Pet food and pet product recalls
1058 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.
- 2017-10-19CPSCKids Preferred LLC., of East Windsor, N.J.Kids Preferred Recalls Wind-Up Musical Toys Due to Choking Hazard
The metal post and/or handle of the wind-up mechanism can detach, posing a choking hazard to young children.
- 2017-09-17USDAClass IGerman Sausage Haus, LLC, Retira Productos De Carne Debido A Una Posible Desviacin En El Procesamiento Y Contaminacin De Enterotoxina Estafiloccica
Product Contamination
- 2017-09-06FDA-DeviceOptovue, Inc.Class IIiVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
- 2017-09-06FDA-DeviceOptovue, Inc.Class IIiFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation o
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
- 2017-09-06FDA-DeviceOptovue, Inc.Class IIiVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for t
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
- 2017-08-31CPSCHallmark Marketing Company LLC, of Kansas City, Mo.Hallmark Recalls Plush Baby Stacking Toys Due to Choking Hazard
The toys have fabric hats and bows that can detach, posing a choking hazard.
- 2017-08-30FDA-FoodGrandma's HerbsClass III"Because They Work" GRANDMA'S HERBS CHOLESTEROL SUPPORT, Dietary Supplement, 100 Capsules 480 mg. Packaging: PET plastic bottles, UPC# 714938 00046
Grandmas Herbs Cholesterol has undeclared soy lecithin.
- 2017-08-23FDA-DeviceGE Medical Systems, LLCClass IISigna PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appro
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- 2017-08-23FDA-DrugGlobal Marketing Enterprises, Inc.Class IICaffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076
Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
- 2017-08-09FDA-DeviceHologic, IncClass IITomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.
- 2017-08-03CPSCBelle Investment Corporation, of Irvine, Calif.Richie House Children's Robes Recalled by Belle Investment Due to Violation of Federal Flammability Standard; Sold Exclusively at Amazon.com
The children's robes fail to meet federal flammability standards for children's sleepwear, posing a risk of burn injuries to children.
- 2017-07-26FDA-DeviceSiemens Medical Solutions USA, IncClass IIArtis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee sys
Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
- 2017-07-26FDA-FoodUnited Natural Foods, Inc.Class IFat Cat Purry-Purry Sauce, Net Weight: 5 oz (141g)
Undeclared allergen: Peanuts
- 2017-07-19FDA-FoodCorrectional Industries Food FactoryClass IIIItem 10309 - WHITE WHOLE WHEAT HOT DOG BUNS, BULK>192CT(24@8EA)/CS, Frozen, Net wt. 27.28 lbs per case.
Product is recalled because it was made with water contaminated with chemicals perfluorooctanoic acid (PFOA) and perluorooctanesulfonic acid (PFOS). The observed PFOS and PFOA levels exceed EPA's 2016 combined Lifetime Health Advisory levels for drinking water (70 parts per trillion [ppt]).
- 2017-06-07FDA-DeviceZimmer Biomet, Inc.Class IIModular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. This system is intended for primary and revision total s
Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.
- 2017-06-07CPSCMadison Mill Inc., of Ashland City, Tenn.Madison Mill Recalls Safety Gates Due to Entrapment and Strangulation Hazards
A young child's neck can fit into the "V" shaped opening along the top edge of the gate, posing entrapment and strangulation hazards to young children. Also, young children can pass under the gate allowing access to restricted areas, such as stairs.
- 2017-06-06CPSCArctic Cat Inc., of Thief River Falls, Minn.Arctic Cat Recalls Snowmobiles Due to Impact Hazard (Recall Alert)
The snowmobile drive clutch can fracture and fragments can escape the snowmobile shielding, posing an impact hazard.
- 2017-05-19USDAClass IIJohn Morrell and Co. Retira Del Mercado Productos De Salchichas "Hot Dogs" De Carne De Res ("Franks") Por Posible Contaminación Con Material Extraño
Product Contamination
- 2017-05-17CPSCDouglas Company Inc., of Keene, N.H.Douglas Recalls Plush Toys Due to Choking Hazard
The plastic eyes on the plush toys can detach, posing a choking hazard.
- 2017-05-03FDA-DeviceBecton Dickinson & Co.Class IIIBBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.
- 2017-05-03FDA-FoodFresh Express IncorpatedClass IIOrganic Marketside Spring Mix, net Wt. 5 oz. (142g) packed in rigid plastic container, UPC code 6 8113132897 5.
Foreign animal matter was allegedly found in a single container of the salad.
- 2017-05-03FDA-FoodValley Bakery Wholesalers IncClass IHot Dog Buns, Valley Bakery, Rock Valley, IA, 8 count. UPC 290206803004, packaged in clear plastic bags
Bakery products which contain an ingredient which contain egg do not declare egg on the label
- 2017-04-12FDA-DeviceSiemens Healthcare Diagnostics, IncClass IISiemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
- 2017-04-12FDA-DeviceSiemens Healthcare Diagnostics, IncClass IISiemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patie
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
- 2017-04-12FDA-DeviceSiemens Healthcare Diagnostics, IncClass IISiemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur¿ BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur¿, ADVIA Centaur¿ XP, and ADVIA Centaur¿ XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patien
Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
- 2017-04-05FDA-DeviceBaxter Healthcare CorporationClass IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
- 2017-03-08FDA-DeviceSiemens Healthcare Diagnostics, IncClass IISiemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
- 2017-03-08FDA-DeviceSiemens Healthcare Diagnostics, IncClass IISiemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
- 2017-03-08FDA-DeviceSiemens Healthcare Diagnostics, IncClass IISiemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
- 2017-03-01FDA-FoodPenn Herb Company, Ltd.Class IIINature's Wonderland Sinus & Lung Care, 60 VCaps (Capsules), PET bottle
There was a mix-up with ingredients used. The product is an herbal blend consisting of 7 different herbs. The blend calls for Ginger Root; however, Ginkgo Leaves was accidentally added.
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