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.
- 2018-05-02FDA-DeviceIntegra LifeSciences Corp.Class IIThe humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
- 2018-05-02FDA-DeviceHowmedica Osteonics Corp.Class IITriathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Customers may receive the incorrect size implant from what is labeled on the box.
- 2018-05-02FDA-DeviceCrimson Trace CorporationClass IICrimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW.
- 2018-04-25FDA-DeviceCook Inc.Class IICook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
- 2018-04-25FDA-DeviceCook Inc.Class IICook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
- 2018-04-25FDA-DeviceTMJ Solutions IncClass IIPatient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or
This device was mislabeled and is not the correct component for this patient.
- 2018-04-25FDA-DeviceKeystone Dental IncClass IIStage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIT5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIMultiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIT10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIT5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIIngenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIConversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIAchieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.5T Model 781382 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIPanorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIIntera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174, 11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIIntera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIIntera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DevicePhilips Electronics North America CorporationClass IIMultiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
- 2018-04-25FDA-DeviceHalyard Health, IncClass IIHalyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* M
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
- 2018-04-25FDA-DeviceHalyard Health, IncClass IIHalyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH CARE-72 DSE ENDO 14FR; c. HALYARD* TRACH CARE-72 WET PAK* 14FR; d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR; e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN); f. HALYARD* TRACH CARE-72 DS
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
- 2018-04-25FDA-DeviceHalyard Health, IncClass IIHalyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE DSE TRACH; e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); f. HALYARD* 14FR TRACH CARE DSE ENDO; g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); h. HALYARD* 14FR TRACH CA
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
- 2018-04-25FDA-DeviceCarefusion 2200 IncClass IIThoracentesis/ Paracentesis Kit 10/CS; STERILE;
The integrity of the sterile packaging is potentially compromised.
- 2018-04-25FDA-DeviceCarefusion 2200 IncClass IIJAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
The integrity of the sterile packaging is potentially compromised.
- 2018-04-25FDA-DeviceCarefusion 2200 IncClass IIJAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
The integrity of the sterile packaging is potentially compromised.
- 2018-04-25FDA-DeviceCarefusion 2200 IncClass IIILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
The integrity of the sterile packaging is potentially compromised.
- 2018-04-25FDA-DeviceCarefusion 2200 IncClass IIJAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
The integrity of the sterile packaging is potentially compromised.
- 2018-04-25FDA-DeviceCarefusion 2200 IncClass IIManometer, 550 ml three-Way Stopcock; STERILE;
The integrity of the sterile packaging is potentially compromised.
- 2018-04-25FDA-DeviceAutochairClass IIProduct: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B
Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the locking pin for latching the leg positions, product legs folded inwards while lifting a person off a bed and the individual was dropped.
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