The Recall Desk

Archive

May 2019 recalls

587 recalls were announced in May 2019.

What the numbers show

Critical
22
Severe
152
High
209
Moderate
184
Low
20

Of the 587 recalls this month scored against our rubric, 4% are Critical, 26% are Severe.

101–200 of 587

  • HighFDA (Devices)·Z-1371-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips Due to Fit Issues

    Polymer Technology Systems is recalling Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect results.

    Product
    Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1434-2019·2019-05-29

    Zimmer GmbH Recalls Stryker 3.5mm Screw Drills Due to Material Concerns

    Zimmer GmbH is recalling Stryker 3.5mm screw drills because they may have been manufactured from a different material than specified.

    Product
    Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1448-2019·2019-05-29

    Zimmer GmbH Recalls V-TEK IVP Step Drills Due to Material Concerns

    Zimmer GmbH is recalling V-TEK IVP step drills because an investigation found they may be made from a different material than specified.

    Product
    V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
    Category
    Medical Device
    Distribution
    42 states
  • HighNHTSA·19V399000·2019-05-29

    HINO 268 and 338 Vehicles Recalled for Backup Camera Display Defect

    ITI is recalling 2018-2019 HINO 268 and 338 vehicles because backup camera displays may revert to factory settings, causing reversed images and increasing crash risk.

    Product
    HINO — HINO 268, 338
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2019·2019-05-29

    Dornier Diode Laser Fibers Recalled for Sterility Compromise

    Dornier Medtech America is recalling 400 units of Dornier Diode Laser Fibers due to pin hole package failures that compromise product sterility.

    Product
    Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use fiber K2011826 600 micron 5X reusable fiber K1008084 600 micron single use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1307-2019·2019-05-29

    Septodont Recalls Articadent Dental Cartridges Due to Carton Mislabeling

    Septodont Inc. is recalling 240 cartons of Articadent dental cartridges because the printed cartons contained text for both Articadent and Xylocaine, though the cartridges themselves are correctly labeled.

    Product
    ARTICADENT — ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1294-2019·2019-05-29

    Mallinckrodt Recalls Amitiza Capsules Due to Labeling Mix-Up

    Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules because 8 mcg and 24 mcg bottles were found with incorrect contents.

    Product
    AMITIZA — AMITIZA (LUBIPROSTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1401-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recall for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because products may fail performance testing after 106 days from manufacturing.

    Product
    Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1436-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the applicable specifications.

    Product
    Drill, cannulated, 4x150mm, AO, Item Number 502015403
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1422-2019·2019-05-29

    Zimmer GmbH Recalls 2.5x87mm AO Drills Due to Material Concerns

    Zimmer GmbH is recalling specific AO drills because they may be made from the wrong material. The products were distributed to 38 US states.

    Product
    Drill, 2.5x87mm, AO, Item Number 502015137
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1403-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.

    Product
    Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1483-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills that may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 3.5x90mm, round shaft, Item Number ST502015635
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1372-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips for Fit Issues

    Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.

    Product
    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2019·2019-05-29

    KaVo Recalls DEXIS Titanium Intraoral Sensors Due to Calibration Error

    KaVo Dental Technologies is recalling 211 DEXIS Titanium Intraoral Sensors because incorrectly programmed calibration files may reduce image quality.

    Product
    DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1404-2019·2019-05-29

    Remel Thio Med Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is being shortened to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1406-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

    Remel Inc is recalling 1,069 units of Thio Med w/Dex, Hem, Vit K media due to potential performance failures after 106 days.

    Product
    Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1281-2019·2019-05-29

    NeuViz 16 Essence CT Scanner Recalled for Software Defect

    Neusoft Medical Systems is recalling two NeuViz 16 Essence CT scanners due to a software defect that may cause image loss during specific scans.

    Product
    NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1467-2019·2019-05-29

    Zimmer GmbH Recalls V-TEK Micro-countersink Due to Material Concerns

    Zimmer GmbH is recalling V-TEK Micro-countersink items because they may be made from the wrong material. The products were distributed to 39 US states.

