Archive
530 recalls were announced in September 2013.
Of the 530 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.
Which agencies issued them
Churchill Medical Systems is recalling 13,100 Vygon 14 Microbore Extension Sets because the tubing may disconnect from the male luers.
Philips is recalling Brilliance CT scanners because the footswitch cover may impinge on the footswitch, causing the patient support to move unexpectedly.
Smith & Nephew is recalling RAPTORMITE 3.7 mm PLLA suture anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling OSTEORAPTOR 2.3 mm suture anchors because pinholes in primary pouches may breach the sterile barrier.
Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.
GE Healthcare is recalling 636 CARESCAPE Monitor B850 units due to a software issue that may cause incorrect alarm priorities when managed via the iCentral network.
GE Healthcare is recalling CARESCAPE Monitor B650 units due to potential issues. No injuries or illnesses have been reported.
Smith & Nephew is recalling OSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling BIORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Instrumentation Laboratory is recalling 185 ACL TOP 700 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.
Smith & Nephew is recalling TWINFIX Ultra HA 4.5 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Smith & Nephew is recalling 1,735 Bioraptor 2.9 mm suture anchors because pinholes in the primary pouches may breach the sterile barrier.
Smith & Nephew is recalling OSTOSTEORAPTOR 2.9 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
Spine Smith Holdings is recalling 32 VisuALIF PEEK blocks because they may be marked as Medium when they are actually Small.
Biomet 3i is recalling 215 Osseotite 2 Certain Prevail dental implants because some units lack the internal hex and thread features required for proper prosthetic attachment.
Cincinnati Sub-Zero is recalling Blanketrol III manuals because text was incorrectly added back, contradicting the device's approved intended use.
Implantech Associates Inc is voluntarily recalling 8 units of Terino Square Chin-Style II-Medium implants because they do not meet dimensional requirements.
GE Healthcare is recalling four Discovery IGS 730 Cardiovascular X-Ray Imaging Systems due to a software error that may prevent the system from booting.
Assuramed is recalling Hemoccult II SENSA elite test kits because they may have been stored at temperatures outside required conditions.
Assuramed is recalling ProTime and ProTime3 cuvettes because they may have been stored at incorrect temperatures, potentially affecting test accuracy.
Camlog USA is recalling three units of CONELOG Titanbasis CAD/CAM titanium base abutments because the product was not cleared for sale or use in the United States.
Assuramed is recalling DiaScreen Liquid Urine Controls because they may have been stored at temperatures outside required conditions.
Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg tablets because the bottles display an incorrect expiration date of 05/2017 instead of 10/2016.
Zeppessis Reprocessing is recalling reprocessed single-use manifolds for Stryker Neptune systems because they lack FDA 510(k) clearance and a validated cleaning protocol.
Camlog USA is recalling six dental implant abutments because they were not cleared for sale or use in the United States.
New Dream Team is recalling fresh sweet and Thai basil from Hawaii after state testing found pesticides not allowed on the crop.
Boehringer Ingelheim is recalling SPIRIVA HandiHaler capsules due to potential foreign particles in the active pharmaceutical ingredient.
Procter & Gamble is recalling Vicks NyQuil Cold and Flu Nighttime Relief Liquid Twin Packs because the outer wrap incorrectly identifies color additives.
Biomet 3i, LLC is recalling 178 Osseotite Parallel Walled dental implants because some units are missing the internal hex and internal thread features.
Camlog USA is recalling one unit of a CONELOG Titanium Base dental implant abutment because it was not cleared for sale or use in the United States.
Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel because some syringes contain a different material than the labeled shade.
Sonogage Inc is recalling 564 EyeScan A-Scan Biometers because the firm lacked FDA registration and 510(k) clearance for the device.
Access Scientific is recalling 160 units of the POWERWAND Safety Introducer with Extended Dwell Catheter because the product is mislabeled.
Camlog USA is recalling two units of CONELOG Titanium Base CC dental implant abutments because the product was not cleared for sale or use in the United States.
Smith & Nephew is recalling Bioraptor 2.9 mm Suture Anchors because pinholes in the primary pouches may breach the sterile barrier.
Integra LifeSciences is recalling specific lots of Cranial Access Kits because the sterile package seal may become compromised during shipping.
3M is voluntarily recalling specific lots of Scotchcast Wet or Dry Cast Padding because the material does not consistently repel water, which may prolong cast drying times.
King Systems Corp. is recalling King LT-D Oropharyngeal Airways because size 5 units were packaged in pouches labeled as size 2.5.
Novartis Consumer Health is recalling Benefiber fiber supplement bottles because the lot number and expiration date may be illegible on the outer packaging.
Novartis Consumer Health is recalling specific lots of Benefiber Wild Berry Chewables because the lot number and expiration date may be illegible on the outer packaging.
Novartis Consumer Health is recalling 419,040 units of Benefiber chewable tablets because the lot number and expiration date may be illegible on the outer plastic bottle packaging.
Novartis Consumer Health is recalling specific lots of Benefibre Orange Creme Chewables because the lot number and expiration date may be illegible on the packaging.
Watson Laboratories is recalling 875 bottles of Hydrocodone Bitartrate and Acetaminophen Tablets because defective bottles may have improperly seated tamper-evident seals.
Novartis Consumer Health is recalling specific lots of Benefiber Orange Creme Chewables because the lot number and expiration date may be illegible on the outer plastic bottle packaging.
Mazda is recalling 2009-2013 Mazda6 vehicles because door latch mounting screws may become loose, potentially allowing doors to open while driving.
General Motors is recalling 2013-2014 Chevrolet Cruze vehicles with manual transmissions because the right front half shaft may fracture, potentially causing loss of power or unexpected movement.
Lakota is recalling 2013-2014 trailers where the refrigerator combustion system vents into the interior, posing an asphyxiation risk.
Volkswagen is recalling 2013-2014 Audi S6 and S7 vehicles because a fuel line may leak, posing a fire risk if exposed to an ignition source.
Cargo Craft is recalling 2006-2013 cargo trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.
Volkswagen is recalling 1,120 Audi A8 and S8 vehicles because the sunroof glass panel may shatter, posing an injury risk.
New Flyer is recalling 57 D40I transit buses from 2004-2006 because electrical components may conduct electricity and cause a fire.
Coach and Equipment is recalling 2009-2010 Metro-Lite and Phoenix buses equipped with optional power doors due to a potential circuit board overheating issue that could cause a vehicle fire.
New Flyer is recalling 2012 XN40 transit buses because cracks in certain bicycle racks may cause parts to fall off, creating a road hazard.
Mitsubishi is recalling 2008-2013 Lancer Evolution vehicles because the clutch master cylinder can fail, increasing the risk of a crash.
North American Bus Industries is recalling specific transit buses because a battery equalizer component may conduct electricity and cause a fire.
Honda is recalling 2003-2004 Odyssey and 2003 Acura MDX vehicles because electrical noise may cause air bags to deploy unexpectedly, increasing injury risk.
Frigidaire is recalling about 14,000 Professional blenders because the blade shaft assembly can break during use, posing a laceration hazard.
DENY Designs is recalling 82 Baroque and Quatrefoil Magnet Boards because the steel cover can separate from the wood backing and fall. No injuries were reported.
Shimano American is recalling approximately 6,600 disc brake calipers in the U.S. because they can fail, posing a collision hazard. No injuries have been reported.
The Land of Nod is recalling specific iron bed frames due to an entrapment hazard for young children. One incident of entrapment was reported without injury.
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.
Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.
Beacon Hill Medical Pharmacy is recalling Estradiol Cypionate/Progesterone/Testosterone Cypionate injections due to FDA inspectional findings regarding sterility assurance.
Wellness Pharmacy is recalling 590 vials of Magnesium Sulfate Hepta 50% PF due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.
Beacon Hill Medical Pharmacy is recalling compounded cyanocobalamin injections because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling B-Complex/Lido/B-12 injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling DMPS 50mg/ml Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling B-12/Lidocaine 25/10mg/mL injections because FDA inspections raised concerns about sterility assurance and quality control.
Beacon Hill Medical Pharmacy is recalling Calcium EDTA 300 mg/mL Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling Bi-Mix Phentolamine/Papaverine injectable products because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Lipo-Plex Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling PUMICE/LIDOCAINE HCL 1.5%/1% Injection Suspensions because FDA inspections raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Chromium 4 mcg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling Freamine III Alt 8.5% Injectable due to sterility assurance concerns identified during an FDA inspection.
Beacon Hill Medical Pharmacy is recalling Oxytocin 10 Units/mL because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling Selenium 400 mcg/mL injectable because FDA inspections raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Alprostadil injection due to FDA inspectional findings regarding quality control and sterility assurance.
Wellness Pharmacy is recalling RL Glutathione 100 mg/mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Beacon Hill Medical Pharmacy is recalling Ascorbic Acid 500 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling Furosemide 10 mg/mL injectable products because FDA inspectional findings raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Multitrace-5 Injectable because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Beacon Hill Medical Pharmacy is recalling Glutathione 200 mg/mL injection solution because FDA inspections raised concerns about sterility assurance and quality control.
South Coast Specialty Compounding is recalling Methylcobalamin Injection 5 mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in California and Indiana.
Beacon Hill Medical Pharmacy is recalling compounded Triamcinolone Acetonide injections because FDA inspections raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling Potassium Chloride 2 mEq/mL Injectable because FDA inspectional findings raised concerns about sterility assurance and quality control procedures.
Spartan Motors is recalling 2011-2013 Transit Bus Chassis Cabs because front sway bar fasteners may loosen, potentially damaging brake lines and increasing crash risk.
Beacon Hill Medical Pharmacy is recalling compounded progesterone and testosterone injections due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling B-12 Rejuv 25 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.
Spartan Motors is recalling 75 model year 2011-2013 Transit Bus Chassis Cab vehicles because front suspension control arms may fracture without warning, increasing crash risk.
Covidien LLC is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
FDA is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.
Beacon Hill Medical Pharmacy is recalling Sodium Phosphate Monobasic/Water for Injection 10% because FDA inspections raised concerns about sterility assurance and quality control.
Wellness Pharmacy is recalling 1,355 vials of Dexpanthenol 250 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.
Beacon Hill Medical Pharmacy is recalling Arginine (R-Gene) 100 mg/mL injectable because FDA inspectional findings raised concerns about sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded sterile injection solutions due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Zinc Sulfate 1 mg/ml Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
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