September 2013 recalls

530 recalls were announced in September 2013.

What the numbers show

Critical: 15
Severe: 203
High: 216
Moderate: 81
Low: 15

Of the 530 recalls this month scored against our rubric, 3% are Critical, 38% are Severe.

Which agencies issued them

401–500 of 530

ModerateFDA (Devices)·Z-2138-2013·2013-09-11
Boston Scientific Recalls 4.0mm Flextome Cutting Balloon Devices
Boston Scientific is recalling 4.0mm x 15mm Flextome Cutting Balloon devices because users may be unable to remove the protector cap.
Product
Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm…
Category
Medical Device
Distribution
43 states
LowFDA (Food)·F-1875-2013·2013-09-11
Justin's Nut Butter Recalled for Foreign Metallic Fragments
Justin's Nut Butter is voluntarily recalling specific lots of Maple Almond Butter and Chocolate Hazelnut Butter due to the presence of foreign metallic fragments.
Product
Chocolate Hazelnut Butter 16oz Jar (Unit UPC 894455000490, Case UPC 894455000612)
Category
Food
Distribution
Distributed nationwide
LowFDA (Food)·F-1872-2013·2013-09-11
Greenland Trading Recalls El Basham Apricot Paste for Missing English Labeling
Greenland Trading Corp is recalling El Basham Apricot Dried Paste because the product does not declare its identity in English. The recall covers 100 cases distributed to five states.
Product
El Basham Weight 400 g Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil. Made by: For the Owner of the Trade Mark ABU Ode h Bros Co. Amok St. Aman -Jordan Tel +962 6 4914961 Fax +962 6 4907878 Remaining information is in Arabic.
Category
Food
Distribution
5 states
LowFDA (Food)·F-1869-2013·2013-09-11
La Terra Fina Spinach Artichoke Dip Recalled for Labeling Error
La Terra Fina is recalling one lot of Spinach Artichoke and Parmesan Dip because the label displays the ingredient and nutrition information for Caramelized Onion Dip.
Product
Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free. Net WT. 10 oz., (.625 lb,284g Made with real cream cheese. Plastic square tub La Terra Fina Union City, CA 94587
Category
Food
Distribution
4 states
LowFDA (Devices)·Z-2131-2013·2013-09-11
Copan WASP Instrument Recalled for Software Upgrade to Prevent Table Rotation
Copan Italia is recalling 63 WASP instruments to upgrade software and eliminate a very low risk of the broth table rotating while the door is open.
Product
WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes.
Category
Medical Device
Distribution
2 states
SevereNHTSA·13E050000·2013-09-10
Sure Power Recalls Electrical Components Due to Fire Risk
Sure Power is recalling battery equalizers and DC-DC converters because a potting compound can conduct electricity and cause fires.
Product
ELECTRICAL SYSTEM recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V414000·2013-09-10
Circle D Trailers Recalled for Door Lock Jamming Hazard
Circle D is recalling 2006-2013 horse and multipurpose trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside.
Product
CIRCLE D — CIRCLE D BHST, GNMPT, GNST
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V413000·2013-09-10
Open Range Travel Trailer Recall for Jamming Deadbolt Locks
Open Range is recalling 2009-2013 travel trailers because a defect in the deadbolt lock may jam, potentially trapping occupants inside the vehicle.
Product
OPEN RANGE — OPEN RANGE TRAVEL TRAILER
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·13279·2013-09-10
Be Amazing! Toys Recalls Monster Science Growing Spiders Due to Ingestion Hazard
Be Amazing! Toys is recalling Monster Science Growing Spider sets because the water-absorbing polymer balls can cause intestinal obstructions if swallowed by children.
Product
Water-absorbing polymer balls
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·13V411000·2013-09-10
Team Spirit Trailers Recall 2006-2013 Models Due to Door Lock Jamming Risk
Team Spirit is recalling 2006-2013 enclosed cargo trailers because a defect in the deadbolt lock could jam, potentially trapping occupants inside the vehicle.
Product
TEAM SPIRIT — TEAM SPIRIT TSDPL, TSPL, TSCDTS, TSCFTS
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·13278·2013-09-10
Eco-Novelty Recalls Jumbo Cosmo Beads Toys Due to Ingestion Hazard
Eco-Novelty is recalling Jumbo Size and Jumbo Multipurpose Cosmo Beads toys because the water-absorbing beads can cause intestinal obstructions if swallowed by children.
Product
Water-absorbing polymer beads
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·13V406000·2013-09-09
Micro Bird Recalls 2013 G5 School Buses for Ceiling Panel Defect
Micro Bird is recalling 2013 G5 school buses because improperly glued ceiling panels may separate in a crash, increasing injury risk.
Product
MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·13V410000·2013-09-09
Goshen Coach Recalls 2009-2010 Buses Due to Fire Risk
Goshen Coach is recalling 709 model year 2009 and 2010 buses because voltage spikes may damage door header circuit boards, increasing the risk of fire.
Product
GOSHEN — GOSHEN WOLVERINE, GC II, PACER II, SENTINEL
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13E051000·2013-09-09
Maxzone Recalls DEPO Headlamps for Ford F-150 Trucks
Maxzone is recalling DEPO-brand replacement headlamps for 2004-2008 Ford F-150 trucks because moisture inside the lens may reduce visibility and increase crash risk.
Product
EXTERIOR LIGHTING:HEADLIGHTS recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V415000·2013-09-09
Kingston Recalls Horse Trailers With Potentially Jamming Door Locks
Kingston is recalling 2006-2013 horse trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside.
Product
KINGSTON — KINGSTON BELVEDERE II, BRUNSWICK, BEDFORD, WINDSOR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V519000·2013-09-09
Play-Mor Trailers Recall 2006-2013 Models Due to Door Lock Defect
Play-Mor Trailers is recalling 2006-2013 travel trailers because a door lock defect could jam the deadbolt, trapping occupants inside.
Product
PLAY-MOR — PLAY-MOR SPORTSTER, PLAY-MOR, MOTORSPORT
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·13V408000·2013-09-06
Eldorado Recalls 2010 Buses Due to Door Header Fire Risk
Eldorado is recalling 2010 Aerotech, Aero Elite, and Aerolite buses because voltage spikes in door headers may cause overheating and fire.
Product
ELDORADO — ELDORADO AERO ELITE, AEROLITE, AEROTECH
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·13277·2013-09-06
Crosman Recalls Air Pistols Due to Explosion Hazard
Crosman is recalling specific air pistol models because they can explode at high temperatures, posing a risk of serious injury to users.
Product
Air pistols
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·13V404000·2013-09-06
Homesteader Recalls 2006-2010 Trailers Due to Door Lock Jamming Risk
Homesteader is recalling 2006-2010 enclosed cargo and horse trailers because a key removal issue may jam the deadbolt, potentially trapping occupants inside.
Product
HOMESTEADER — HOMESTEADER HORSE TRAILER, ENCLOSED CARGO TRAILER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V409000·2013-09-06
Jackson Mfg Recalls Travel Trailers With Potentially Jamming Door Locks
Jackson Mfg is recalling 2006-2013 travel trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside the vehicle.
Product
JACKSON MFG — JACKSON MFG TRAVEL TRAILER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V405000·2013-09-06
Suzuki Recalls Grand Vitara and SX4 for Air Bag Sensor Defect
Suzuki is recalling 2006-2011 Grand Vitara and 2007-2011 SX4 vehicles because the front passenger air bag sensor may fail, causing the air bag to deploy regardless of occupant size.
Product
SUZUKI — SUZUKI SX4, GRAND VITARA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·13V403000·2013-09-05
Freightliner Cascadia Trucks Recalled for Brake Caliper Bolt Torque Issues
Daimler Trucks North America is recalling 2014 Freightliner Cascadia trucks because brake caliper mounting bolts may be incorrectly torqued, potentially leading to reduced brake effectiveness.
Product
FREIGHTLINER — FREIGHTLINER CASCADIA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V401000·2013-09-05
Western Star 4900 Recalled for Seatbelt Anchor Misalignment
Daimler Trucks North America is recalling 2009-2014 Western Star 4900 trucks because a misaligned B-pillar hole may prevent seatbelts from restraining occupants properly in a crash.
Product
WESTERN STAR — WESTERN STAR 4900
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V402000·2013-09-05
ShowHauler Motorhomes Recalled for Door Lock Jamming Risk
ShowHauler is recalling 2006-2013 motorhomes because the door lock may jam, potentially trapping occupants inside the vehicle.
Product
SHOWHAULER — SHOWHAULER MOTORHOME
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1854-2013·2013-09-04
Heeren Brothers Recalls Athena Cantaloupes Due to Listeria Contamination
Heeren Brothers Produce is recalling Athena cantaloupes sold in Michigan after FDA testing found Listeria monocytogenes contamination.
Product
Cardboard BIN LABEL: 03808 LOT #: 09000101, MELON CANTALOUPE..., 80-90 CT , 07/22/13 cantaloupes themselves are not labeled.
Category
Food
Distribution
1 state
CriticalFDA (Drugs)·D-922-2013·2013-09-04
Hospira Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter
Hospira is recalling 264,432 bags of 0.9% Sodium Chloride Injection because the product may contain fibrous material.
Product
0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-919-2013·2013-09-04
Rugby Enteric Coated Aspirin 81 mg Recalled for Labeling Error
Advance Pharmaceutical Inc. is recalling 16,440 bottles of Enteric Coated Aspirin 81 mg due to a label mix-up where one bottle contained Acetaminophen 500 mg.
Product
ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1852-2013·2013-09-04
Buurma Farms Cilantro Recalled Due to Listeria monocytogenes Contamination
Buurma Farms is recalling fresh cilantro after a customer reported a positive Listeria monocytogenes test result from the Michigan Department of Agriculture.
Product
Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9
Category
Food
Distribution
4 states
CriticalFDA (Drugs)·D-921-2013·2013-09-04
Bethel 30 capsules recalled for undeclared active ingredients
Bethel Nutritional Consulting, Inc. is recalling Bethel 30 capsules because FDA analysis found undeclared sibutramine and phenolphthalein, making the product an unapproved new drug.
Product
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-920-2013·2013-09-04
Fresenius Kabi Recalls Magnesium Sulfate Injection Due to Glass Particulates
Fresenius Kabi is recalling 15,625 vials of Magnesium Sulfate Injection, USP, 50% due to the presence of glass particulate matter.
Product
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V395000·2013-09-04
Toyota Recalls Lexus Vehicles for Engine Component Bolt Failure Risk
Toyota is recalling specific Lexus GS 350, IS 350, and IS 350C vehicles because engine bolts may loosen, potentially causing the engine to stop while driving.
Product
LEXUS — LEXUS IS 350, GS 350, IS 350C
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2055-2013·2013-09-04
Zimmer Recalls Trabecular Metal Reverse Shoulder Glenosphere Distractor
Zimmer, Inc. is recalling 771 units of the Trabecular Metal Reverse Shoulder Glenosphere Distractor due to potential mechanical failure if used without proper lubrication.
Product
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-925-2013·2013-09-04
Nexus Pharmaceuticals Recalls Benztropine Mesylate Injection Due to Glass Particulates
Nexus Pharmaceuticals is recalling 46,185 vials of Benztropine Mesylate Injection due to the presence of glass delamination flakes.
Product
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V396000·2013-09-04
Toyota Recalls 2006-2010 Highlander and Lexus RX Hybrids for Inverter Defect
Toyota is recalling 2006-2010 Highlander and 2006-2008 Lexus RX hybrids because a defective inverter component may cause the vehicle to stall unexpectedly while driving.
Product
TOYOTA — TOYOTA, LEXUS HIGHLANDER HYBRID, RX HYBRID
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-918-2013·2013-09-04
Avastin Syringes Recalled for Sterility Concerns and Eye Infection Reports
Clinical Specialties Compounding Pharmacy is recalling Avastin syringes due to sterility assurance issues and reports of eye infections.
Product
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA
Category
Drug
Distribution
5 states
SevereFDA (Devices)·Z-2067-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox. Stem dia. 12 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2097-2013·2013-09-04
Megadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach
Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.
Product
E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is…
Category
Medical Device
Distribution
11 states
SevereFDA (Drugs)·D-927-2013·2013-09-04
Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns
Hospira Inc. is recalling 72,300 vials of Diazepam Injection due to ineffective crimps that may compromise sterility.
Product
DIAZEPAM — DIAZEPAM (DIAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-923-2013·2013-09-04
Novocol Recalls Subpotent Lidocaine and Epinephrine Dental Injection Lots
Novocol is recalling two lots of Lidocaine 2% with Epinephrine 1:100,000 injection because the epinephrine component may be subpotent.
Product
LIDOCAINE — LIDOCAINE (LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2077-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 9 trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox. Stem dia. 18 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
SevereFDA (Food)·F-1856-2013·2013-09-04
Whole Foods Recalls Sour Cherry Crostata for Unlabeled Egg Allergen
Whole Foods Market is recalling Sour Cherry Crostata pies because egg wash is used in the product but is not listed on the ingredient list or allergen statement.
Product
Sour Cherry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) Whole Foods Market Inc., Emeryville, CA 94608
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-2130-2013·2013-09-04
Stryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks
Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.
Product
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1853-2013·2013-09-04
See's Candies Recalls Dark Chocolate Blueberries Due to Missing Milk Labeling
See's Candies is recalling Dark Chocolate Blueberries because milk was omitted from the ingredient list. The product was distributed in the US, Hong Kong, and Taiwan.
Product
See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages. See's Candies Inc./See's Candy Shops Inc: South San Francisco, CA 94080/Los Angeles, CA 90016
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1851-2013·2013-09-04
Whole Foods Recalls Morbier Cheese Due to Listeria Risk
Whole Foods Market is recalling specific varieties of Trois Comtois Morbier cheese due to potential Listeria monocytogenes contamination linked to a French supplier recall.
Product
Trois Comtois Morbier Cheese labeled as follows: Morbier Raw Milk PLU 293358; Morbier AOC Le Trois PLU 293608; Morbier Raw Milk French Cheese PLU 293358; and Morbier Les Trois Comtois PLU 293608, Whole Foods Market
Category
Food
Distribution
15 states
SevereFDA (Food)·F-1857-2013·2013-09-04
Whole Foods Recalls Blueberry Crostata for Unlabeled Egg Allergen
Whole Foods Market is recalling Blueberry Crostata pies because egg wash is used in the product but is not listed on the ingredient or allergen statement.
Product
Blueberry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) UPC: 0216733009993 Whole Foods Market Inc., Emeryville, CA 94608
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1850-2013·2013-09-04
Les 3 Comtois Recalls Morbier Cheese Due to Listeria
Les 3 Comtois is recalling 83 cases of Morbier cheese distributed in California, Illinois, and Wisconsin because FDA analysis detected Listeria monocytogenes.
Product
Morbier Les 3 Comtois, 11 lb. wheel; packaged in a cardboard case; one per case; refrigerated
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-2090-2013·2013-09-04
Zimmer Free Lock Femoral Hip Fixation System Compression Lag Screw Recall
Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Lag Screws because a packaging failure compromised sterility.
Product
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2063-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox. Stem dia. 18 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2094-2013·2013-09-04
Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling Versa-FX II Femoral Fixation System units because a packaging configuration failed a leak test, compromising sterility.
Product
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2075-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/14, Stem size S-1, prox. Stem dia. 14 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2072-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling four trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/22, Stem size 05, prox. Stem dia. 22.5 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2092-2013·2013-09-04
Zimmer Recalls VERSA-FX Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.
Product
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1849-2013·2013-09-04
Tres Leches cake recalled for undeclared soy oil allergen
D'Aqui Manufacturing Products Corp. is recalling Tres Leches cakes sold in Puerto Rico due to undeclared soy oil.
Product
Tres Leches cake sold under the following brand names: 1) "****Tres Leches***Postres D'Aqui***D'Aqui Manufacturing Products Corp***Peso Neto 3oz***"; 2) "****Tres Leches***Fresh Star***Distribuido por Karelly's Food***PO Box 634 Sabana Seca PR 00952***Peso Neto 3 oz***"
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2116-2013·2013-09-04
GE Healthcare Recalls Patient Data Modules Due to Signal Noise
GE Healthcare is recalling CARESCAPE Patient Data Modules because movement of the ECG connector can cause signal noise, potentially reducing the device's ability to detect arrhythmias.
Product
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2065-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox. Stem dia. 22.5 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2064-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/20, Stem size 004, prox. Stem dia. 20 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2074-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox. Stem dia. 12 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2068-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 7 trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox. Stem dia. 14 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2061-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for a reconstruction prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox. Stem dia. 14 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2080-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling eight trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2114-2013·2013-09-04
Siemens ADVIA 120 Hematology Analyzer Recall for Optics Cover Failure
Siemens is recalling ADVIA 120 Hematology Analyzers because gas struts may fail, causing the top optics cover to fall during maintenance.
Product
ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2091-2013·2013-09-04
Zimmer Free Lock Femoral Hip Fixation System Recalled for Sterility Failure
Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, compromising product sterility.
Product
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2013·2013-09-04
GE Healthcare Recalls Dash Patient Monitors Due to Signal Noise
GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because movement of the ECG connector can cause intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.
Product
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2056-2013·2013-09-04
Integra Leyla Ball Joint Clamp Recalled for Potential Instability
Integra Limited is recalling 65 Leyla Ball Joint Clamps because they may not provide sufficient stability to maintain retraction during neurosurgery.
Product
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open…
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-2098-2013·2013-09-04
GE Ultrasound ViewPoint 6 Recalled for Incorrect Pulsatility Index Calculations
GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.
Product
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2079-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling nine trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2054-2013·2013-09-04
Stryker Recalls HydroSet Injectable HA Bone Substitute Due to Leaking Desiccant
Stryker is recalling HydroSet Injectable HA Bone Substitute kits because desiccant bags may leak silica gel, posing risks of foreign body reactions or increased anesthesia exposure.
Product
Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2084-2013·2013-09-04
Respironics V1000 Ventilator Recalled Due to Display Backlight Interruption
Respironics is recalling V1000 ventilators because power interruptions to the display backlight cause the screen to flicker or go dark, making it unreadable.
Product
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2066-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighNHTSA·13V400000·2013-09-04
Winnebago Recalls 2013-2014 Motorhomes Due to Child Seat Tether Defect
Winnebago is recalling 2013-2014 Aspect and Itasca Cambria motorhomes because the child seat tether is mounted improperly, which may fail to protect occupants in a crash.
Product
WINNEBAGO — WINNEBAGO, ITASCA ASPECT, CAMBRIA
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·13V399000·2013-09-04
Aliner Travel Trailer Recall for Door Lock Jamming Risk
Columbia Northwest is recalling 2006-2013 Aliner travel trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.
Product
ALINER — ALINER TRAVEL TRAILER
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2013·2013-09-04
GE Healthcare Recalls TRAM Modules Due to ECG Signal Noise
GE Healthcare is recalling TRAM Modules because movement of the ECG connector causes signal noise, which may reduce the accuracy of ECG, respiration, and arrhythmia monitoring.
Product
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2013·2013-09-04
Roche Recalls ACCU-CHEK FastClix Lancing Devices Due to Needle Retraction Defect
Roche Diagnostics is recalling 36,332 ACCU-CHEK FastClix Lancing Devices because the needle may not fully retract after use, posing a puncture risk.
Product
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2069-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling nine trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-1855.2013·2013-09-04
Quesos Vaca Negra cheese recalled for E. coli test results
Quesos Vaca Negra, Inc. is recalling specific cheese wheels in Puerto Rico after positive test results for generic E. coli.
