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.
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceZOLL Circulation, Inc.Class IIZoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- 2021-10-13FDA-DeviceCardioQuip, LLCClass IICardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-13FDA-DeviceCardioQuip, LLCClass IICardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-13FDA-DeviceCardioQuip, LLCClass IICardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-13FDA-DeviceCardioQuip, LLCClass IICardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
- 2021-10-13FDA-DeviceFlower Orthopedics CorporationClass IIFlower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)
- 2021-10-13FDA-DeviceSentinel CH SpAClass IIIAlinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to generate a warning that calibrators are incorrectly loaded and calibration will not be completed successfully.
- 2021-10-13FDA-DeviceBeckman Coulter Inc.Class IIAccess hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.
- 2021-10-13FDA-DeviceNOX MEDICALClass IINox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Error in the device firmware results in the inaccurate detection of device position.
- 2021-10-13FDA-DeviceContamac Solutions, Inc.Class IINutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
Contact lens solution may contain foreign material
- 2021-10-13FDA-DeviceAesthetics Systems Usa IncClass IAction De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
- 2021-10-13FDA-DeviceJohnson & Johnson Surgical Vision IncClass IITECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
- 2021-10-13FDA-DeviceExactech, Inc.Class IIARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DeviceExactech, Inc.Class IIOPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DeviceExactech, Inc.Class IIOPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DeviceExactech, Inc.Class IIVantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DeviceExactech, Inc.Class IITRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DeviceExactech, Inc.Class IIOPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line: 900-33-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DeviceExactech, Inc.Class IIOPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DeviceExactech, Inc.Class IIOPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DeviceExactech, Inc.Class IIOPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 24
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
- 2021-10-13FDA-DevicePaltop Advanced Dental Solutions LtdClass IIScan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
- 2021-10-13FDA-DevicePaltop Advanced Dental Solutions LtdClass IIScan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
- 2021-10-13FDA-DevicePaltop Advanced Dental Solutions LtdClass IIScan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
- 2021-10-13FDA-DevicePaltop Advanced Dental Solutions LtdClass IIScan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
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