    Product
    V-TEK", Micro-countersink, AO , Item Number ST28.66.113
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1390-2019·2019-05-29

    Thommen Medical Recalls Dental Adapters for Handpiece Due to Deformation Risk

    Thommen Medical AG is recalling 15 units of dental adapters for handpieces because the coupling may deform, making removal difficult.

    Product
    Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and scre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1379-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.

    Product
    Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1426-2019·2019-05-29

    Stryker 2.7mm Screw Drill Recalled for Material Specification Deviation

    Zimmer GmbH is recalling Stryker 2.7mm screw drills because they may be made from a different material than specified.

    Product
    Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1408-2019·2019-05-29

    Remel Thio Med Culture Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med culture media due to potential performance failures after 106 days. The expiration date is shortened to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2019·2019-05-29

    Neusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect

    Neusoft Medical Systems is recalling 37 NeuViz 64 CT scanners due to a software defect that can cause image loss during specific scans.

    Product
    NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by comp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1441-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because an investigation found they may have been manufactured from a different material than specified.

    Product
    Drill, cannulated, 2.8x120mm, AO, Item Number 502015628
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1407-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recall for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 106 days. The expiration date is being shortened to 105 days.

    Product
    Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1438-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1429-2019·2019-05-29

    Stryker 2.7mm Screw Drill Recalled for Material Specification Deviation

    Zimmer GmbH is recalling Stryker 2.7mm screw drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1414-2019·2019-05-29

    Zimmer GmbH Recalls Drill Sys2.7 Due to Material Specification Deviation

    Zimmer GmbH is recalling Drill Sys2.7 surgical instruments because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill Sys2.7, 2x103mm, AO, Item Number 502015107
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Food)·F-1397-2019·2019-05-29

    Goji Powder Recalled Due to Fungicide Carbendazim Presence

    Xi'an Yuensun Biological Technology Co., Ltd. is recalling Goji Powder because it contains the fungicide carbendazim. The product was distributed in the U.S. and several foreign countries.

    Product
    Goji Powder (aka Wolfberry Powder)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1442-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 2.8x150mm, AO, Item Number 502015629
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1443-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications. The products were distributed to 41 US states.

    Product
    Drill, cannulated, 3x90mm, round shaft, Item Number 502015630
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1378-2019·2019-05-29

    Remel Inc Recalls Thio Med w/Dex, Hemin, Vit K Media

    Remel Inc is recalling Thio Med w/Dex, Hemin, Vit K media because the products may fail performance testing after 57 days.

    Product
    Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1460-2019·2019-05-29

    Zimmer GmbH Recalls CBS Micro Countersink Cannulated AO Screws

    Zimmer GmbH is recalling CBS micro, countersink, cannulated, AO screws (Item Number 503004541) because they may have been manufactured from a different material than specified.

    Product
    CBS micro, countersink, cannulated, AO, Item Number 503004541
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1440-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling specific cannulated orthopedic drills because an investigation found they may have been manufactured from a different material than specified.

    Product
    Drill, cannulated, 2x95mm, AO, Item Number 502015623
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1280-2019·2019-05-29

    Neusoft NeuViz 128 CT Scanner Recalled for Software Defect

    Neusoft Medical Systems is recalling six NeuViz 128 CT scanners due to a software defect that may cause image loss during specific scans.

    Product
    NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and detector array. The acquired x-ray transmission data is reconstructed by com
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

    Boston Scientific is recalling six Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause power degradation and stop laser emission.

    Product
    AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perfo
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1445-2019·2019-05-29

    Zimmer V-TEK IVP Step Drill Recalled for Material Specification Deviation

    Zimmer GmbH is recalling V-TEK IVP step drills because they may have been manufactured from a different material than specified.

    Product
    V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1447-2019·2019-05-29

    Zimmer V-TEK IVP Step Drill Recalled for Material Specification Deviation

    Zimmer GmbH is recalling V-TEK IVP step drills because they may have been manufactured from a material different from the applicable specifications.

    Product
    V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1451-2019·2019-05-29

    Zimmer GmbH Recalls AO Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling specific AO orthopedic drills because they may be made from the wrong material. The products were distributed to 39 US states.

