The Recall Desk

Archive

April 2017 recalls

850 recalls were announced in April 2017.

What the numbers show

Critical
98
Severe
177
High
432
Moderate
121
Low
22

Of the 850 recalls this month scored against our rubric, 12% are Critical, 21% are Severe.

801–850 of 850

  • HighFDA (Devices)·Z-1614-2017·2017-04-05

    Recall of Regard Sterile Total Knee Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 70 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1589-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 344 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1789-2017·2017-04-05

    Kusher LLC Recalls Shishka Cookies Due to Allergen Labeling Error

    Kusher LLC is recalling Shishka Cookies because the packaging failed to list egg and milk in the 'Contains' statement, despite listing them in the ingredients.

    Product
    COOKIES SHISHKA, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ), UPC: 8 51929 00362 3. The label is read in parts: "***COOKIES "SHISHKA" *** INGREDIENTS: WHEAT FLOUR (FLOUR, NIACIN, IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID) ASCORBIC…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1655-2017·2017-04-05

    FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 288 robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1627-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 165 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1602-2017·2017-04-05

    Recall of Regard Sterile Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 40 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1671-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 454 Regard custom procedure trays because the included light gloves can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1647-2017·2017-04-05

    Recall of Regard Sterile Open Heart Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 228 sterile open heart procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1555-2017·2017-04-05

    Recall of Regard Sterile Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 88 kits of Regard sterile procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of Angels
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1598-2017·2017-04-05

    Recall of Regard Sterile Lap Chole Kits Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 834 sterile lap chole kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1605-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 276 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1558-2017·2017-04-05

    Recall of Regard Sterile Breast PK Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation Llc is recalling 14 kits of Regard sterile breast PK procedure trays because a light glove component can split during use, breaking the sterile field.

    Product
    Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1612-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 158 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1643-2017·2017-04-05

    Resource Optimization Recalls Sterile C-Section Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 430 sterile C-section kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1620-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 120 sterile custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1770-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman Cheese Due to E. coli

    Cumberland Valley Creamery is recalling Luqman Cheese, Yellow Colby Buffalo, because laboratory analysis found levels of E. coli exceeding allowed limits.

    Product
    Luqman Cheese, Yellow Colby Buffalo, Net Weight 8 oz., Dist by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1649-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Compromise

    Resource Optimization & Innovation Llc is recalling 436 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800411003, Sterile, NU0480C- Neuro PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1662-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 350 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0619-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 189 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1569-2017·2017-04-05

    Resource Optimization Recalls 18 Sterile Total Hip Procedure Trays

    Resource Optimization & Innovation LLC is recalling 18 sterile total hip procedure trays because a light glove component can split and break the sterile field.

    Product
    Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1559-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 156 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0620-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 40 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2017·2017-04-05

    Recall of Sterile Robotic Laparoscopic Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 92 sterile robotic laparoscopic procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1648-2017·2017-04-05

    Recall of Regard Sterile Neuro PK Spohn Procedure Trays

    Resource Optimization & Innovation Llc is recalling 1,056 sterile procedure trays because a light glove component can split and break the sterile field.

    Product
    Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1567-2017·2017-04-05

    Recall of Pacemaker Procedure Kits Due to Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 28 sterile pacemaker procedure kits because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1703-2017·2017-04-05

    Siemens Dimension Vista Lab Systems Recalled for Potential ECREA Test Inaccuracy

    Siemens is recalling Dimension Vista 500 and 1500 lab systems because ECREA test results may be falsely elevated in isolated cases.

    Product
    Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1736-2017·2017-04-05

    Give and Go Recalls Two-Bite Turtle Brownie Platters Due to Weevil Larvae

    Give and Go Prepared Foods is recalling Two-Bite Turtle Brownie Party Platters because dried weevil larvae may be present in the product.

    Product
    Two-Bite Turtle Brownie Party Platter 16 x 12.2 oz (346g) item number 09904
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1690-2017·2017-04-05

    Nonin 8500M Handheld Pulse Oximeters Recalled for Incorrect Memory Board

    Nonin Medical is recalling 15 units of the 8500M Handheld Pulse Oximeter because some devices may contain an incorrect pulse oximetry board lacking the integrated memory feature.

    Product
    8500M Handheld Pulse Oximeter
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0617-2017·2017-04-05

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications and long-term stability testing.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2017·2017-04-05

    Siemens Syngo.x PACS Software Recalled for Addressing Multiple Issues

    Siemens Medical Solutions is recalling 104 Syngo.x PACS systems to install software updates that address several unspecified issues.

    Product
    Syngo.x, Picture archiving and communication system Syngo via is a software solution 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1694-2017·2017-04-05

    Medtronic Recalls Single SynchroMed II Implantable Drug Infusion Pump

    Medtronic is recalling one SynchroMed II implantable drug infusion pump in Illinois due to a programmer error code that prevented updates.

    Product
    SynchroMed II implantable drug infusion pump, Model 8637-40,
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1689-2017·2017-04-05

    Siemens Syngo.via Software Recall for Medical Image System Issues

    Siemens Medical Solutions is recalling 104 units of Syngo.via picture archiving software to address several identified issues.

    Product
    Syngo.via, Picture archiving and communication system Syngo via is a software solution 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2017·2017-04-05

    Baxter SIGMA Spectrum Infusion Pump Software Anomaly Recall

    Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library due to a software anomaly that may cause a Sharp Watchdog Timeout error.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1701-2017·2017-04-05

    Biomet 3i Recalls Dental Implants Due to Potential Label Mismatch

    Biomet 3i is recalling five units of LTX dental implants because a single part in the lot may not match the label due to a supplier error.

    Product
    BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0624-2017·2017-04-05

    Sensodyne Toothpaste Recalled for Foreign Substance and Off-Flavor Complaints

    GSK Consumer Healthcare is recalling Sensodyne Repair & Protect Whitening toothpaste due to the presence of a foreign substance and low concentration of patchouli oil, causing off-flavor and scent complaints.

    Product
    SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1737-2017·2017-04-05

    Give and Go Recalls Pecan Tarts Due to Weevil Larvae

    Give and Go Prepared Foods is recalling Two-Bite Pecan Tarts because dried weevil larvae may be present in the product.

    Product
    Two-Bite Pecan Tarts Party Platter 16 x 16.2 (460g) item number 09877
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2017·2017-04-05

    Merge Eye Care Systems Software Recall Due to Image Acquisition Failure

    Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.

    Product
    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2017·2017-04-05

    Focus Diagnostics Legionella IFA Substrate Slide Recalled for Regulatory Status

    Focus Diagnostics is recalling Legionella IFA Substrate Slides because the device was found not to be 510(k) exempt.

    Product
    Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1685-2017·2017-04-05

    Focus Diagnostics Legionella IFA Recalled for Regulatory Status Error

    Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.

    Product
    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1698-2017·2017-04-05

    AGFA DX-D100 X-Ray System Recalled for Missing Allen Wrench Storage Instructions

    AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.

    Product
    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
    Category
    Medical Device
    Distribution
    35 states
  • LowFDA (Drugs)·D-0623-2017·2017-04-05

    Hetero USA Recalls Montelukast Sodium Tablets Due to Discoloration

    Hetero USA Inc. is recalling 65,664 bottles of Montelukast sodium tablets due to a complaint of blue spots and powder inside a sealed bottle.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1738-2017·2017-04-05

    Give and Go Mini Pecan Tarts Recalled for Dried Weevil Larvae

    Give and Go Prepared Foods is recalling Mini Pecan Tarts because dried weevil larvae may be present in the product.

    Product
    The Bakery Mini Pecan Tarts Part Platter NET WT 16x 16.2 OZ (460g) item number 08535
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1735-2017·2017-04-05

    Give and Go Recalls Pecan Tarts Due to Potential Weevil Larvae

    Give and Go Prepared Foods is recalling specific pecan tart products because dried weevil larvae may be present.

    Product
    Two-Bite Pecan Tart 9.2 oz (261g) item number 02023; NL Two-Bite Pecan Tarts 24 x 9.2 oz (261g) item number 02046; Sweet P's Bake Shop Pecan Tarts NET WT 9.2 oz (261g) item number 13076
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V228000·2017-04-04

    McNeilus Refuse Trucks and Mixers Recalled for CNG Fitting Defect

    McNeilus is recalling 2014-2016 refuse trucks and mixers with Cummins CNG engines due to an incorrect fitting that may cause a gas leak, fire, or engine stall.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER V MIXER, STANDARD MIXER, REFUSE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V230000·2017-04-04

    Gulf Stream Amerilite Trailers Recalled for Incorrect Weight Placards

    Gulf Stream is recalling 2011-2017 Amerilite trailers because incorrect weight information on the Federal Placard may lead to overloading and increased crash risk.

    Product
    GULF STREAM — GULF STREAM AMERILITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17125·2017-04-04

    Fred Meyer Recalls Children's Hooded Sweatshirts and Bomber Jackets

    Fred Meyer is recalling approximately 48,000 children's hooded sweatshirts and girls bomber jackets because the zipper pull can detach, posing choking and laceration hazards.

    Product
    Children's zipper hooded sweatshirts and girls bomber jackets
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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