DrugMay 30, 2018
Milbar Laboratories T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 recall — FDA D-0832-2018
Subpotent
Class IIIFDA: TerminatedMilbar Laboratories, Inc.
May 2018 recalls — page 3
These records include useful source details for the selected month.
DrugMay 30, 2018
Mylan Institutional Loxapine Capsules, USP 50 mg recall — FDA D-0823-2018
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class IIFDA: TerminatedMylan Institutional, Inc. (d.b.a. UDL Laboratories)
DrugMay 30, 2018
Ideaz screamin' hot (capsaicin) Pain Relieving Gel, 0.03% recall — FDA D-0834-2018
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Class IIFDA: TerminatedIdeaz LLC
VehicleMay 25, 2018
Jeep Cherokee engine recall — NHTSA campaign 18V344000
Chrysler (FCA US LLC) is recalling certain 2019 Jeep Cherokee vehicles equipped with 2.0L engines. The engines in these vehicles may be missing valve stem keepers, which can allow the valve…
engineChrysler (FCA US LLC)
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm recall — FDA Z-1814-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm recall — FDA Z-1817-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
Micro Therapeutics Inc., Dba Ev3 Neurovascular MindFrame Capture LP Revascularization recall — FDA Z-1701-2018
There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
Class IFDA: TerminatedMicro Therapeutics Inc., Dba Ev3 Neurovascular
Medical DeviceMay 23, 2018
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The recall — FDA Z-1812-2018
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceMay 23, 2018
Siemens Medical Solutions USA SOMATOM Force (Model 10742326) Computed tomography x-ray recall — FDA Z-1748-2018
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC BOX1073076GASB1 BBR GASTRIC BYPASS S recall — FDA Z-1828-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision recall — FDA Z-1881-2018
A failure of the tube arm suspension is possible while the tube arm height is being adjusted. During tube height adjustment there is a small probability of failure of both the primary and…
Class IIFDA: TerminatedVisaris DOO
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX recall — FDA Z-1829-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC (1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT recall — FDA Z-1843-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo recall — FDA Z-1833-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% recall — FDA Z-1804-2018
Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC) for antimicrobial agents Cefaclor (Ctr) and Penicillin (P) with control organism…
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA recall — FDA Z-1844-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061 recall — FDA Z-1826-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC (1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX recall — FDA Z-1849-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014 recall — FDA Z-1803-2018
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are…
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC (1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 recall — FDA Z-1842-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC MGBX ZESTAW GB LS X1 Product Usage: The Endo GIA universal and Endo GIA recall — FDA Z-1850-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
Medical DeviceMay 23, 2018
Ethicon Endo-Surgery 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with recall — FDA Z-1885-2018
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute…
Class IIFDA: TerminatedEthicon Endo-Surgery Inc.
Medical DeviceMay 23, 2018
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M recall — FDA Z-1802-2018
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are…
Class IIFDA: TerminatedBard Peripheral Vascular Inc.
Medical DeviceMay 23, 2018
COVIDIEN MEDTRONIC Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm recall — FDA Z-1820-2018
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding…
Class IIFDA: TerminatedCOVIDIEN MEDTRONIC
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.