The Recall Desk

Archive

May 2018 recalls

1,113 recalls were announced in May 2018.

What the numbers show

Critical
47
Severe
240
High
488
Moderate
304
Low
34

Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

101–200 of 1113

  • CriticalFDA (Food)·F-1484-2018·2018-05-23

    True Taste Hot Smoked Rainbow Trout Recalled for Botulism Risk

    True Taste, LLC. is recalling hot smoked rainbow trout in California and Illinois due to potential Clostridium botulinum contamination.

    Product
    True Taste Seafood Hot Smoked Rainbow Trout; Ingredients: rainbow trout, salt, original smoke; To be weighed at point of sale - approximately 3/4 lb.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0926-2018·2018-05-23

    AuroMedics Recalls Piperacillin and Tazobactam Injection Due to Glass Particulates

    AuroMedics Pharma LLC is recalling 77,400 vials of Piperacillin and Tazobactam for Injection due to confirmed visible glass particulate matter.

    Product
    PIPERACILLIN AND TAZOBACTAM — PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1774-2018·2018-05-23

    Abbott HeartMate 3 LVAS Implant Kit Recalled for Graft Occlusion Risk

    Abbott is recalling HeartMate 3 LVAS Implant Kits due to reports of outflow graft twist occlusions that can cause serious adverse events.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
    Category
    Medical Device
    Distribution
    35 states
  • SevereFDA (Devices)·Z-1859-2018·2018-05-23

    Medtronic Endo GIA Stapler Sleeves Recalled for Missing Sled Component

    Medtronic is recalling 169,775 Endo GIA stapler sleeves worldwide due to a missing sled component that may prevent staple formation, risking bleeding or leakage.

    Product
    (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX (4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1866-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1816-2018·2018-05-23

    COVIDIEN Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component

    COVIDIEN MEDTRONIC is recalling 171,271 Endo GIA Universal Articulating Loading Units because a missing sled component may prevent proper staple deployment, risking bleeding or leakage during surgery.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1840-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal and Universal XL staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    (1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0154 BYPASS KH NORDWEST (Item Number: KITDE0154, KITDE0154 BYPASS KH NORDWEST Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, tri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1832-2018·2018-05-23

    COVIDIEN Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled

    COVIDIEN Medtronic is recalling Endo GIA universal stapler kits because a missing sled component may prevent proper staple deployment, risking bleeding or leakage.

    Product
    BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1850-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling 169,775 Endo GIA universal staplers worldwide and in the US because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the sele
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1843-2018·2018-05-23

    Medtronic Recalls Bariatric Surgical Kits Due to Missing Staple Sled Component

    Medtronic is recalling 169,775 bariatric surgical kits worldwide because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Code: SGGLOGX1 ZESTAW DO BARIATRII (4)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Coder:SGGLOGX1 ZESTAW DO BARI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1848-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1826-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Universal and Universal XL staplers worldwide due to a missing sled component that may cause staple line failure, bleeding, or leakage.

    Product
    (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0) (3) BOX BOX1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0 BBR STVEIT GASTRIC B) Product Usage:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1828-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Universal staplers because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-sta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1839-2018·2018-05-23

    Medtronic Recalls Bypass Kits Due to Missing Stapler Component

    Medtronic is recalling 171,271 Endo GIA Bypass Kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1838-2018·2018-05-23

    COVIDIEN Medtronic Recalls VATS Lobectomy Kits Due to Missing Sled Component

    COVIDIEN Medtronic is recalling 171,271 VATS lobectomy kits because the device may be missing a sled component. This defect can cause failure to form a staple line, leading to bleeding or leakage during surgery.

    Product
    (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1842-2018·2018-05-23

    Medtronic Endo GIA Stapler Kits Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA stapler kits worldwide because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1849-2018·2018-05-23

    Medtronic Recalls Bariatric Staplers Due to Missing Sled Component

    Medtronic is recalling specific bariatric stapler kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (3) BOX PST03533 KIT APP STAPLER (Item Number: PST03403) Product Usage: The Endo GIA universal and End
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1817-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1456-2018·2018-05-23

    Bombay Kitchen Bhavnagri Mix Recalled for Undeclared Peanuts

    Ethnic Foods, Inc. is recalling Bombay Kitchen Bhavnagri Mix because the product contains undeclared peanuts.