    Product
    Drill, 3.2x145mm, AO, Item Number 502015650
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1398-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inci
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1370-2019·2019-05-29

    Cook Stent Sets Recalled for Missing Warning About Stent Knotting

    Cook Inc. is recalling Kwart RetroInject and Salle Intraoperative Pyeloplasty Stent Sets because the instructions for use did not include a warning for stent knotting.

    Product
    Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1367-2019·2019-05-29

    CooperSurgical Recalls ICSI Micropipettes Due to Missing Bend

    CooperSurgical is recalling 480 ICSI Micropipettes because the required thirty-degree bend is absent. The affected units were distributed in Denmark, Italy, and Sweden.

    Product
    ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1475-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill, cannulated, 4x150mm, AO, Item Number ST502015403
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1402-2019·2019-05-29

    Remel Thio Med Culture Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med culture media due to potential failure to meet performance standards after 106 days from manufacturing.

    Product
    Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1421-2019·2019-05-29

    Stryker 2.5x94mm Drill Recalled for Potential Material Deviation

    Zimmer GmbH is recalling Stryker 2.5x94mm Drills because an investigation found they may have been manufactured from a different material than specified.

    Product
    Drill, 2.5x94mm, Stryker, Item Number 502015136
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1461-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Orthopedic Screws Due to Material Concerns

    Zimmer GmbH is recalling specific cannulated orthopedic screws because they may have been manufactured from a material different from the specifications.

    Product
    CBS high, countersink, cannulated, AO, Item Number 503004542
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1391-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser System for Cooling Defect

    Boston Scientific is recalling specific Auriga XL 4007 laser systems due to a mechanical cooling issue that may cause premature power degradation and low power errors.

    Product
    AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1452-2019·2019-05-29

    Zimmer GmbH Recalls Contra-Angle Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling contra-angle drills that may have been manufactured from a different material than specified. The products were distributed to 41 US states.

    Product
    Drill, contra-angle, 1.5x85mm, Item Number 502015706
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1444-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because an investigation found they may have been manufactured from a different material than defined in specifications.

    Product
    Drill, cannulated, 3x90mm, AO, Item Number 502015631
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1380-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit, K Media Recalled for Performance Failure

    Remel Inc is recalling Thio Med w/Dex, Hem, Vit, K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 days.

    Product
    Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1485-2019·2019-05-29

    Zimmer GmbH Recalls 3.2x145mm AO Drills Due to Material Concerns

    Zimmer GmbH is recalling specific AO drills because they may have been manufactured from a different material than specified.

    Product
    Drill, 3.2x145mm, AO, Item Number ST502015650
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1484-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1428-2019·2019-05-29

    Zimmer GmbH Recalls 2.7mm AO Surgical Drills Due to Material Concerns

    Zimmer GmbH is recalling specific 2.7mm AO surgical drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1456-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Orthopedic Screws Due to Material Concerns

    Zimmer GmbH is recalling specific cannulated orthopedic screws because an investigation found they may have been manufactured from a different material than specified.

    Product
    CBS high, countersink, cannulated, round-shaft, Item Number 503004342
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1465-2019·2019-05-29

    Zimmer GmbH Recalls V-TEK Micro-countersink Due to Material Concerns

    Zimmer GmbH is recalling V-TEK Micro-countersink items because they may have been manufactured from a different material than specified.

    Product
    V-TEK", Micro-countersink, AO, Item Number 28.66.113
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1487-2019·2019-05-29

    Zimmer GmbH Recalls CBS Micro Countersink Cannulated AO Screws

    Zimmer GmbH is recalling CBS micro, countersink, cannulated, AO screws (Item Number ST503004541) because they may have been manufactured from a different material than specified.

    Product
    CBS micro, countersink, cannulated, AO, Item Number ST503004541
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1432-2019·2019-05-29

    Zimmer GmbH Recalls 3.5mm Screw Drills Due to Material Concerns

    Zimmer GmbH is recalling specific 3.5mm screw drills because they may be made from a different material than specified.

    Product
    Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1409-2019·2019-05-29

    Remel Thio Med w/o Ind, w/Dex Recalled for Potential Performance Failure

    Remel Inc is recalling 27 units of Thio Med w/o Ind, w/Dex due to potential failure in performance testing after 106 days.

