021-07-28FDA-DeviceGentherm Medical, LLCClass IIHemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surgery which could lead to patient infection.
- 2021-07-28FDA-DeviceDutch Ophthalmic USA, Inc.Class IIDisposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the correct product code 1281.B1D06
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class II050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIThe MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay"safe Patient Connectors (K041792). The MTS Set consists of two (2) stay"safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler se
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IIThe Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IINaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osm
Exposed to freezing temperatures due to refrigerated truck malfunctions
- 2021-07-28FDA-DeviceFresenius Medical Care Holdings, Inc.Class IICitrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradi
Exposed to freezing temperatures due to refrigerated truck malfunctions
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief