The Recall Desk

Archive

April 2018 recalls

622 recalls were announced in April 2018.

What the numbers show

Critical
19
Severe
146
High
321
Moderate
110
Low
26

Of the 622 recalls this month scored against our rubric, 3% are Critical, 23% are Severe.

Which agencies issued them

501–600 of 622

  • HighFDA (Food)·F-0973-2018·2018-04-04

    J.M. Rosen's Cheesecake Recalled Due to Foreign Object Contamination

    J.M. Rosen's is recalling New York Traditional Cheesecake after a retail employee found a small rubber object in the product.

    Product
    J.M. Rosen's Cheesecake - New York Traditional; 6 - Unit- 4/46 oz in a case box; Product #56378 UPC 6 93892 99462 7; INGREDIENTS: Cream Cheese (Pasteurized Nonfat Milk, and Milkfat~ Whey Protein Concentrate, Cheese Culture. Salt, Whey, Stabilizers (Xanthan Gum, and/or…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0962-2018·2018-04-04

    Griffith Foods Recalls Toasted Italian Herbs Due to Salmonella Risk

    Griffith Foods is voluntarily recalling Toasted Italian Herbs because a supplier recalled Autolyzed Yeast Powder due to Salmonella presence.

    Product
    Product Name Lot Number or ID Toasted Italian Herbs 661126
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1212-2018·2018-04-04

    Konica Minolta Sonimage HS1 Ultrasound AC Adapter Recall for Fire Risk

    Konica Minolta is recalling 88 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage that may cause smoke emission.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1248-2018·2018-04-04

    Stryker Recalls Advanced Cement Mixing Kits Due to Sterility Concerns

    Stryker is recalling 1,542 Advanced Cement Mixing Kits because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1228-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed to meet clinical survivorship criteria.

    Product
    ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2018·2018-04-04

    Stryker Recalls 30 Revolution 90 Degree Tibial Nozzles for Sterility Issues

    Stryker is recalling 30 units of the Revolution 90 Degree Tibial Nozzle because bioburden levels exceeded acceptable rates, posing a sterility risk.

    Product
    Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1192-2018·2018-04-04

    Zimmer Biomet Recalls Mismatched Hip Implant Packages Due to Sizing Error

    Zimmer Biomet is recalling 24 hip implant packages labeled as size 7.5 Extended Offset Reduced Neck length that actually contained Size 4 Standard Reduced Neck length implants.

    Product
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-0960-2018·2018-04-04

    Griffith Foods Recalls Whiskey & Cola Seasoning Due to Salmonella Risk

    Griffith Foods is voluntarily recalling Whiskey & Cola Type Flavored Seasoning because a supplier recalled Autolyzed Yeast Powder for Salmonella.

    Product
    Product Name Lot Number or ID Whiskey & Cola Type Flavored Seasoning 660373
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1223-2018·2018-04-04

    Cook Vital-Port Vascular Access System Recall for Needle-Related Septum Damage

    Cook Vascular Inc. is recalling Vital-Port Vascular Access Systems because the included non-coring needle may cut or dislodge material from the device septum during initial implant.

    Product
    Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1208-2018·2018-04-04

    Puritan Bennett 980 Ventilator Batteries Recalled for Firmware Defect

    FDA is recalling 15,885 rechargeable lithium-ion batteries for Puritan Bennett 980 ventilators due to incorrect firmware that may prevent full charging.

    Product
    Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2018·2018-04-04

    ConMed Recalls Mini Infant Radiotranslucent Electrodes Due to Adhesive Defect

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on the contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0957-2018·2018-04-04

    Newly Weds Foods Recalls Roast Chicken Marinade Due to Salmonella Risk

    Newly Weds Foods is recalling Roast Chicken Marinade because a supplier recalled yeast containing salmonella. The product was distributed in Pennsylvania, Illinois, Arkansas, and Kansas.

    Product
    Roast Chicken Marinade SE746125 and SE746126, 50# Bags
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1237-2018·2018-04-04

    Signia Power Handle Recalled for Shutting Down During Surgical Use

    Covidien LLC is recalling 2,121 Signia Power Handles because they reportedly shut down during use. The devices are used in various surgical procedures.

    Product
    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0984-2018·2018-04-04

    Schwartz Brothers Bakery Recalls Cinnamon Rolls for Undeclared Egg

    Schwartz Brothers Bakery is recalling 106 units of Gourmet Cream Cheese Cinnamon Rolls due to undeclared egg. The product was distributed in Washington.

    Product
    Gourmet Cream Cheese Cinnamon Rolls, packaged in a 16 oz. plastic clam shell container and sold under the Schwartz Brothers Bakery brand. The product UPC is 7 17887 65082 1. The product is read in parts: "***GOURMET CREAM CHEESE CINNAMON ROLLS***NET WT. 16 OZ***Produced By…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1250-2018·2018-04-04

    Stryker AutoPlex Bone Cement Recalled for Sterility Assurance Issues

    Stryker is recalling AutoPlex bone cement systems because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1195-2018·2018-04-04

    Roche Recalls cobas MRSA/SA Nucleic Acid Tests for Decreased Performance

    Roche Molecular Systems is recalling cobas MRSA/SA tests worldwide due to decreased performance that may lead to screening failures and potential infection spread.

    Product
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1245-2018·2018-04-04

    Stryker Recalls Femoral Canal Pressurizers Due to Sterility Assurance Issues

    Stryker is recalling specific lots of Femoral Canal Pressurizers because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1219-2018·2018-04-04

    DePuy Sigma HP Cemented Trochlear Implants Recalled for Elevated Revision Rates

    DePuy Orthopaedics is recalling specific Sigma HP Cemented Trochlear Implants due to elevated revision rates identified during post-market surveillance.

    Product
    (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2018·2018-04-04

    Konica Minolta Sonimage HS1 Ultrasound Kit AC Adapter Recall

    Konica Minolta is recalling 17 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage and smoke emission.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1255-2018·2018-04-04

    Stryker Recalls Intramedullary Brushes Due to Sterility Assurance Failure

    Stryker is recalling 320 Intramedullary Brushes because bioburden levels exceeded acceptable rates, compromising sterility assurance.

    Product
    Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1186-2018·2018-04-04

    Cook Inc. Recalls IVF Intratubal Transfer Sets Due to Quality Testing Gaps

    Cook Inc. is recalling specific lots of Echosight Jansen-Anderson Intratubal Transfer Sets because they were distributed without completed quality testing, posing a risk of nonviable embryos.

    Product
    Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2018·2018-04-04

    Arrow Endurance Peripheral Catheter Systems Recalled for Missing Safety Latch

    Arrow International is recalling specific lots of Endurance Extended Dwell Peripheral Catheter Systems because they may be missing a safety latch designed to prevent sharps injuries.

    Product
    ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1231-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2018·2018-04-04

    Deerfield Imaging Recalls ORT200 Operating Room Tables Due to Locking Mechanism Failure

    Deerfield Imaging is recalling 17 IMRIS ORT200 operating room tables because their rotational locking mechanisms fail to operate, preventing the table from changing between locked and unlocked states.

    Product
    IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1259-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Screws

    Zimmer Biomet is recalling ACE Trochanteric Nail System screws because a device performance review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SCREW 70MM STERILE ATN AR SCREW 75MM STERILE ATN AR SCREW 80MM STERILE ATN AR SCREW 85MM STERILE ATN AR SCREW 90MM STERILE ATN AR SCREW 95MM STERILE ATN AR SCREW 100MM STERILE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0987-2018·2018-04-04

    Marsee Baking Variety Pack Cookies Recalled for Undeclared Coconut Allergen

    Pinks Bakery Seattle is recalling Marsee Baking brand Variety Pack cookies because coconut is listed in ingredients but not declared in the allergen statement.

    Product
    Variety Pack, Marsee Baking brand, eight 3.2oz cookies individually wrapped in plastic (Grab and Go) or unwrapped and placed in a paperboard box (Fresh Case). Box contains two Hippie Cookies, and 6 other cookies. Hippie Cookies product labeled in part…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1214-2018·2018-04-04

    Konica Minolta Recalls Sonimage HS1 Ultrasound Kit AC Adapters

    Konica Minolta is recalling 30 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage and smoke emission.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1266-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT300 Operating Room Tables Due to Drift Risk

    Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1267-2018·2018-04-04

    Medica EasyCAL HbA1c Calibrator Recalled for Potential Result Deviations

    Medica Corporation is recalling EasyCAL HbA1c Calibrator kits because patient results may deviate up to 20 percent.

    Product
    EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1265-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS T2X Operating Room Tables

    Deerfield Imaging is recalling 14 IMRIS T2X Operating Room Tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0965-2018·2018-04-04

    Griffith Foods Recalls Premix Roasted Chicken Due to Salmonella Risk

    Griffith Foods is voluntarily recalling Premix Roasted Chicken because a supplier recalled Autolyzed Yeast Powder for Salmonella.

    Product
    Product Name Lot Number or ID Premix Roasted Chicken 1258969 660025
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0961-2018·2018-04-04

    Griffith Foods Pan Roast Brown Gravy Mix Recalled for Salmonella Risk

    Griffith Foods is voluntarily recalling Pan Roast Brown Gravy Mix because a supplier recalled Autolyzed Yeast Powder due to Salmonella.

    Product
    Product Name Lot Number or ID Pan Roast Brown Gravy Mix 659281, 659282, 659283, 659284, 659285, 659286 Pan Roast Brown Gravy Mix 661090, 661089, 661091
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1246-2018·2018-04-04

    Stryker InterPulse Handpieces Recalled for Sterility Assurance Issues

    Stryker is recalling InterPulse Handpieces because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

    Product
    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1240-2018·2018-04-04

    Zimmer Biomet Recalls Persona Partial Knee Spacer Blocks

    Zimmer Biomet is recalling Persona Partial Knee Spacer Blocks because they may feel tight during trialing or appear loose in extension.

    Product
    Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2018·2018-04-04

    Siemens Dimension Vista LOCI 8 Calibrator Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling the Dimension Vista LOCI 8 Calibrator due to increased failed calibration events and negative bias in Estradiol assays.

    Product
    Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2018·2018-04-04

    St. Jude Medical Recalls Proclaim DRG Implantable Pulse Generators

    St. Jude Medical is recalling 17 Proclaim DRG Implantable Pulse Generators due to error messages during routine checks and transient overstimulation causing patient discomfort.

    Product
    Proclaim DRG Implantable Pulse Generator, Model Number 3664
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1176-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1218-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT300 Operating Room Tables

    Deerfield Imaging is recalling 13 IMRIS ORT300 operating room tables because their rotational locking mechanisms may fail to operate, preventing the table from changing between locked and unlocked states.

    Product
    IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1263-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT100 Operating Room Tables

    Deerfield Imaging is recalling 26 IMRIS ORT100 operating room tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1264-2018·2018-04-04

    Deerfield Imaging Recalls IMRIS ORT200 Operating Room Tables for Drift Risk

    Deerfield Imaging is recalling 17 IMRIS ORT200 operating room tables because they may drift during use, potentially causing unintended movement.

    Product
    IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0976-2018·2018-04-04

    IDLife Chocolate and Almond Snack Bars Recalled for Undeclared Peanuts

    IDLife, LLC is recalling IDLife Snack Bar Chocolate and Almond because the product contains almonds but does not declare the presence of peanuts.