    Product
    Bombay Kitchen Bhavnagri Mix, packaged in a 19 oz., clear bag, UPC: 808550110206
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1455-2018·2018-05-23

    eBars Recalls Organic Dark Chocolate Berry Bars for Peanut Allergen

    eBars is recalling Woman Organic Dark Chocolate Berry bars because testing found undeclared peanut allergen. Consumers with peanut allergies should not eat the product.

    Product
    WOMAN ORGANIC DARK CHOCOLATE BERRY bar NET WT. 1.8 OZ (51g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00418 9
    Category
    Food
    Distribution
    40 states
  • SevereFDA (Devices)·Z-1825-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1837-2018·2018-05-23

    Medtronic Endo GIA Universal Bypass Kits Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA Universal Bypass Kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the sta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1823-2018·2018-05-23

    Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA vascular reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1821-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Reloads Due to Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA 30mm stapler reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1445-2018·2018-05-23

    eBars Recalls Organic Chocolate Peanut Bars for Undeclared Almonds

    eBars is recalling FOCUS Organic Chocolate Peanut bars because they contain undeclared almonds. The recall affects 33,115 units shipped to multiple states.

    Product
    FOCUS ORGANIC CHOCOLATE PEANUT bar NET WT. 1.6 OZ (45g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00417 2
    Category
    Food
    Distribution
    40 states
  • SevereFDA (Devices)·Z-1863-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX VATS1SCDX DO ZABIEGOW VATS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1815-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1847-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling 169,775 Endo GIA Universal and Universal XL staplers worldwide and in the US because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0840-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling specific lots of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0811-2018·2018-05-23

    Milbar Recalls B Prox 10 Anti-blemish Wash Due to Microbial Contamination

    Milbar Laboratories is recalling 3,477 bottles of B Prox 10 Anti-blemish Wash due to microbial contamination. Consumers should stop using the product and return it to the point of purchase.

    Product
    B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1822-2018·2018-05-23

    Medtronic Endo GIA Stapler Reloads Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA 30mm stapler reloads because a missing sled component may cause staple failure, leading to bleeding or leakage.

    Product
    Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1852-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    BOX PST03533 KIT APP STAPLER Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1824-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA stapler kits worldwide because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1831-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered row
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1814-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1865-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX VMIN ZESTAW DO VATS PODSTAWOWY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1830-2018·2018-05-23

    COVIDIEN Medtronic Recalls Endo GIA Staplers for Missing Sled Component

    COVIDIEN Medtronic is recalling approximately 171,271 Endo GIA universal staplers because a missing sled component may prevent proper staple deployment. This defect can lead to bleeding or leakage of luminal contents during surgery.

    Product
    (1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1820-2018·2018-05-23

    Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1862-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is deter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal and Universal XL staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1475-2018·2018-05-23

    Van's Gluten Free Waffles Recalled for Missing Allergen Labeling

    Van's gluten free Original 6 Waffles are being recalled because the ingredient statement failed to list milk and wheat.

    Product
    Vans gluten free Original 6 WAFFLES NET WT 9 OZ (255g) INGREDIENTS:***VAN'S GLUTEN FREE MIX (BROWN RICE FLOUR, POTATO STARCH, RICE FLOUR, SOY FLOUR),***RICE FLOUR,***SUNFLOWER AND/OR SOY LECITHIN***CONTAINS: SOY DISTRIBUTED BY: VAN'S INTERNATIONAL FOODS SAN DIEGO, CA 92154 UPC 0
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1833-2018·2018-05-23

    Medtronic Endo GIA Universal Stapler Kits Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal stapler kits because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2018·2018-05-23

    Zimmer Biomet Recalls Persona Stemmed Tibial Provisional Instruments

    Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential raw material cracks that could compromise cleanliness.

    Product
    Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1882-2018·2018-05-23

    Visaris Diagnostic X-Ray System Recalled for Tube Arm Suspension Failure

    Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and injury.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this syste
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1892-2018·2018-05-23

    Southmedic Recalls Sterile Scalpels Labeled as Non-Sterile

    Southmedic, Inc. is recalling 3,300 sterile disposable scalpels because the product contains non-sterile items labeled as sterile.

