The Recall Desk

Archive

June 2017 recalls

758 recalls were announced in June 2017.

What the numbers show

Critical
27
Severe
157
High
246
Moderate
293
Low
35

Of the 758 recalls this month scored against our rubric, 4% are Critical, 21% are Severe.

Which agencies issued them

101–200 of 758

  • HighFDA (Devices)·Z-2193-2017·2017-06-21

    GE Healthcare Discovery ML X-ray System Recalled for Scan Timing Defect

    GE Healthcare is recalling 10,884 Discovery ML X-ray systems because a defect may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Discovery Ml X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2017·2017-06-21

    Pentax Video Nasopharyngolaryngoscopes Recalled for Loose Suction Arms

    Pentax of America Inc is recalling 1,701 Video Nasopharyngolaryngoscopes due to loose suction arms. The action documents corrective measures taken in 2010-2011.

    Product
    Video Naso pharyngo Laryngoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2548-2017·2017-06-21

    Medtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect

    Medtronic is recalling 478,465 units of the Pacemaker Angio X3 because an incomplete seal on the inner package may cause the suture material to degrade prematurely.

    Product
    SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2527-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance

    Creganna Medical Devices is recalling 100 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2409-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N236), REF 413171, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2183-2017·2017-06-21

    GE Healthcare LightSpeed VCT X-ray System Recalled for Scan Timing Defect

    GE Healthcare is recalling 10,884 LightSpeed VCT X-ray systems because a defect may cause scans to start before the prescribed delay completes.

    Product
    GE Healthcare LightSpeed VCT X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2017·2017-06-21

    GE Healthcare Discovery NM/CT 670 CZT X-ray System Recall

    GE Healthcare is recalling Discovery NM/CT 670 CZT X-ray systems because a defect may cause scans to start before the prescribed delay completes.

    Product
    GE Healthcare Discovery NM/CT 670 CZT X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2360-2017·2017-06-21

    Bright Farms Arugula Recalled Due to Metal Contamination

    Bright Farms is recalling specific lots of arugula because metal was detected in the product. The firm believes this presents a health hazard.

    Product
    Bright Farms Arugula (4 oz. and 8 oz. package) (4 oz. and 8 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2370-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N328), IVD, REF 418630, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2364-2017·2017-06-21

    Bright Farms Mixed Greens Recalled Due to Metal Contamination

    Bright Farms is recalling Mixed Greens 4oz packages because metal was detected in the product. The firm believes there is a risk of a health hazard.

    Product
    Bright Farms Mixed Greens 4oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2533-2017·2017-06-21

    Applied Medical Recalls Kii Trocars Due to Sterilization Concerns

    Applied Medical Resources Corp is recalling specific Kii trocars due to the possibility of insufficient sterilization. The recall affects 7,939 units distributed in the US and worldwide.

    Product
    Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2543-2017·2017-06-21

    Medtronic Recalls Endo Stitch Polysorb Sutures Due to Seal Defect

    Medtronic is recalling specific Endo Stitch Polysorb sutures because an incomplete inner package seal may cause the material to degrade prematurely.

    Product
    Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2362-2017·2017-06-21

    Bright Farms Thai Basil Recalled Due to Metal Contamination

    Bright Farms is recalling Thai Basil packages due to detected metal contamination. The firm identified the issue through internal verification.

    Product
    Bright Farms Thai Basil 0.75oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2591-2017·2017-06-21

    Merge Healthcare Recalls Merge PACS Software Due to Image Display Defect

    Merge Healthcare is recalling specific versions of Merge PACS software because a display defect may cause image lines to shift, potentially leading to physician misdiagnosis.

    Product
    Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram-Negative Identification Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram-Negative identification cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2017·2017-06-21

    Biomerieux VITEK 2 Gram Negative Susceptibility Card Container Integrity Recall

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N270), REF 414162, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2359-2017·2017-06-21

    Bright Farms Spring Mix Recalled Due to Metal Contamination

    Bright Farms is recalling Spring Mix salad products in 4 oz. and 8 oz. packages because metal was detected in the product.

    Product
    Bright Farms Spring Mix (4 oz. and 8 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2337-2017·2017-06-21

    Arrow International Recalls ARROWg+ard Blue CVC Kits for Central Venous Access

    Arrow International Inc is recalling ARROWg+ard Blue CVC Kits used for short-term central venous access. The recall affects 27,485 units distributed in the U.S. and 4,371 units internationally.

    Product
    ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N327), IVD, REF 418515, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2017·2017-06-21

    Monica Novii Wireless Patch System Recalled for Battery Damage and Heat

    Monica Healthcare Ltd is recalling the Monica Novii Wireless Patch System due to potential battery damage and excess heat from prolonged charging.

