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Medical device recalls reported in 2015

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ReportedRecallClassProductFirm
2015-08-19Z-2350-2015Class IIPathoDx Strep Grouping KitRemel Inc
2015-08-19Z-2351-2015Class IIPathoDx Strep B Grouping LatexRemel Inc
2015-08-19Z-2352-2015Class IIReSolve Locking Drainage Catheters The ReSolve Locking Catheters are…Merit Medical Systems, Inc.
2015-08-19Z-2353-2015Class IITrumpf Ceiling Mounted Surgical Lighting SystemsTrumpf Medical Systems, Inc.
2015-08-19Z-2354-2015Class IITrumpf Ceiling Mounted Surgical Lighting SystemsTrumpf Medical Systems, Inc.
2015-08-19Z-2355-2015Class IITrumpf Ceiling Mounted Surgical Lighting SystemsTrumpf Medical Systems, Inc.
2015-08-19Z-2356-2015Class IITrumpf Ceiling Mounted Surgical Lighting SystemsTrumpf Medical Systems, Inc.
2015-08-19Z-2357-2015Class IITrumpf Ceiling Mounted Surgical Lighting SystemsTrumpf Medical Systems, Inc.
2015-08-19Z-2358-2015Class IIInvacare¿ Pronto¿ Air Personal TransporterInvacare Corporation
2015-08-19Z-2359-2015Class II8Synthes (USA) Products LLC
2015-08-19Z-2360-2015Class IITriathlon PS X3 Tibial InsertStryker Howmedica Osteonics Corp.
2015-08-19Z-2361-2015Class IIi-Stat PT/INR Cartridges List number 03P89-24 The cartridges are…Abbott Point Of Care Inc.
2015-08-19Z-2363-2015Class IIReUnion TSA Shoulder SystemStryker Howmedica Osteonics Corp.
2015-08-19Z-2364-2015Class IIPerfectum Tuberculin Glass SyringeCadence Inc.
2015-08-19Z-2365-2015Class IIMicro-Mate Tuberculin Glass SyringeCadence Inc.
2015-08-19Z-2366-2015Class IIOasis Coil Extension Cable used with Hitachi Oasis MRI System Product…Hitachi Medical Systems America Inc
2015-08-19Z-2373-2015Class IINaturalyte Liquid Bicarbonate Concentrate 6Fresenius Medical Care Holdings, Inc.
2015-08-19Z-2375-2015Class IIWall Chart for STERRAD 100NX SystemAdvanced Sterilization Products
2015-08-19Z-2376-2015Class IIPSW 1203BIOTRONIK, Inc.
2015-08-19Z-2377-2015Class IIAngioJet Spiroflex Thrombectomy Set: PeripheralBoston Scientific Corporation
2015-08-19Z-2378-2015Class IIAngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001Boston Scientific Corporation
2015-08-19Z-2379-2015Class IIAngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001Boston Scientific Corporation
2015-08-19Z-2380-2015Class IIAngioJet AVX Thrombectomy Set: UPN 105039-001Boston Scientific Corporation
2015-08-19Z-2381-2015Class IIEtac Relax wall mounted shower seat The Etac Relax is a wall mounted…Etac Supply Center Ab
2015-08-19Z-2382-2015Class IICelsite Implantable Access Port SystemB. Braun Interventional Systems
2015-08-12Z-1991-2015Class IIOlympus Scientific Solutions Americas Analytical X-ray SystemOlympus Scientific Solutions Americas
2015-08-12Z-2264-2015Class IEnVeo R Loading SystemMedtronic Cardiovascular Surgery-the Heart Valve Division
2015-08-12Z-2317-2015Class IBeacon Tip Torcon NB Advantage CatheterCook Inc.
2015-08-12Z-2318-2015Class IBeacon Tip Royal Flush Plus High-Flow CatheterCook Inc.
2015-08-12Z-2319-2015Class ISlip-Cath Beacon Tip CatheterCook Inc.
2015-08-12Z-2324-2015Class IIMedtronic Passive Biopsy Needle KitMedtronic Navigation, Inc.