    Product
    Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1437-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 2x95mm, round shaft, Item Number 502015619
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1469-2019·2019-05-29

    Zimmer GmbH Recalls 2.7mm Orthopedic Drills Due to Material Concerns

    Zimmer GmbH is recalling specific 2.7mm orthopedic drills because they may have been manufactured from a material different from the specifications.

    Product
    Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1396-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1399-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling two Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and a low power error.

    Product
    AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1377-2019·2019-05-29

    Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure

    Remel Inc is recalling 8,615 units of Thio Med w/Dex, Hem, Vit K media due to potential performance failures starting 57 days after manufacturing.

    Product
    Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1369-2019·2019-05-29

    Cook Kwart Retro-Inject Ureteral Stent Set Recalled for Missing Warning

    Cook Inc. is recalling Kwart Retro-Inject Ureteral Stent Sets because the instructions for use did not include a warning for stent knotting.

    Product
    Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ¿ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr AQ-003500 G17150; 6.0 Fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1482-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Potential Material Deviation

    Zimmer GmbH is recalling specific cannulated drills that may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 3x90mm, AO, Item Number ST502015631
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1400-2019·2019-05-29

    Remel Thio Med Culture Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med culture media because the product may fail performance testing after 106 days. The expiration date is being shortened from 9 months to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1477-2019·2019-05-29

    Zimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns

    Zimmer GmbH is recalling specific cannulated drills because they may have been manufactured from a material different from the defined specifications.

    Product
    Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-1405-2019·2019-05-29

    Remel Thio Med Media Recalled for Potential Performance Failure

    Remel Inc is recalling Thio Med w/o Ind, w/Dex media because it may fail performance testing after 106 days. The expiration date is shortened from 9 months to 105 days.

    Product
    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1417-2019·2019-05-29

    Stryker 26mm Drill Recalled for Potential Material Specification Deviation

    Zimmer GmbH is recalling Stryker 26mm drills because an investigation found they may have been manufactured from a different material than specified.

    Product
    Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120
    Category
    Medical Device
    Distribution
    42 states
  • LowFDA (Devices)·Z-1389-2019·2019-05-29

    Collagen Matrix Recalls Neomem Membrane Due to Incorrect Packaging

    Collagen Matrix, Inc. is recalling Neomem Resorbable Collagen Membranes because they were packaged in the wrong box, potentially inside a Neomem FLEXPLUS box.

    Product
    Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·060-2019·2019-05-28

    Richwell Group Recalls Frozen Siluriformes Fish Products for Import Violations

    Richwell Group is recalling 160,020 pounds of frozen fish products imported from Vietnam without proper inspection. No illnesses have been reported.

    Product
    Richwell Group, Inc. Recalls Siluriformes Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V391000·2019-05-24

    Blue Bird Recalls School Buses Due to Rear Brake Dragging Risk

    Blue Bird is recalling 2015-2020 Vision and All American school buses because the driver-side rear brakes may drag, posing a fire and injury risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION, ALL AMERICAN SCHOOL BUS, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·059-2019·2019-05-24

    Sikorski Sausage Products Recalled for Missing Import Inspection

    Sikorski Sausages Co., Ltd. is recalling approximately 74 pounds of imported meat and poultry sausages that were not presented for import re-inspection into the United States.

    Product
    Sikorski Sausages Co., Ltd. Recalls Meat and Poultry Sausage Products Produced without Benefit of Import Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V392000·2019-05-24

    Land Rover Recalls Range Rover Models for Door Latch Defect

    Jaguar Land Rover is recalling 2013-2016 Range Rover and 2014-2016 Range Rover Sport vehicles because doors may appear closed but are unlatched, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V395000·2019-05-24

    Starcraft All Star XL Diesel Fuel Heater Fire Risk Recall

    Forest River is recalling 2018-2019 Starcraft All Star XL diesel vehicles because the fuel heater may overheat, melt plastic, and cause a fire or engine stall.