    Product
    Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2501-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N348), IVD, REF 420856, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2369-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P612), REF 22359, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2017·2017-06-21

    Arrow Recalls Single-Lumen Central Venous Catheter Kits Due to Packaging Seal Issues

    Arrow International is recalling single-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2369-2017·2017-06-21

    General Mills Recalls Chocolate Chip Cookie Dough Larabars Due to Packaging Error

    General Mills is recalling chocolate chip cookie dough Larabars that were incorrectly packaged in peanut butter cookie boxes. The product contains cashews, which are not listed on the peanut butter box label.

    Product
    Chocolate chip cookie dough larabars, 10 count , UPC 100-21908-49031 incorrectly packaged in peanut butter cookie larabars boxes, 10 count, UPC000-21908-49154.
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-2322-2017·2017-06-21

    Philips DuraDiagnost X-ray systems recalled for cracked welding joints

    Philips is recalling 98 DuraDiagnost X-ray systems because the tube arm assembly could fall due to cracked welding joints.

    Product
    Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2393-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N212), REF 413061, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance

    Creganna Medical Devices is recalling 150 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance. The devices were distributed in Massachusetts.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2336-2017·2017-06-21

    Arrow Multi-Lumen CVC Kit Recalled by FDA for Medical Device Safety

    Arrow International Inc is recalling Arrow Multi-Lumen CVC Kits under FDA Class II recall Z-2336-2017. The devices are used for short-term central venous access.

    Product
    Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2370-2017·2017-06-21

    Woodland Foods Recalls Birdseye Chiles Due to Undeclared Peanut

    Woodland Foods is recalling D'Allesandro De-stemmed Birdseye Chiles because trace amounts of undeclared peanut were found in the product.

    Product
    D'Allesandro Woodland Foods De-stemmed Birdseye Chiles 1, 5, and 35 lbs., food service, bag in box container, singe unit per case.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2371-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P613), REF 410027, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N202), REF 412863, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2365-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2017·2017-06-21

    Medtronic Recalls BIOSYN Sutures Due to Potential Incomplete Seal

    Medtronic is recalling BIOSYN sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2186-2017·2017-06-21

    GE Healthcare Optima CT540 X-ray System Recalled for Scan Timing Issue

    GE Healthcare is recalling 10,884 Optima CT540 X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Optima CT540 X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2410-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N237), REF 413172, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2017·2017-06-21

    Medtronic Recalls Best Practice Kits Due to Potential Seal Defects

    Medtronic is recalling Best Practice Kits because an incomplete seal may cause the suture material to degrade prematurely.

    Product
    Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2017·2017-06-21

    GE Healthcare Discovery ML DR X-ray System Recalled for Scan Timing Issue

    GE Healthcare is recalling Discovery ML DR X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Discovery Ml DR X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2413-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N243), REF 413392, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2499-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may allow moisture exposure, leading to antibiotic degradation and loss of potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N335), IVD, REF 418985, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2017·2017-06-21

    Merge PACS Software Recalled for Potential Image Display Defect

    Merge Healthcare is recalling specific versions of Merge PACS software because unviewed images may not display correctly, posing a risk of physician misdiagnosis.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2357-2017·2017-06-21

    Bright Farms Baby Spinach Recalled Due to Metal Contamination

    Bright Farms is recalling 4 oz. packages of Baby Spinach because metal was detected in the product. The recall covers specific best-by dates and distribution locations.

    Product
    Bright Farms Baby Spinach (4 oz. package) The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2334-2017·2017-06-21

    Arrow International Recalls Hemodialysis Catheter Kits Due to Packaging Seal Issues

    Arrow International is recalling specific hemodialysis catheterization kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2017·2017-06-21

    Arrow Recalls PICC Kits Due to Potential Packaging Seal Defects

    Arrow International is recalling Pressure Injectable PICC Kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N209), REF 412938, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2017·2017-06-21

    Medtronic Recalls MAXON Sutures Due to Potential Incomplete Seal

    Medtronic is recalling specific MAXON sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2187-2017·2017-06-21

    GE Healthcare Recalls Innova IGS 540 ACT X-ray Systems

    GE Healthcare is recalling 10,884 Innova IGS 540 ACT X-ray systems because a software issue may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare lnnova IGS 540 ACT X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2017·2017-06-21

    GE Healthcare PET/CT X-ray Systems Recalled for Scan Timing Defect

    GE Healthcare is recalling PET/CT X-ray systems because a defect may cause scans to start before a prescribed delay completes.

    Product
    GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2017·2017-06-21

    Philips M3150 Information Center Software Recalled for Component Failure

    Philips is recalling 607 M3150 Information Center units worldwide due to a potential for early component failure. The software is used to display physiologic data and alarms.

    Product
    M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2017·2017-06-21

    Arrow Pressure Injectable PICC Kit Recalled for Quality Concerns

    Arrow International Inc. is recalling Arrow Pressure Injectable PICC Kits due to a Class II recall classification. The devices are used for intravenous therapy and blood sampling.