2015-08-12Z-2325-2015Class IIMedtronic Passive Biopsy Needle KitMedtronic Navigation, Inc.
2015-08-12Z-2326-2015Class IIS4C Occiput Torque Wrench F/Set ScrewAesculap, Inc.
2015-08-12Z-2327-2015Class IITitan Spine Endoskeleton Locking Bone Screw AssemblyTITAN SPINE, LLC
2015-08-12Z-2328-2015Class IIPhilips HeartStart XL+ Defibrillator/Monitor Product Usage: The…Philips Electronics North America Corporation
2015-08-12Z-2330-2015Class IIS2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184…Roche Diagnostics Operations, Inc.
2015-08-12Z-2331-2015Class IIBiograph mCT SSiemens Medical Solutions USA Inc.
2015-08-12Z-2332-2015Class IIBiograph mCT SSiemens Medical Solutions USA Inc.
2015-08-12Z-2333-2015Class IIBiograph mCT X-4RSiemens Medical Solutions USA Inc.
2015-08-12Z-2334-2015Class IISYS IVKSiemens Medical Solutions USA Inc.
2015-08-12Z-2335-2015Class IIBiograph mCT Flow Edge-4RSiemens Medical Solutions USA Inc.
2015-08-12Z-2336-2015Class IIBiograph 6-4R TruePoint w/ TrueVSiemens Medical Solutions USA Inc.
2015-08-12Z-2337-2015Class IIBiograph 64-4R TruePoint w/ TrueVSiemens Medical Solutions USA Inc.
2015-08-12Z-2338-2015Class IIBiograph 64-3R TruePoint w/ TrueVSiemens Medical Solutions USA Inc.
2015-08-12Z-2339-2015Class IIGE HealthcareGE Healthcare
2015-08-12Z-2340-2015Class IISiemens Artis zee systemsSiemens Medical Solutions USA, Inc
2015-08-12Z-2341-2015Class IIArtis Q systemsSiemens Medical Solutions USA, Inc
2015-08-12Z-2342-2015Class IIAxiom Artis systemsSiemens Medical Solutions USA, Inc
2015-08-12Z-2344-2015Class IIACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1…Siemens Medical Solutions USA, Inc.
2015-08-12Z-2345-2015Class IISynthes Battery Power Line II Oscillator Model 530The Anspach Effort, Inc.
2015-08-12Z-2346-2015Class IIAtrium 36Fr Right Angled Firm PVC Thoracic CatheterAtrium Medical Corporation
2015-08-12Z-2347-2015Class IIMerge HemoMerge Healthcare, Inc.
2015-08-12Z-2348-2015Class II18inch Dual Port/Single Bladder Disposable Tourniquet CuffZimmer Surgical Inc
2015-08-12Z-2349-2015Class II30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLCZimmer Surgical Inc
2015-08-05Z-2057-2015Class IIHamilton-G5 Ventilators with software versions V2Hamilton Medical, Inc.
2015-08-05Z-2209-2015Class IIInjectionPlasty 1Skeletal Kinetics, Llc
2015-08-05Z-2210-2015Class IICortical Pin 2Musculoskeletal Transplant Foundation, Inc.