    Product
    STARCRAFT BUS — STARCRAFT BUS ALLSTAR XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V393000·2019-05-24

    Blue Bird Recalls Buses Due to Rear Brake Dragging Risk

    Blue Bird is recalling certain 2015-2020 Vision and All American non-school buses because driver-side rear brakes may drag, posing a fire and injury risk.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E035000·2019-05-23

    Transfer Flow Recalls Rear Brake Lines for Mobility Van Conversions

    Transfer Flow is recalling rear brake lines for mobility van conversions due to incorrect tube nut fittings that may cause a pressure drop in the braking system.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E036000·2019-05-23

    Meritor recalls steer axles due to insufficient lubrication risk

    Meritor is recalling specific steer axles because insufficient lubrication may damage wheel end bearings, potentially causing wheel separation and loss of vehicle control.

    Product
    POWER TRAIN:AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19125·2019-05-23

    Far East Brokers Recalls Fabulous Home Pineapple Corer and Slicers

    Far East Brokers is recalling Fabulous Home Pineapple Corer & Slicers because the metal blade can detach, posing a laceration hazard.

    Product
    Fabulous Home Pineapple Corer & Slicers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V390000·2019-05-23

    Land Rover Recalls 2016 Range Rovers for Door Latch Defect

    Jaguar Land Rover is recalling 28,671 2016 Range Rover and Range Rover Sport vehicles because a stuck spring may leave the left door unlatched, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V387000·2019-05-23

    GM Recalls 2016-2019 Chevrolet Express and GMC Savana for Window Glass Defect

    General Motors is recalling 2016-2019 Chevrolet Express and GMC Savana vehicles because rear-quarter windows may use tempered glass instead of laminated glass, increasing injury risk in crashes.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19127·2019-05-23

    DICK'S Sporting Goods Recalls Ethos Pull-Up Assist Due To Laceration Hazard

    DICK'S Sporting Goods is recalling Ethos Pull-Up Assist equipment because a plastic clip can break, posing a laceration hazard. Seven reports of equipment breaking resulted in six lacerations.

    Product
    Ethos Pull-Up Assist
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V386000·2019-05-23

    BMW Recalls 2019 X7 Vehicles Due to Head Air Bag Alignment Defect

    BMW is recalling 2019 X7 xDrive40i and xDrive50i vehicles because the driver and passenger head air bags may not be properly aligned, potentially impairing deployment and increasing injury risk.

    Product
    BMW — BMW X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·058-2019·2019-05-23

    Blount Fine Foods Recalls Chicken Tortilla Soup Due to Plastic Contamination

    Blount Fine Foods is recalling specific lots of Panera Bread at Home Chicken Tortilla Soup due to possible plastic contamination. No illnesses have been reported.

    Product
    Blount Fine Foods Corp. — Blount Fine Foods Recalls Soup with Chicken Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-1275-2019·2019-05-22

    Ethicon Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH21A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1340-2019·2019-05-22

    Schiff Foods Recalls Jalapeno Powder Due to Salmonella Risk

    Schiff Foods Products is recalling 50 lb. boxes of Jalapeno Powder because the product was found to contain Salmonella. The recall covers domestic and international distribution.

    Product
    Schiff Food, Jalapeno Powder, 50 lb. box
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1292-2019·2019-05-22

    Titanium 4000 capsules recalled for undeclared sildenafil and tadalafil

    D.B.P. Distribution is recalling Titanium 4000 capsules because they contain undeclared sildenafil and tadalafil and were marketed without an approved NDA or ANDA.

    Product
    Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1273-2019·2019-05-22

    Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery is recalling 434,614 endoscopic curved intraluminal staplers because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1281-2019·2019-05-22

    Preferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

    Preferred Pharmaceuticals is recalling Losartan Potassium 50mg tablets because FDA testing found an impurity above acceptable levels.

    Product
    Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·19V384000·2019-05-22

    Newmar Recalls 2019 Motorhomes Due to Loose Brake Caliper Bolts

    Newmar is recalling 2019 Mountain Aire and Essex motorhomes because loose brake caliper mounting bolts may reduce brake effectiveness and increase crash risk.

    Product
    NEWMAR — NEWMAR ESSEX, MOUNTAIN AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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