    Product
    IDLife Snack Bar Chocolate and Almond (SKU 16-0011) Organic, non-GMO and gluten-free snack bar. Individually wrapped bars, packaged 10 to a box
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1188-2018·2018-04-04

    Cook Inc. Recalls IVF Embryo Transfer Sets Due to Quality Testing Gaps

    Cook Inc. is recalling specific lots of IVF embryo transfer sets and catheters because they were distributed without completed quality testing, posing a risk of nonviable gametes or embryos.

    Product
    1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2018·2018-04-04

    Roche cobas e 601 Immunoassay Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.

    Product
    c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System After Failed Performance Review

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0967-2018·2018-04-04

    Griffith Foods Recalls Au Jus Seasoning Due to Salmonella Risk

    Griffith Foods is voluntarily recalling specific lots of Au Jus Seasoning Reduced Sodium because a supplier recalled Autolyzed Yeast Powder for Salmonella.

    Product
    Product Name Lot Number or ID Au Jus Seasoning Reduced Sodium 659868, 660660, 660661, 660662, 660663 Au Jus Seasoning Reduced Sodium 656387, 656388, 659864, 659865, 659866, 659867
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1180-2018·2018-04-04

    BD Vacutainer Blood Collection Tubes Recalled for Residual Blood on Stopper

    Becton Dickinson is recalling 1,976,000 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tubes because increased residual blood was found on the top of the stopper well after venipuncture.

    Product
    BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0966-2018·2018-04-04

    Griffith Foods Recalls Salt & Vinegar Seasoning Due to Salmonella Risk

    Griffith Foods is voluntarily recalling Salt & Vinegar Seasoning because a supplier recalled Autolyzed Yeast Powder due to Salmonella presence.

    Product
    Product Name Lot Number or ID Salt & Vinegar Seasoning - 50 LB CS 662977
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1229-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System because a device performance review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG STRL TROCH NAIL ST 11X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2018·2018-04-04

    Stryker iVAS System Kits Recalled for Sterility Assurance Issues

    Stryker is recalling 504 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

    Product
    1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1258-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Defect

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause device failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1216-2018·2018-04-04

    Stryker Recalls Thoracic Pedicle Feelers Due to Potential Tip Breakage

    Stryker is voluntarily recalling 28 Thoracic Pedicle Feelers because machine settings caused material degradation, creating a risk that the instrument tip may break.

    Product
    The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1181-2018·2018-04-04

    Ohmeda Medical Recalls Rotating IV Poles Due to Fall Risk

    Ohmeda Medical is recalling 1,179 rotating IV poles because they may fall, posing a risk of injury to patients, bystanders, or operators.

    Product
    Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 92 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a Device Performance Review failed clinical analysis for survivorship.

    Product
    ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STERILE ATN LAG SCREW 95MM STERILE ATN LAG SCREW 100MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2018·2018-04-04

    Inova Diagnostics Recalls QUANTA-Lyser 240 EIA Due to Power Supply Defect

    Inova Diagnostics is recalling one QUANTA-Lyser 240 EIA instrument because a defective power supply may cause loss of protective grounding.

    Product
    QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0986-2018·2018-04-04

    Marsee Baking Hippie Cookies Recalled for Undeclared Coconut Allergen

    Pinks Bakery Seattle, Inc. is recalling Marsee Baking brand Hippie Cookies because coconut is listed in the ingredients but not declared in the 'Contains' statement. The product was distributed in Oregon and Washington.

    Product
    Hippie Cookie, Marsee Baking brand, six 3.2oz cookies individually wrapped in plastic (Grab and Go) or six unwrapped, bulk packed on baking paper and placed in a paperboard box (Fresh Case). Product labeled in part, "Ingredients:***Coconut***Allergens: Contains Eggs, Tree…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1185-2018·2018-04-04

    Cook Inc. Recalls IVF Embryo Transfer Syringes Due to Quality Testing Gaps

    Cook Inc. is recalling specific lots of Norm-Ject Tuberkulin Syringes used for IVF embryo transfer because they were distributed without completed quality testing.