2015-08-05Z-2211-2015Class IIMedical Device Exchange Surgical GownEXP Pharmaceutical Services Corp
2015-08-05Z-2212-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2213-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2214-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2215-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2216-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2217-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2218-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2219-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2220-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2221-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2222-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2223-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2224-2015Class IIMedical Device ExchangeEXP Pharmaceutical Services Corp
2015-08-05Z-2225-2015Class IIMedical Device Exchange -Suction CoagulatorEXP Pharmaceutical Services Corp
2015-08-05Z-2226-2015Class IIMedical Device Exchange -APPLIEREXP Pharmaceutical Services Corp
2015-08-05Z-2227-2015Class IIMedical Device Exchange -SYSTEMEXP Pharmaceutical Services Corp
2015-08-05Z-2228-2015Class IIMedical Device Exchange BAGEXP Pharmaceutical Services Corp
2015-08-05Z-2229-2015Class IIMedical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR…EXP Pharmaceutical Services Corp
2015-08-05Z-2230-2015Class IIMedical Device Exchange FIBERWIRE SUTURE SCISSOREXP Pharmaceutical Services Corp
2015-08-05Z-2231-2015Class IIMedical Device Exchange FEMORAL CANAL TIPEXP Pharmaceutical Services Corp
2015-08-05Z-2232-2015Class IIMedical Device Exchange Insufflation NeedleEXP Pharmaceutical Services Corp
2015-08-05Z-2233-2015Class IIMedical Device Exchange 10MM VASCULAREXP Pharmaceutical Services Corp
2015-08-05Z-2234-2015Class IIMedical Device Exchange 12MM VASCULAREXP Pharmaceutical Services Corp
2015-08-05Z-2235-2015Class IIMedical Device Exchange PT WIRE 300EXP Pharmaceutical Services Corp
2015-08-05Z-2236-2015Class IIMedical Device Exchange X-SAW BLADEEXP Pharmaceutical Services Corp
2015-08-05Z-2237-2015Class IIMedical Device Exchange WireEXP Pharmaceutical Services Corp
2015-08-05Z-2238-2015Class IIMedical Device Exchange Round Fluted Bur Soft TouchEXP Pharmaceutical Services Corp
2015-08-05Z-2239-2015Class IIMedical Device Exchange Round Diamond Bur Extra CoarseEXP Pharmaceutical Services Corp
2015-08-05Z-2240-2015Class IIMedical Device Exchange 6EXP Pharmaceutical Services Corp
2015-08-05Z-2241-2015Class IIMedical Device Exchange Round Fluted Bur AggressiveEXP Pharmaceutical Services Corp
2015-08-05Z-2242-2015Class IIMedical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cmEXP Pharmaceutical Services Corp
2015-08-05Z-2243-2015Class IIMedical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cmEXP Pharmaceutical Services Corp
2015-08-05Z-2244-2015Class IIMedical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation…EXP Pharmaceutical Services Corp
2015-08-05Z-2245-2015Class IIMedical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1EXP Pharmaceutical Services Corp
2015-08-05Z-2246-2015Class IIMedical Device Exchange 3EXP Pharmaceutical Services Corp
2015-08-05Z-2247-2015Class IIMedical Device Exchange 2EXP Pharmaceutical Services Corp
2015-08-05Z-2248-2015Class IIMedical Device Exchange 12x40 Airway Stent SystemEXP Pharmaceutical Services Corp
2015-08-05Z-2249-2015Class IIMedical Device Exchange 10x40 Airway Stent SystemEXP Pharmaceutical Services Corp
2015-08-05Z-2250-2015Class IIMedical Device Exchange Angio-Seal VIP Platform/Vascular Closure…EXP Pharmaceutical Services Corp
2015-08-05Z-2251-2015Class IIMedical Device Exchange Chocolate Balloon Catheter/Over-the-WireEXP Pharmaceutical Services Corp
2015-08-05Z-2252-2015Class IIMedical Device Exchange Aerosizer Stent Sizing DeviceEXP Pharmaceutical Services Corp
2015-08-05Z-2253-2015Class IIOxySure Model 615 disposable replacement cartridgesOxysure Systems, Inc.
2015-08-05Z-2254-2015Class IIComputed Tomography X-ray Systems Brilliance CT 64-channel with…Philips Medical Systems (Cleveland) Inc
2015-08-05Z-2255-2015Class IIComputed Tomography X-ray systems Brilliance iCTPhilips Medical Systems (Cleveland) Inc
2015-08-05Z-2256-2015Class IIComputed Tomography X-ray Systems Brilliance iCT SPPhilips Medical Systems (Cleveland) Inc
2015-08-05Z-2257-2015Class IIComputed Tomography X-ray Systems Ingenuity CorePhilips Medical Systems (Cleveland) Inc
2015-08-05Z-2258-2015Class IIComputed Tomography X-ray Systems Ingenuity Core 128Philips Medical Systems (Cleveland) Inc
2015-08-05Z-2259-2015Class IIComputed Tomography X-ray Systems Ingenuity CT scannersPhilips Medical Systems (Cleveland) Inc
2015-08-05Z-2260-2015Class IIMiniMed NGP 640G 1Medtronic MiniMed Inc.
