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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core Computed Tomography X-ray system
Medical Devices·135 affected·Oct 29, 2015
High RiskFDA
Csfpdx, Llc
Labeled "CSFISHERY COMMUNITY SUPPORTED FISHERY Wild Albacore Tuna, 64 oz.., Ingredients: Oregon Albacore Tuna, Sea Salt" Label is bla...
Seafood·142 affected·Oct 28, 2015
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm ...
Medical Implants·478 affected·Oct 28, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Imaging VB36D_HF02. Radiological image processing system.
Medical Devices·3 affected·Oct 28, 2015
High RiskFDA
Masimo Corporation
rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DC...
Medical Devices·3,476 affected·Oct 28, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and co...
Medical Devices·496 affected·Oct 28, 2015
High RiskFDA
Baylis Medical Corp *
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infus...
Surgical Devices·433 affected·Oct 28, 2015
High RiskFDA
Quest Medical, Inc.
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Deliv...
Medical Devices·18,761 affected·Oct 28, 2015
High RiskFDA
Herrs Foods Inc
Herr's Sour Cream & Onion Flavored Potato Chips
Dairy·231,120 affected·Oct 27, 2015
High RiskFDA
Bauli
Doria AUTHENTIC ITALIAN GOODNESS, Amaretti BISCUITS, Net Wt. 8.81 oz (250g), UPC 799540801696, BAULI S.p.A Via Verdi, 31 37060 Castel d'A...
Food·495 affected·Oct 27, 2015
High RiskFDA
Geritrex Corp
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY ...
Drugs·844,704 affected·Oct 27, 2015
High RiskFDA
Geritrex Corp
Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use...
Topical Drugs·9,948 affected·Oct 27, 2015
High RiskFDA
Geritrex Corp
Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Dist...
Drugs·3,796 affected·Oct 27, 2015
High RiskFDA
Steris Corp
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue,...
Drugs·3 affected·Oct 27, 2015
High RiskFDA
Geritrex Corp
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount V...
Topical Drugs·1,032 affected·Oct 27, 2015
High RiskFDA
Procedure Products, Inc.
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further proces...
Surgical Devices·1,100 affected·Oct 27, 2015
High RiskFDA
Carl Zeiss Meditec Ag
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measuremen...
Medical Devices·1,882 affected·Oct 27, 2015
High RiskFDA
Merz North America, Inc.
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implan...
Medical Implants·9,439 affected·Oct 26, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiol...
Cardiac Devices·2 affected·Oct 26, 2015
High RiskFDA
Arthrocare Corporation
Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal pr...
Medical Devices·262 affected·Oct 26, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio with software version 10.1 LA.
Medical Devices·1 affected·Oct 26, 2015
High RiskFDA
Naturebox, Inc.
NatureBox Sticks 'n Stones; roasted nuts with sesame sticks 4.5 oz (128 g) pouches - UPC 8 52523 00546 4 and 5 lb. Corporate bags - no...
Dairy·8,202 affected·Oct 24, 2015
High RiskFDA
Otto Bock Healthcare Gmbh
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankl...
Medical Implants·273 affected·Oct 23, 2015
High RiskFDA
Medtronic Vascular, Inc.
Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210...
Surgical Devices·1,652 affected·Oct 23, 2015
High RiskFDA
Innokas Medical Oy
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
Medical Devices·424 affected·Oct 22, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 1100...
Surgical Devices·1,139 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, ...
Surgical Devices·206 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with di...
Surgical Devices·54 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674...
Surgical Devices·508 affected·Oct 21, 2015
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. ...
Surgical Devices·717 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and t...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Cook Inc.
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
Surgical Devices·38 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and ...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Lemaitre Vascular, Inc.
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and ...
Surgical Devices·4,315 affected·Oct 21, 2015
High RiskFDA
Eastland Food Corporation
Maesri Brand Shrimp Powder, 6.oz
Seafood·945 affected·Oct 20, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone ...
Medical Devices·9 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of mul...
Diagnostic Devices·200 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immuno...
Diagnostic Devices·7,482 affected·Oct 20, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone f...
Medical Devices·9 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
DrugSmart 11 Test Cup, Item No. 61127D; DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D; DrugSmart 9 Test Cup (BUP), Item No. 6096...
Diagnostic Devices·1,220 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative...
Diagnostic Devices·220 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA These Drugs of Abuse Tests are o...
Diagnostic Devices·150 affected·Oct 20, 2015
High RiskFDA
Ameditech Inc
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative d...
Diagnostic Devices·960 affected·Oct 20, 2015