Product
"***Que sos VACA NEGRA***CAP AEZ***Libre DE Lactose y Hormona R-BST***Quesos Vaca Negra, Carr 492 km 0.1, Hatillo, PR***"
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-2105-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Suction Wand Issue
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2073-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2076-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-926-2013·2013-09-04
Hospira Recalls Ketorolac Tromethamine Injections Due to Sterility Concerns
Hospira, Inc. is recalling 345,800 vials of Ketorolac Tromethamine Injection due to a lack of assurance of sterility caused by loose or missing crimps on fliptop vials.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-2095-2013·2013-09-04
Siemens Recalls Linear Accelerator Tabletops Due to Screw Breakage Risk
Siemens is recalling specific linear accelerator tabletops because manufacturing errors may cause screws to break off, potentially affecting patient safety.
Product
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2093-2013·2013-09-04
Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling 85,794 units of the Versa-FX II Femoral Fixation System because a packaging configuration failed leak tests, compromising product sterility.
Product
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2071-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2086-2013·2013-09-04
Alphatec Recalls Illico Ti Cannulated Polyaxial Screws Due to Manufacturing Defect
Alphatec Spine is recalling specific lots of Illico Ti Cannulated Polyaxial Screws because an off-center hole may prevent guide wires from passing through during surgery.
Product
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2089-2013·2013-09-04
McKesson Anesthesia-Rx Software Recall Due to System Interruption
McKesson Technologies is recalling 106 Anesthesia-Rx units because the system became temporarily unavailable during use.
Product
Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Defective Suction Wand
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands recalled by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2013·2013-09-04
DeRoyal Recalls Insufflation Tubing Sets Due to Materials Incompatibility
DeRoyal Industries is recalling specific lots of insufflation tubing sets because materials incompatibility could cause occlusion, potentially preventing gas flow during laparoscopic surgery.
Product
DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2046-2013·2013-09-04
Nidek NAVIS-EX Image Filing Software Recalled for Eye Image Mislabeling
Nidek Inc is recalling NAVIS-EX software because left eye images may be incorrectly saved as right eye images.
Product
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 software for ophthalmic images.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2053-2013·2013-09-04
Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.
Product
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2050-2013·2013-09-04
Sarken THC Test Kits Recalled for Inadequate Labeling and Instructions
Sarken, Inc. is recalling SARKEN STAT! 1-Panel Test Kits-THC because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.
Product
SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2078-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 8 units of trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2062-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox. Stem dia. 16 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2112-2013·2013-09-04
Becton Dickinson PrepStain Tecan US-II Recall for Incorrect Rack Setting
Becton Dickinson is recalling 890 PrepStain Tecan US-II instruments because a rack setting was incorrectly entered during routine maintenance.
Product
PrepStain Tecan US-II. For use in the screening and detection of cervical cancer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2107-2013·2013-09-04
SpineNet Bone Marrow Aspiration Needle Kit Recalled for Lack of FDA Clearance
SpineNet is recalling 100 units of Bone Marrow Aspiration Needle Kits because they were marketed for use with the SpineNet ACC device without FDA clearance or approval.
Product
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2082-2013·2013-09-04
Fresenius 2008 MeDS Pump Recalled for Venofer Dosage Accuracy Issues
Fresenius Medical Care is recalling 132 MeDS pumps used to administer Venofer during hemodialysis because the device may not meet dosage accuracy requirements.
Product
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2085-2013·2013-09-04
Life Technologies Recalls HSV-2 Primers Due to Amplification Failure
Life Technologies is recalling 15 kits of HSV-2 Primers because they failed to amplify HSV-2 DNA. The products were distributed in Delaware, Iowa, Minnesota, and North Carolina.
Product
HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2106-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Component Issue
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2060-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling four trial stems for a reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2052-2013·2013-09-04
Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect test results.
Product
SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2099-2013·2013-09-04
Stryker Recalls Asnis III Cannulated Screws Due to Incorrect Length
Stryker is recalling 23 units of Asnis III Cannulated Screws because the length of the device was reported to be incorrect.
Product
Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2045-2013·2013-09-04
Pipeline Embolization Device Recalled for Missing Contraindication Information
Micro Therapeutics Inc is recalling 62 Pipeline Embolization Devices because the instructions for use are missing specific contraindications regarding pre-existing stents and medication designations.
Product
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior…
Category
Medical Device
Distribution
19 states

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