2015-08-05Z-2261-2015Class IIOttobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric…Otto Bock Healthcare GmbH
2015-08-05Z-2262-2015Class IIFOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut BlockEncore Medical, Lp
2015-08-05Z-2263-2015Class IIParagon Laboratory ManagementMcKesson Technologies, Inc.
2015-08-05Z-2265-2015Class IIIPS Empress Universal Glaze Spray 270 mLIvoclar Vivadent, Inc.
2015-08-05Z-2266-2015Class IIInvivo Expression MRI Patient Monitoring SystemPhilips Electronics North America Corporation
2015-08-05Z-2267-2015Class IIOxiMax N-65 Handheld Pulse OximeterCovidien LP (formerly Nellcor Puritan Bennett Inc.)
2015-08-05Z-2268-2015Class IIOxiMax N-560 Pulse OximeterCovidien LP (formerly Nellcor Puritan Bennett Inc.)
2015-08-05Z-2269-2015Class IIPrism Medical P-440 Portable Ceiling LiftErgoSafe Products, LLC (DBA) Prism Medical
2015-08-05Z-2270-2015Class IIPrism Medical P-600 Portable Ceiling LiftErgoSafe Products, LLC (DBA) Prism Medical
2015-08-05Z-2271-2015Class IIFabius MRI Anesthesia MachineDraeger Medical, Inc.
2015-08-05Z-2272-2015Class IISynthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0Synthes (USA) Products LLC
2015-08-05Z-2273-2015Class IIHardy Diagnostics MacConkey Agar with CiPRPHardy Diagnostics
2015-08-05Z-2274-2015Class IIHardy Diagnostics BHI with CIPROHardy Diagnostics
2015-08-05Z-2275-2015Class IIHardy Diagnostics MDR Acinetobacter container type: 15x100mm…Hardy Diagnostics
2015-08-05Z-2276-2015Class IIHardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm…Hardy Diagnostics
2015-08-05Z-2277-2015Class IIHardy Diagnostics BEA Agar with VGA container type: 15x100mm…Hardy Diagnostics
2015-08-05Z-2278-2015Class IIHardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm…Hardy Diagnostics
2015-08-05Z-2279-2015Class IIHardy Diagnostics VRE BrothHardy Diagnostics
2015-08-05Z-2280-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2281-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2282-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2283-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2284-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2285-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2286-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2287-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2288-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2289-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2290-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2291-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2292-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2293-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2294-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2295-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2296-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2297-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2298-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2299-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2300-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2301-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2302-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2303-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2304-2015Class IIANSPACH -1The Anspach Effort, Inc.
2015-08-05Z-2305-2015Class IIANSPACH -3MM Coarse Diamond BallThe Anspach Effort, Inc.
2015-08-05Z-2306-2015Class IIANSPACH -4MM Carbide Fluted BallThe Anspach Effort, Inc.
2015-08-05Z-2307-2015Class IIANSPACH -4MM Coarse Diamond BallThe Anspach Effort, Inc.
2015-08-05Z-2308-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2309-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2310-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2311-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2312-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2313-2015Class IIANSPACHThe Anspach Effort, Inc.
2015-08-05Z-2314-2015Class IIACUSON S 1000Siemens Medical Solutions USA, Inc.
2015-08-05Z-2315-2015Class IIAequalis Humeral Nail Targeting JigTornier, Inc
2015-08-05Z-2316-2015Class IISYMMETRY SURGICAL DISPOSABLE TOWEL CLAMPSymmetry Surgical, Inc.
2015-08-05Z-2321-2015Class IIACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual…Siemens Medical Solutions USA, Inc.
