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.
- 2018-03-21FDA-DeviceCook Inc.Class IICoons Interventional Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIBentson Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIBentson Plus Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIBentson Cerebral Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIAmplatz Ultra Stiff Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIAmplatz Stiff Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIAmplatz Extra Stiff Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-DeviceCook Inc.Class IIAmplatz Extra Stiff Whisker Wire Guide
Label does not state that the product is heparin-coated.
- 2018-03-21FDA-Device3M Company - Health Care BusinessClass IIACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.
- 2018-03-21FDA-Device3M Company - Health Care BusinessClass IIFUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.
- 2018-03-21FDA-DeviceArgo Medical Technologies LtdClass IIReWalk Personal 6.0. Catalog number: 50-20-0004.
Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.
- 2018-03-21FDA-DeviceIon Beam Applications S.A.Class IIProteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation lo
The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.
- 2018-03-21FDA-DeviceDraegar Medical Systems, Inc.Class IIINFINITY DUAL HEMO MCable Pod
Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
- 2018-03-21FDA-DeviceHowmedica Osteonics Corp.Class IIAccolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
Inner and outer sterile barriers not fully sealed.
- 2018-03-21FDA-DeviceHowmedica Osteonics Corp.Class IIAccolade and Restoration hip product; Catalog Number: 6720-0837 and 6721-0737
Inner and outer sterile barriers not fully sealed.
- 2018-03-21FDA-DeviceZimmer Biomet, Inc.Class IITrabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
Two lots of hip implants are mislabeled.
- 2018-03-21FDA-DeviceIon Beam Applications S.A.Class IIProteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
- 2018-03-21FDA-DeviceRandox Laboratories, LimitedClass IILiquid Cardiac Control CQ5053
Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.
- 2018-03-21FDA-DeviceMedtronic Minimally Invasive Therapies GroupClass IIArgyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.
Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.
- 2018-03-21FDA-DeviceBecton Dickinson & Co.Class IIDifco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required.
HighPuragar was mislabeled and inadvertently sold as Noble Agar.
- 2018-03-21FDA-DeviceIon Beam Applications S.A.Class IIProteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to th
An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate.
- 2018-03-21FDA-DeviceVygon MFG, Inc., dba/ Churchill Medical Systems, Inc.Class IIVygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
- 2018-03-14FDA-DeviceCypress Medical Products LLCClass II241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. McKesson Item # 241, 100123, and 100124, Cypress Item # 82-15 Manual surgical instrument for general use.
Product not meeting the iodine assay level requirements to support 36 month expiration dating.
- 2018-03-14FDA-DeviceIon Beam Applications S.A.Class IIProteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation locali
Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
- 2018-03-14FDA-DeviceIon Beam Applications S.A.Class IIProteus 235, graphite block 8
IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader
- 2018-03-14FDA-DeviceEuro Diagnostica ABClass IIDIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should b
Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009.
- 2018-03-14FDA-DeviceMedtronic Navigation, Inc.-LittletonClass IIO-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4) Model: BASE OARM Bl70000028230 SYS 230V, Product Number: Bl70000028230 (UDI: 00643169353992); (5) BASE OARM Bl70000028230R SYS 230V R
Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pendant bootup, Dose display/report, Gantry motion, Network communication, System shutdown, and Early termination of 3D spin.
- 2018-03-14FDA-DeviceMedtronic Navigation, Inc.-LittletonClass IIO-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Im
During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.
- 2018-03-14FDA-DeviceAbbott Point Of Care Inc.Class IIi-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue.
- 2018-03-14FDA-DeviceZ-Medica, LLCClass IIQuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
A customer complained that one of the pouches in a box of 10 had "QuikClot Roll" pouch instead of "QuikClot TraumaPad" pouch. The carton as well as the remaining 9 pouches were properly identified as QuikClot Trauma Pad. The customer alleged that when the pouch was opened, it contained a QuikClot TraumaPad. All 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (QuikClot TraumaPad).
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