    Product
    Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2363-2017·2017-06-21

    Bright Farms Lemon Basil Recalled Due to Metal Contamination

    Bright Farms is recalling 0.75oz packages of Lemon Basil because metal was detected in the product. The firm identified the issue through internal verification.

    Product
    Bright Farms LEMON BASIL 0.75oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2386-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N195), REF412609, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2017·2017-06-21

    Arrow Arterial Catheterization Kit Recalled for Potential Sterility Compromise

    Arrow International is recalling Arterial Catheterization Kits because packaging defects may compromise sterility.

    Product
    Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2438-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N263), REF 413755, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2481-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N320), IVD, REF 418204, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2184-2017·2017-06-21

    GE Healthcare CT X-ray Systems Recalled for Scan Timing Defect

    GE Healthcare is recalling Optima CT580 and Discovery RT CT590 RT X-ray systems because scans may start before the prescribed delay completes.

    Product
    GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2017·2017-06-21

    Medtronic Recalls USPACK Suture Kits Due to Potential Seal Defects

    Medtronic is recalling USPACK-SUTURE KITs (Item US1672) because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    USPACK-SUTURE KIT; Item Number: US1672
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2358-2017·2017-06-21

    Bright Farms Spinach Blend Recalled Due to Metal Contamination

    Bright Farms is recalling Spinach Blend (4 oz. packages) because metal was detected in the product. The firm identified the issue through internal verification techniques.

    Product
    Bright Farms Spinach Blend (4 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2382-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N190), REF 412548, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N227), REF 413144, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2578-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Porous Femoral Stems Due to Packaging Failures

    Zimmer Biomet is recalling 9,867 sterile porous femoral stems because packaging design verification tests failed. The recall covers units distributed worldwide.

    Product
    Por fullct fem st 16x200mm, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2595-2017·2017-06-21

    Zimmer Biomet Recalls R-F IM Nails Due to Packaging Design Failures

    Zimmer Biomet is recalling 3,856 sterile-packaged R-F IM Nails because packaging design verification tests failed. The action covers units distributed domestically and internationally.

    Product
    R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2325-2017·2017-06-21

    Pentax Video Cytoscopes Recalled for Loose Suction Arms

    Pentax of America Inc. is recalling Video Cytoscopes to correct loose suction arms. This action retrospectively documents corrections made in 2010-2011.

    Product
    Video Cytoscopes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0901-2017·2017-06-21

    Safecor Health Recalls Atorvastatin Calcium 40mg Tablets Due to CGMP Deviations

    Safecor Health is voluntarily recalling 119 bottles of Atorvastatin Calcium 40mg tablets in Massachusetts and New York due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2396-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P628), REF 414534, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N264), REF 413864, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2414-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N244), REF 413393, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2377-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P619), REF 411944, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2432-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N249), REF 413572, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2475-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N303), IVD, REF 416590, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0905-2017·2017-06-21

    Safecor Health Recalls Metronidazole Tablets Due to CGMP Deviations

    Safecor Health LLC is voluntarily recalling 1,933 bottles of Metronidazole 500mg tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2424-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN75), REF 413432, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2554-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures

    Zimmer Biomet is recalling sterile femoral intramedullary nails because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.

    Product
    Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN74), REF 413941, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2567-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Knee Implants Due to Packaging Failures

    Zimmer Biomet is recalling 9,867 sterile knee implants due to packaging design verification test failures. The field action affects units distributed worldwide.

    Product
    Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2597-2017·2017-06-21

    Zimmer Biomet Recalls Tibial Intramedullary Nails Due to Packaging Failures

    Zimmer Biomet is recalling sterile tibial intramedullary nails because packaging design verification tests failed. The action affects 1,499 units distributed domestically and internationally.

    Product
    TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM…
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-2496-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N330), IVD, REF 418674, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N246), REF 413395, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2457-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Container Integrity

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN90), REF 414779, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2423-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN84), REF 413410, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2561-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Tibial Intramedullary Nails Due to Packaging Failures

    Zimmer Biomet is recalling sterile tibial intramedullary nails because packaging design verification tests failed. The action affects 9,867 units distributed worldwide.

    Product
    Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2433-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N250), REF 413573, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2403-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N232), REF 413116, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2585-2017·2017-06-21

    Cook Inc. Recalls OptiLite Multi-Use Holmium Laser Fibers Due to Reprocessing Instructions

    Cook Inc. is voluntarily recalling OptiLite Multi-Use Holmium Laser Fibers because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2488-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P641), IVD, REF 418590, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0914-2017·2017-06-21

    Pharmedium Recalls Vancomycin Bags With Incorrect Volume Labeling

    Pharmedium Services is recalling 816 bags of Vancomycin HCl injection because the total volume was incorrectly labeled as 500 mL instead of 300 mL.

    Product
    VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
    Category
    Drug
    Distribution
    Distributed nationwide

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