    Product
    Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1868-2018·2018-05-23

    Richard Wolf Tube Set for TEM Recalled for Potential Tube Mixing

    Richard Wolf GmbH is recalling 1,710 units of the Tube Set for TEM (Ref 4170.801) because tube ends may be mixed up.

    Product
    RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1881-2018·2018-05-23

    Visaris Diagnostic X-Ray Systems Recalled for Tube Arm Suspension Failure Risk

    Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and patient injury.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1867-2018·2018-05-23

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Inaccurate Pressure Readings

    Invivo is recalling 4,375 Xper Flex Cardio Physiomonitoring Systems because ventricular end-diastolic pressure readings may be inaccurate. The issue affects specific model numbers used in cardiac catheterization rooms.

    Product
    PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-inv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2018·2018-05-23

    Visaris Diagnostic X-Ray System Recalled for Tube Arm Suspension Failure

    Visaris DOO is recalling specific diagnostic X-ray systems due to a potential failure in the tube arm suspension that could cause the arm to descend uncontrollably.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this syste
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1889-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect

    Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2018·2018-05-23

    Tosoh HbA1c Pretreatment Solution Recalled for Potential Inaccurate Test Results

    Tosoh Bioscience Inc is recalling HbA1c Pretreatment Solution because it may cause erroneously elevated or decreased patient test results.

    Product
    Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2018·2018-05-23

    Ev3 MindFrame Capture Devices Recalled for Potential Wire Separation

    Micro Therapeutics is recalling MindFrame Capture LP Revascularization Devices because they may partially detach from the delivery wire.

    Product
    MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1454-2018·2018-05-23

    eBars Recalls Organic Dark Cocoa Raspberry Bars for Peanut Allergen

    eBars is recalling 26,180 units of TRIM Organic Dark Cocoa Raspberry bars because they tested positive for peanut, an allergen not declared on the label.

    Product
    TRIM ORGANIC DARK COCOA RASPBERRY bar NET WT. 1.8 OZ (51g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00423 1
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-1746-2018·2018-05-23

    Siemens Recalls CT Scanner Software for Radiation Risk

    Siemens Medical Solutions is recalling 134 SOMATOM Definition Edge CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1745-2018·2018-05-23

    Siemens CT Scanners Recalled for Potential Unnecessary Radiation Exposure

    Siemens Medical Solutions is recalling 1,385 SOMATOM Definition AS CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1453-2018·2018-05-23

    eBars Recalls Trim Organic Chocolate Almond Bars for Peanut Allergen

    eBars is recalling Trim Organic Chocolate Almond bars because they tested positive for peanut, an allergen not declared on the label.

    Product
    TRIM ORGANIC CHOCOLATE ALMOND bar NET WT. 1.6 OZ (45g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00423 0
    Category
    Food
    Distribution
    40 states
  • HighFDA (Food)·F-1448-2018·2018-05-23

    eBars Recalls Organic Dark Cocoa Raspberry Bars for Undeclared Peanut

    eBars is recalling 4,284 units of GOLF Organic Dark Cocoa Raspberry bars because they tested positive for peanut, an allergen not listed on the label.

    Product
    GOLF ORGANIC DARK COCOA RASPBERRY bar NET WT. 1.6 OZ (45g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00402 8
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-1810-2018·2018-05-23

    Tosoh HbA1c Calibrator Recalled for Potential Inaccurate Patient Results

    Tosoh Bioscience Inc is recalling HbA1c Calibrators because they may cause erroneous patient test results.

    Product
    Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2018·2018-05-23

    Siemens CT Scanners Recalled for Potential Unnecessary Radiation Exposure

    Siemens is recalling 238 SOMATOM Definition Flash CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1450-2018·2018-05-23

    eBars Recalls Organic Chocolate Almond Bars Due to Peanut Allergen

    eBars is recalling 48,969 units of MAN Organic Chocolate Almond bars because they tested positive for peanut, an undeclared allergen.

    Product
    MAN ORGANIC CHOCOLATE ALMOND bar NET WT. 1.8 OZ (51g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00414 1
    Category
    Food
    Distribution
    40 states
  • HighFDA (Food)·F-1449-2018·2018-05-23

    eBars Recalls Organic Chocolate Peanut Bars for Undeclared Almond Allergen

    eBars is recalling HEAL Organic Chocolate Peanut bars because testing revealed the presence of undeclared almond allergen.

