Pet food and pet product recalls
1082 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.
- 2015-10-18USDAClass IDo not eat Ranch Foods Direct meat products
Misbranding, Processing Defect
- 2015-09-30FDA-DeviceGE HealthcareClass IIPET Discovery ST 16
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
- 2015-09-30FDA-DeviceGE HealthcareClass IIPET Discovery LS
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
- 2015-09-30FDA-DeviceGE HealthcareClass IILightspeed 16 CT
Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
- 2015-09-30FDA-DeviceZien Medical Technologies, IncClass IIPenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.
- 2015-09-23FDA-DeviceRAYSEARCH LABORATORIES ABClass IIRadiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images
- 2015-09-16FDA-FoodJeni's Splendid Ice Creams LLCClass IIntelligentsia Black Cat Espresso Ice Cream Bucket, 347, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Intelligentsia Black Cat Espresso Ice Cream Indie Case, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, 18 containers per case, frozen. Intelligentsia Black Cat Espresso Ice Cream Indie, Jeni's Splendid Ice Creams, LLC, 6oz, plastic container, individually packed, frozen. Intelligentsia Black Cat Espresso Ice Cream Pint Case, 247, Jen
Product may be contaminated with Listeria monocytogenes.
- 2015-09-09FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual database lockup issue has been reported in the field-installed Ingenuity TF PET/MR systems.
- 2015-09-08USDAClass IThrow out Schrader Farms ground beef from September 2
Product Contamination
- 2015-09-02FDA-DeviceHardy DiagnosticsClass IIHardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
- 2015-09-02CPSCWan Le Xiang Bao Shang hang, of Yiwu, ChinaImagine Nation Books Recalls Pink Giraffe Animal Purse Due to Violation of Lead Paint Standard
The red paint on the zipper contains excessive levels of lead, violating the federal lead paint standard.
- 2015-08-26FDA-DeviceCordis CorporationClass IIRenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.
- 2015-08-26FDA-FoodH E B Grocery Company, LPClass IIHEB Bake Shop 8 Wheat Hot Dog Buns, Net Wt. 12 OZ, UPC: 041220191659
Products may contain cotton fibers.
- 2015-08-26FDA-FoodH E B Grocery Company, LPClass IIGood Bread 10" Coney, Net Wt. 18.2 OZ (516g), UPC: 041220181506; Good Bread 16 Hot Dog Enriched Buns Net Wt. 24 oz (680g) UPC: 04122018147
Products may contain cotton fibers.
- 2015-08-26FDA-FoodH E B Grocery Company, LPClass IIHill Country Fare 16 Hot Dog Buns Enriched Buns, Net Wt. 24 OZ (1 LB 8 OZ) (680g). UPC: 04122041611; Hill Country Fare 8 Hot Dog Buns Enriched Buns, Net Wt. 12 OZ (340g), UPC: 041220602018; HEB Bake Shop 8 White Hot Dog Buns Enriched Buns, Net Wt. 12 OZ, UPC: 041220839100
Products may contain cotton fibers.
- 2015-08-19FDA-DeviceStryker Howmedica Osteonics Corp.Class IITriathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.
Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.
- 2015-08-13CPSCAmerican SportWorks, of Roseland, La.American SportWorks Recalls Four-Wheel Off-Road Utility Vehicles Due to Risk of Injury
The throttle can fail to return to idle causing the rider to lose control, posing a risk of injury.
- 2015-08-13USDAClass IDiscard Kapowsin Meats whole hog barbecue products
Product Contamination
- 2015-08-05FDA-DeviceHardy DiagnosticsClass IIHardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
- 2015-08-05FDA-DeviceHardy DiagnosticsClass IIHardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
- 2015-08-05FDA-DeviceHardy DiagnosticsClass IIHardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
- 2015-08-05FDA-DeviceHardy DiagnosticsClass IIHardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
- 2015-08-05FDA-DeviceHardy DiagnosticsClass IIHardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance.
- 2015-07-29FDA-DeviceMyoscience IncClass IIiovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected si
The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Instead of indicating the correct expiration or 2015-12. the labels were incorrectly labeled 2016-05.
- 2015-07-29FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIGEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
- 2015-07-29FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIGEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
- 2015-07-29FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIGEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
- 2015-07-29FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIGEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
- 2015-07-29FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIGEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
- 2015-07-29FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIGEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
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