Pet food and pet product recalls
1069 federal recalls on file. Federal recalls for dog and cat food, treats, chews, supplements, and pet products. Sourced from the FDA and USDA and translated into plain English.
- 2013-11-06FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation
Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical.
- 2013-11-06FDA-DeviceXoran Technologies, Inc.Class IIXoran MiniCAT CT Scanner ID ENT00001
Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate.
- 2013-11-06FDA-DeviceXoran Technologies, Inc.Class IIXoran MiniCAT00202
The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xorans specifications.
- 2013-11-06FDA-DeviceXoran Technologies, Inc.Class IIXoran Minicat00158
The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha
- 2013-11-06FDA-DeviceXoran Technologies, Inc.Class IIXoran Minicat00202
The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health ha
- 2013-11-06FDA-DeviceXoran Technologies, Inc.Class IIXoran MiniCAT CT Scanner
A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu
- 2013-11-06FDA-DeviceXoran Technologies, Inc.Class IIXoran Mini CT Scanner
A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evalu
- 2013-10-31CPSCLaRose Industries LLC, of Randolph, N.J.Snoopy Sno-Cone Machines Recalled by LaRose Industries Due to Risk of Mouth Injury
A brass rivet can fall out of the sno-cone machine's ice-shaving cylinder and into a sno-cone, posing a risk of injury to the mouth or the teeth.
- 2013-10-29CPSCBreathableBaby LLC, of Minnetonka, Minn.BreathableBaby Recalls Wearable Blanket Due to Choking Hazard
The zipper pull tabs and sliders can detach posing a choking hazard to infants.
- 2013-10-23FDA-DeviceGE Healthcare, LLCClass IIGE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
- 2013-10-23CPSCInfinitoy, Inc., San Mateo, Calif.Infinitoy Recalls Softimals Toy Sets Due to Choking and Aspiration Hazard
The plastic hats found on playset figures pose a choking/aspiration hazard for children.
- 2013-10-09FDA-DeviceAtrium Medical CorporationClass IIFlixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
- 2013-09-18FDA-DeviceLeica Microsystems (Schweiz) AgClass IISurgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
- 2013-09-18FDA-DeviceLeica Microsystems (Schweiz) AgClass IISurgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
The brake in the Z axis and/or brakes in the AB and C axes failed during installation.
- 2013-09-18FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
- 2013-09-18FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
- 2013-09-18FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
- 2013-09-18FDA-DeviceSiemens Healthcare Diagnostics, IncClass IIADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
- 2013-08-29CPSCBuild-A-Bear Workshop Inc., of St. Louis, Mo.Build-A-Bear Recalls Stuffed Animal Toy Due to Choking Hazard
The stuffed animal's eye can detach, posing a choking hazard to young children.
- 2013-08-21FDA-DrugWest-Ward Pharmaceutical Corp.Class IIBelladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724.
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
- 2013-08-21FDA-DrugPallimed SolutionsClass IIBuprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
- 2013-08-20CPSCApple Park LLC, of San FranciscoApple Park Recalls Children’s Loungewear Due to Violation of Federal Flammability Standard
The loungewear garments fail to meet children's sleepwear federal flammability standards which require sleepwear, including loungewear, to be either snug-fitting or flame resistant, posing a risk of burn injuries to children.
- 2013-08-15CPSCIKEA North America Services LLC, of Conshohocken, Pa.IKEA Recalls Junior Beds Due to Laceration Hazard
The metal rod connecting the guard rail to the bed frame can break in use, posing a laceration hazard.
- 2013-08-14FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IISonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali
- 2013-08-14FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IISonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali
- 2013-08-14FDA-DeviceStryker Instruments Div. of Stryker CorporationClass IISonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, plastic and reconstructive surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery.
A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. The issue is limited to 2 lots of the supplied component. The presence of the corrosion on the relay of the power supply board can potentially lead to a conduction defect which could cause the irrigation pump to stop working. The purpose of the irrigation pump is to supply sali
- 2013-08-07FDA-DeviceBecton Dickinson & Co.Class IIBD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,
In vitro diagnostic test kit may exhibit invalid internal negative control results.
- 2013-07-24FDA-DevicePaa Laboratories IncClass IIVarious types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of Un
- 2013-07-10FDA-DeviceSurgical Instrument Service And Savings, Inc.Class II- Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red) 5.5mm Ref. 7205669 Lot 122590, 122454, 122465, 122434, 122665 - AcromioBlaster Burr (Sage Green) 4.0mm Ref. 7205668 Lot 122590, 123270 - Acromionizer Bur, Barrel, (Mauve) 4.0mm Ref. 7205326 Lot 122609 - BoneCutter Blade, Full Radius, Series 3000 (Orange/Black) 5.5mm Ref. 7206010 Lot 122609 - CoolCut Bone Cutter (Blue/Orange) 3.8mm Ref. AR-8380BC Lot 122631 arthoscope - CoolCut Bone Cu
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
- 2013-07-03FDA-FoodBIMBO Bakeries USAClass IIHot Dog Buns 8 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
Due to the possible presence of metal fragments caused by a faulty manufacturing part at a North Carolina bakery
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