    Product
    Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0952-2018·2018-04-04

    Mondelez Recalls Sour Patch Kids Due to Peanut Shell Remnants

    Mondelez Global LLC is recalling 1.9 lb bags of Sour Patch Kids because peanut shell remnants were found in two containers. The product is not labeled as containing peanuts.

    Product
    Sour Patch Kids, 1.9 lb bag
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1196-2018·2018-04-04

    Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates

    Zimmer Biomet is recalling AIM Tibial Nails because the surgical revision rate exceeded acceptance criteria in a clinical analysis.

    Product
    AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1182-2018·2018-04-04

    Madison Polymeric Engineering Recalls First Step Flexible Endoscope Bedside Pre-Clean Kit

    Madison Polymeric Engineering is recalling 285 cases of the First Step Flexible Endoscope Bedside Pre-Clean Kit because affected lots may have exceeded microbial limits.

    Product
    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1213-2018·2018-04-04

    Konica Minolta Sonimage HS1 Ultrasound Kit AC Adapter Recall

    Konica Minolta is recalling 85 Sonimage HS1 Ultrasound Kit AC adapters due to a risk of circuit board breakage and smoke emission.

    Product
    Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-1273-2018·2018-04-04

    Mesa Laboratories Recalls ProSpore Biological Indicators Due to Concentration Defect

    Mesa Laboratories is recalling specific lots of ProSpore Biological Indicators because the concentration of bromocresol purple does not conform to specification.

    Product
    ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1202-2018·2018-04-04

    Johnson & Johnson Recalls COACH Self-Adhering Sports Wraps for Latex Labeling Error

    Johnson & Johnson is recalling COACH Self-Adhering Sports Wraps because the label incorrectly states they are not made with natural rubber latex, though latex was used in early manufacturing.

    Product
    COACH¿ Self-Adhering Sports Wrap (size: 3in)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0609-2018·2018-04-04

    Bracco Recalls E-Z-Paste Barium Sulfate Due to Preservative Failure

    Bracco Diagnostics is recalling E-Z-Paste Barium Sulfate Esophageal Cream because one lot failed stability testing for the preservative methylparaben.

    Product
    E-Z-PASTE — E-Z-PASTE (BARIUM SULFATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1203-2018·2018-04-04

    Johnson & Johnson Recalls First Aid Wraps Due to Latex Labeling Error

    Johnson & Johnson is recalling select first aid wraps because they were labeled as latex-free but used natural latex in early manufacturing.

    Product
    Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1193-2018·2018-04-04

    Teleflex Visistat 35 Skin Closure Devices Recalled for Labeling Error

    Teleflex Medical is recalling Visistat 35 skin closure devices because some boxes are mislabeled as Wide when they contain Regular devices.

    Product
    Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1183-2018·2018-04-04

    Quidel Recalls Sofia 2 Analyzers Due to Calibration Error

    Quidel is recalling 482 Sofia 2 Analyzers because a manufacturing error may cause calibration failure or incorrect test results.

    Product
    Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1238-2018·2018-04-04

    Zimmer Biomet Recalls Partial Knee Spacer Block Instruments

    Zimmer Biomet is recalling specific Persona Partial Knee spacer block instruments because they do not fit in the alignment tower instrument or handle.

    Product
    Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1269-2018·2018-04-04

    Roche Modular E 170 Analyzer Recalled for Questionable Results

    Roche Diagnostics is recalling Modular E 170 Analyzers because using 13 mm sample tubes without adapters may cause questionable test results.

    Product
    Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001, 05023599001, 05023572001, 03739040001 & 03023109973.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2018·2018-04-04

    Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots

    Zimmer Dental Inc is recalling Tapered Screw-Vent MTX dental implants because two lots with different thread diameters were commingled and may be mislabeled.

