Skip to main content
High RiskFDA
Teleflex Medical
Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in ...
Medical Implants·8,220 affected·Aug 8, 2013
High RiskFDA
Philips Healthcare Inc.
Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
Diagnostic Devices·89 affected·Aug 8, 2013
High RiskFDA
Megadyne Medical Products, Inc.
E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. T...
Surgical Devices·1,816 affected·Aug 7, 2013
High RiskFDA
Ge Healthcare, Llc
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and ser...
Diagnostic Devices·225 affected·Aug 7, 2013
High RiskFDA
Showline Automotive Products, Inc. Dba Us Soaps Mfg. Company
REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia...
Drugs·11,520 affected·Aug 6, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sr...
Oral Drugs·9,003 affected·Aug 6, 2013
High RiskFDA
Novartis Consumer Health
Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit fl...
Oral Drugs·3,451,224 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
Medical Devices·18,919 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
Medical Devices·4,452 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 Biodegradable suture anchor
Medical Devices·725 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
Medical Devices·5,873 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Bio...
Medical Devices·2,038 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
Medical Devices·17,696 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
Medical Devices·10,296 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part Number: 72202608 Biodegradable suture anchor
Medical Devices·1,308 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
Medical Devices·6,373 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Number: 72202603 Biodegradable suture anchor
Medical Devices·0 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor
Medical Devices·3,827 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 72202602 Biodegradable suture anchor
Medical Devices·7,148 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable suture anchor
Medical Devices·24,574 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biodegradable suture anchor
Medical Devices·240 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable suture anchor
Medical Devices·1,643 affected·Aug 6, 2013
High RiskFDA
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202631 Biodegradable suture anchor
Medical Devices·708 affected·Aug 6, 2013
High RiskFDA
B. Braun Medical, Inc.
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Medical Devices·900 affected·Aug 5, 2013
High RiskFDA
3m Company/3m Espe Dental Products
3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns...
Medical Devices·3,409 affected·Aug 5, 2013
High RiskFDA
Toshiba American Medical Systems Inc
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
Diagnostic Devices·427 affected·Aug 5, 2013
High RiskFDA
Toshiba American Medical Systems Inc
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Diagnostic Devices·430 affected·Aug 5, 2013
High RiskFDA
3m Company - Health Care Business
3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for eithe...
Medical Devices·1,207 affected·Aug 5, 2013
High RiskFDA
American Health Packaging
Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Col...
Oral Drugs·1,536 affected·Aug 2, 2013
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart S...
Oral Drugs·0 affected·Aug 2, 2013
High RiskFDA
Getinge Usa Inc
Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured f...
Medical Devices·61,301,606,636 affected·Aug 2, 2013
High RiskFDA
Villa Radiology Systems Llc
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoro...
Medical Devices·22 affected·Aug 2, 2013
High RiskFDA
Gourmet Express Marketing, Inc.
Breaded, frozen shrimp packaged in plastic bags labeled in part: BREADED SHRIMP; NET WEIGHT; 2.0 LBS or 3 LBS
Seafood·856 affected·Aug 1, 2013
High RiskFDA
Nexus Pharmaceuticals Inc
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceutical...
Injectable Drugs·46,185 affected·Aug 1, 2013
High RiskFDA
Nidek Inc
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management softwa...
Medical Devices·86 affected·Aug 1, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous...
Medical Devices·374 affected·Aug 1, 2013
High RiskFDA
Evershing International Trading Inc.
Coconut Tree Brand; Mut Gung Non; Ginger Candy; Ing: Ginger, Sugar, Water Sold in 8 oz sealed plastic pouches, and 12 oz sealed shrink...
Snacks & Candy·0 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudo...
Medical Devices·369 affected·Jul 31, 2013
High RiskFDA
Depuy Spine, Inc.
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation...
Medical Devices·102 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is in...
Medical Devices·135 affected·Jul 31, 2013
High RiskFDA
Depuy Spine, Inc.
PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue ...
Medical Devices·198 affected·Jul 31, 2013
High RiskFDA
Depuy Spine, Inc.
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation o...
Medical Devices·118 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and f...
Medical Devices·166 affected·Jul 31, 2013
High RiskFDA
Boston Scientific Corporation
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are ind...
Surgical Devices·1,331 affected·Jul 31, 2013
High RiskFDA
Arrow International Inc
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central...
Surgical Devices·156 affected·Jul 31, 2013
High RiskFDA
Leica Biosystems Newcastle Ltd.
Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Bent...
Diagnostic Devices·1 affected·Jul 31, 2013
High RiskFDA
Synthes Usa Hq, Inc.
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and f...
Medical Devices·98 affected·Jul 31, 2013
High RiskFDA
West-ward Pharmaceutical Corp.
Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Ma...
Oral Drugs·1,000 affected·Jul 30, 2013