2015-08-05Z-2322-2015Class IIIMission -Breath Alcohol Detector -15 testsAcon Laboratories, Inc.
2015-07-29Z-1838-2015Class IIPROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi…Hitachi America, Ltd., Power Systems Division
2015-07-29Z-2069-2015Class IVarious OxyTOTE Portable Oxygen System regulatorsWestern / Scott Fetzer Company
2015-07-29Z-2096-2015Class IISafety PICC Insertion Tray with Chloraprep OneStepCustom Healthcare Systems, Inc.
2015-07-29Z-2097-2015Class IIMagnus Hybrid OR Table ColumnMaquet Cardiovascular Us Sales, Llc
2015-07-29Z-2098-2015Class IIMilex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product…CooperSurgical, Inc.
2015-07-29Z-2099-2015Class II0702-001-350QStryker Instruments Div. of Stryker Corporation
2015-07-29Z-2100-2015Class IIRing Transjugular Intrahepatic Access Set Product Usage: The Ring…Cook Inc.
2015-07-29Z-2101-2015Class IIFlexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding…Cook Inc.
2015-07-29Z-2102-2015Class IIStryker SelectCore Variable Throw Biopsy DeviceStryker Instruments Div. of Stryker Corporation
2015-07-29Z-2103-2015Class IINatrelle 133 Series Tissue Expanders Product Usage: Natrelle 133…Allergan Inc
2015-07-29Z-2104-2015Class IINatrelle CUI Series Tissue ExpandersAllergan Inc
2015-07-29Z-2105-2015Class IIEVac 70 XTRA with Integrated Cable and PROcise EZ View with…ArthroCare Corporation
2015-07-29Z-2106-2015Class IICovidien Devon Light GlovesCovidien LLC
2015-07-29Z-2107-2015Class IIDelivery/C-SectionCovidien LLC
2015-07-29Z-2108-2015Class IIMini-KitsCovidien LLC
2015-07-29Z-2109-2015Class IIMinor Surgical KitsCovidien LLC
2015-07-29Z-2110-2015Class IISurgical Set Up kitCovidien LLC
2015-07-29Z-2111-2015Class IIASCCovidien LLC
2015-07-29Z-2112-2015Class IISurgical Kit Sterile-Kits containing the Devon Light Glove Catalog…Covidien LLC
2015-07-29Z-2113-2015Class IIDouble Basin KitCovidien LLC
2015-07-29Z-2114-2015Class IIMajor KitCovidien LLC
2015-07-29Z-2115-2015Class IISingle Basin KitsCovidien LLC
2015-07-29Z-2116-2015Class IIAugmentation KitCovidien LLC
2015-07-29Z-2117-2015Class IINS-3600-B LITE GLOVE 1000/CASE -BulkCovidien LLC
2015-07-29Z-2118-2015Class IINon Sterile Subassembly: Catalog Number/Description: SA1008…Covidien LLC
2015-07-29Z-2119-2015Class IIHysto PackCovidien LLC
2015-07-29Z-2120-2015Class IIGE Healthcare Precision 500D Classical R & F systemGE Healthcare
2015-07-29Z-2121-2015Class IIGE Healthcare Precision RXi 23A/32A Analog SystemGE Healthcare
2015-07-29Z-2122-2015Class IIGE Healthcare Precision RXi Digital systemGE Healthcare
2015-07-29Z-2123-2015Class IIGE HealthcareGE Healthcare
2015-07-29Z-2124-2015Class IIPerkin Elmer WIZARD2 1-detectorPerkinelmer
2015-07-29Z-2125-2015Class IIWIZARD2 2-detectorPerkinelmer
2015-07-29Z-2126-2015Class IIWIZARD2 5-detectorPerkinelmer
2015-07-29Z-2127-2015Class IIPerkin Elmer WIZARD2 10-detectorPerkinelmer
2015-07-29Z-2128-2015Class IIPerkin Elmer WIZARD2 5-detectorPerkinelmer
2015-07-29Z-2129-2015Class IIPerkin Elmer WIZARD2 10-detectorPerkinelmer

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