    Product
    HEAL ORGANIC CHOCOLATE PEANUT bar NET WT. 1.6 OZ (45g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00439 4
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-1877-2018·2018-05-23

    Micro-Tech Trident Endoscopic Ultrasonic Biopsy Needle Recall

    Micro-Tech is recalling 40 Trident Endoscopic Ultrasonic Biopsy Needles because they may break in the human body, potentially causing injury.

    Product
    Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1444-2018·2018-05-23

    eBars Recalls Organic Peanut Butter Bars for Undeclared Almonds

    eBars is recalling FIT Organic Peanut Butter Chocolate Raspberry bars because they contain undeclared almonds. The recall was initiated after notification from the State of Tennessee.

    Product
    FIT ORGANIC PEANUT BUTTER CHOCOLATE RASPBERRY bar NET WT 1.8 OZ (51g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00443 1
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-1819-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may cause staple line failure, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1451-2018·2018-05-23

    eBars Recalls Run Organic Chocolate Almond Bars for Peanut Allergen

    eBars is recalling Run Organic Chocolate Almond bars because they tested positive for peanut, an allergen not declared on the label.

    Product
    RUN ORGANIC CHOCOLATE ALMOND bar NET WT. 1.6 OZ (45g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00404 2
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-1803-2018·2018-05-23

    Bard Peripheral Vascular Seeker Crossing Support Catheter Recalled for Endotoxin Risk

    Bard Peripheral Vascular Inc is recalling 130 units of Seeker Crossing Support Catheters due to potential bacterial endotoxin on packaging hoops, posing a cross-contamination risk.

    Product
    BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V337000·2018-05-23

    Land Rover Recalls 2017 Models for Fuel Gauge Software Error

    Jaguar Land Rover is recalling 2017 Range Rover, Range Rover Sport, and Discovery vehicles because a software error may cause the engine to shut off unexpectedly.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, DISCOVERY, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2018·2018-05-23

    Kelyniam Custom Skull Implant Recall for Unvalidated Design Changes

    Kelyniam Global is recalling 23 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1441-2018·2018-05-23

    Market District Roasted Salted Cashews Recalled for Undeclared Allergens

    Kanan Enterprises is recalling Market District Roasted Salted Cashews because the product contains almonds and pecans that are not listed on the label.

    Product
    Market District Roasted Salted Cashews Whole Fancy Net WT 26 oz (1LB 10 OZ) 737g. Ingredients: Cashews, Canola and/or Peanut Oil, Salt. Distributed by Giant Eagle, Inc. Pittsburgh, PA 15238-2809 UPC 0 30034 10382 8
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1811-2018·2018-05-23

    Tosoh Bioscience Recalls HbA1c Control Due to Erroneous Results

    Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c Control because the product may generate erroneously elevated or decreased HbA1c patient results.

    Product
    Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2018·2018-05-23

    Zimmer Biomet Recalls Persona Stemmed Tibial Provisional Instruments

    Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential cracks in the raw material that could compromise cleanliness.

    Product
    Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2018·2018-05-23

    Medtronic Endo GIA Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1447-2018·2018-05-23

    eBars Recalls Organic Chocolate Almond Bars Due to Peanut Allergen

    eBars is recalling GOLF Organic Chocolate Almonds bars because they tested positive for peanut, an undeclared allergen. The recall covers 5,391 bags distributed across 37 states.

    Product
    GOLF ORGANIC CHOCOLATE ALMONDS bar NET WT. 1.6 OZ (45g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00400 4
    Category
    Food
    Distribution
    40 states
  • HighFDA (Devices)·Z-1809-2018·2018-05-23

    Tosoh Bioscience Recalls HbA1c Reagent Due to Potential Test Errors

    Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c reagents because the assay may produce erroneously high or low Hemoglobin A1c results.

    Product
    Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling two Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1452-2018·2018-05-23

    eBars Recalls Organic Dark Cocoa Raspberry Bars for Undeclared Peanut Allergen

    eBars is recalling 2,903 units of RUN Organic Dark Cocoa Raspberry bars because testing revealed the presence of peanut, an allergen not declared on the product label.