    Product
    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0612-2018·2018-04-04

    Akorn Recalls 24-Hour Oral Care Kits Due to Low Chlorhexidine Levels

    Akorn, Inc. is recalling 24-Hour Oral Care q2 Kits because the chlorhexidine gluconate oral rinse contained in some units had low potency levels.

    Product
    24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2018·2018-04-04

    Zimmer Biomet Recalls Coonrad/Morrey Elbow Implant Humeral Assemblies

    Zimmer Biomet is recalling nine Coonrad/Morrey Elbow Implant humeral assemblies because they are missing required humeral bushing components.

    Product
    Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1204-2018·2018-04-04

    Johnson & Johnson Recalls Select First Aid Wraps Due to Latex Labeling Error

    Johnson & Johnson is voluntarily recalling select first aid wraps because the label incorrectly states they are not made with natural rubber latex.

    Product
    Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1205-2018·2018-04-04

    Johnson & Johnson Recalls First Aid Wraps Due to Latex Labeling Error

    Johnson & Johnson is voluntarily recalling select first aid wraps because the 'not made with natural rubber latex' label is inaccurate.

    Product
    Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1199-2018·2018-04-04

    GE Healthcare Recalls Datex-Ohmeda Anesthetic Cassettes for Quality Control Issues

    GE Healthcare is recalling two Datex-Ohmeda AISYS CS2 Aladin2 cassettes because they were shipped without proper evaluation and may be nonconforming.

    Product
    DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1173-2018·2018-04-04

    Biomet Recalls Orthopedic Implants Due to Screw Hole Mismatch

    Biomet is recalling 634 Zimmer Biomet Comprehensive Segmental Revision System implants because a screw hole mismatch may prevent proper assembly during surgery.

    Product
    Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0615-2018·2018-04-04

    Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date

    Apollo Care is recalling 96 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1209-2018·2018-04-04

    Johnson & Johnson Recalls ACUVUE OASYS Contact Lenses Due to Foreign Matter

    Johnson & Johnson Vision Care is recalling specific lots of ACUVUE OASYS contact lenses because foreign matter was found between the blister package and foil.

    Product
    ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1211-2018·2018-04-04

    Johnson & Johnson Recalls 1-DAY ACUVUE Moist for Astigmatism Contact Lenses

    Johnson & Johnson Vision Care is recalling 1-DAY ACUVUE Moist for Astigmatism contact lenses due to reports of foreign matter found between the blister package and foil.

    Product
    1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1271-2018·2018-04-04

    MedComp Recalls CT Port Kits Packaged with Incorrect Unmarked Guidewire

    Medical Components, Inc. is recalling 8F Plastic Dignity Low Profile CT Port kits because they were packaged with unmarked guidewires instead of the marked ones indicated on the label.

    Product
    8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0611-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Gluconate Oral Rinse Unit Dose Cups

    Akorn, Inc. is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups due to product crystallization and low assay results.

    Product
    Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1241-2018·2018-04-04

    Encore Medical Recalls AltiVate Reverse Humeral Socket Shell Trials

    Encore Medical is recalling AltiVate Reverse Humeral Socket Shell Trials due to broken or missing screws and retaining clips.

    Product
    AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1172-2018·2018-04-04

    Getinge Hemashield Cardiovascular Fabric Recalled for Packaging Mislabeling

    Getinge US Sales LLC is recalling Hemashield Knitted Double Velour Cardiovascular Fabric because the packaging label lists a different product size than the actual item inside.

    Product
    HEMASHIELD Knitted Double Velour Cardiovascular Fabric
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1261-2018·2018-04-04

    Siemens Syngo.via software recall due to data archiving configuration error

    Siemens is recalling 165 units of Syngo.via software because a software upgrade disabled a data cleanup function, causing incorrect archiving flags and reduced disk capacity.

    Product
    Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
    Category
    Medical Device
    Distribution
    0 states

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