    Product
    RUN ORGANIC DARK COCOA RASPBERRY bar NET WT. 1.6 OZ (45g) Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00412 7
    Category
    Food
    Distribution
    40 states
  • HighNHTSA·18V333000·2018-05-23

    Forest River Recalls Vengeance Trailers for Missing Side Marker Lights

    Forest River is recalling 2017-2019 Vengeance Rouge recreational trailers because they may be missing side marker lights, reducing visibility to other drivers.

    Product
    FOREST RIVER — FOREST RIVER VENGEANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2018·2018-05-23

    Medtronic Endo GIA Universal Stapler Sleeves Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal stapler sleeves and bypass units because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    (1)BOX PST04089 SLEEVE AIWA CLINIC Item Number:PST04089 SLEEVE AIWA CLINIC (2)BOX PST04090 BYPASS AIWA CLINIC Item Number: PST04090 BYPASS AIWA CLINIC Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling 16 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2018·2018-05-23

    Draeger Infinity Acute Care System Recalled for Software Anomaly

    Draeger Medical Systems is recalling the Infinity Acute Care System due to a software anomaly that can cause loss of patient settings and stored data.

    Product
    Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1876-2018·2018-05-23

    Nipro Blood Tubing Set Recalled Due to Potential Heparin Line Occlusion

    Nipro Medical Corporation is recalling specific blood tubing sets used in hemodialysis because the heparin line may be occluded.

    Product
    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1442-2018·2018-05-23

    Zoi Mixed Berry Greek Yogurt Parfait Recalled for Coconut Labeling Error

    A G Specialty Foods is recalling Zoi Mixed Berry Greek Yogurt Parfaits because coconut is listed in ingredients but missing from the 'Contains' statement.

    Product
    Zoi Mixed Berry Greek Yogurt Parfait, 9 oz. clear plastic cup, covered with a clear plastic snap-on lid. UPC 8 17203 02172 1. The label is read in parts: "***Honey Greek Yogurt Willamette Valley Mixed Berries Honey Almond Granola Parfait***KEEP REFRIGERATED***INGREDIENTS: HONE
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1473-2018·2018-05-23

    Great Value Organic Ground Flax Seed Recalled for Metal Fragments

    Healthy Food Ingredients is recalling Great Value Organic Ground Flax Seed due to the potential presence of metal fragments.

    Product
    Great Value Organic Ground Flax Seed, Net Wt. 16 oz. (1 LB) 454g. UPC 78742-14161, and Net Wt. 32 oz. (2 LB) 907g, UPC 78742-14165 Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1748-2018·2018-05-23

    Siemens SOMATOM Force CT scanners recalled for radiation exposure risk

    Siemens is recalling 91 SOMATOM Force CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1829-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180APPE1 APPENDIX KIT ZAMS) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1808-2018·2018-05-23

    Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks

    Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units because potential cracks in the raw material could compromise the cleanliness of the instruments.

    Product
    Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2018·2018-05-23

    Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks

    Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units due to potential cracks in the raw material that could compromise product cleanliness.

    Product
    Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2018·2018-05-23

    Medtronic Endo GIA Stapler Recall Due to Missing Sled Component

    Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is deter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling 54 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0805-2018·2018-05-23

    Prescript Pharmaceuticals Recalls Clindamycin Capsules Due to Labeling Error

    Prescript Pharmaceuticals is recalling 50 containers of Clindamycin 150 mg capsules in California due to a storage temperature labeling discrepancy.

    Product
    Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1869-2018·2018-05-23

    Rockwell Medical Recalls DriSate Hemodialysis Acid Concentrate Due to Contamination

    Rockwell Medical is recalling DriSate hemodialysis acid concentrate because a subassembly component contained small amounts of sodium bicarbonate from a prior batch.

    Product
    DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0819-2018·2018-05-23

    Mylan Recalls Amlodipine and Benazapril Capsules Due to Cleaning Deviations

    Mylan Pharmaceuticals is recalling specific lots of Amlodipine and Benazapril HCL Capsules because the cleaning process for manufacturing equipment was not followed according to procedure.

    Product
    Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
    Category
    Drug
    Distribution
    0 states

Looking for a different month? Back to 2018.