Recalls in 2022
By month
Drugs & medical recalls in 2022
- 2022-12-30
CA- CA
- CA
- CA
- CA
- 2022-12-28
USTomy International Inc. recalls Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness…
FDA · DeviceTomy International Inc.Worldwide distribution - US Nationwide and the countries of Canada, Australia,…Official notice →- US
Medical Action Industries, Inc. 306 recalls Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box,…
Scissors contained debris.
FDA · DeviceMedical Action Industries, Inc. 306Distribution was made to FL, IL, IN, MA, MD, MO, OH, and VA. There was no…Official notice → - US
Baxter Healthcare Corporation recalls Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice → - US
Baxter Healthcare Corporation recalls Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by…
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution. US Nationwide including Guam and St. Thomas USVI;…Official notice → - US
GE Medical Systems, LLC recalls Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes,…
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
FDA · DeviceGE Medical Systems, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Medical Action Industries, Inc. 306 recalls Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
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FDA · DeviceMedical Action Industries, Inc. 306US Nationwide distribution in the state of VA.Official notice → - US
Heartware, Inc. recalls HeartWare Model 1100
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which…
- US
Companion Medical, Inc. recalls InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA,…
Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating…
FDA · DeviceCompanion Medical, Inc.US Nationwide distribution including in the states of CA, NY, MT, OH, IN, MN,…Official notice → - US
Abbott Molecular, Inc. recalls Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- US
NuVasive Inc recalls X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
FDA · DeviceNuVasive IncWorldwide - U.S. Nationwide distribution including in the states of NC, CA,…Official notice → - US
Howmedica Osteonics Corp. recalls Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:…
Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of Turkey.Official notice → - US
Natus Medical Incorporated recalls The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to…
Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and…
FDA · DeviceNatus Medical IncorporatedU.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID,…Official notice → - US
Fresenius Medical Care Holdings, Inc. recalls 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare…
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false…
- US
GE Medical Systems, LLC recalls B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,
GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that…
- US
Icotec Ag recalls VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring…
- US
Corin Ltd recalls Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
FDA · DeviceCorin LtdUS Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.Official notice → - US
Young Dental Manufacturing I, LLC recalls Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
mislabeled product
FDA · DeviceYoung Dental Manufacturing I, LLCWorldwide distribution - US Nationwide distribution in the states of IA, NY,…Official notice → - US
DeVilbiss Healthcare LLC recalls DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius…
- US
ConvaTec, Inc recalls ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
- US
GE Medical Systems, LLC recalls Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in…
FDA · DeviceGE Medical Systems, LLCNationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND,…Official notice → - US
- US
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin…
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
FDA · DrugLupin Pharmaceuticals Inc.Product was distributed by major distribution chains nationwide.Official notice → - US
Aurolife Pharma, LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC…
Failed Impurities/Degradation Specifications
- US
- 2022-12-23
- CA
- CA
- CA
- CA
AUAccu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit
If insulin is under-delivered, this may lead to adverse health events including severe hyperglycaemia or the user may experience diabetic ketoacidosis (DKA) and may require hospitalisation or intervention from a…
- 2022-12-22
- CA
99.0 % Oxygen USP - Gas cylinders containing commercial grade oxygen
Product quality
Health CanadaOfficial notice → - CA
- CA
Nexgen Complete Knee Solution Stemmed Non-Augment Tibial Comp (Cr/Ps) Option
Performance
Health CanadaOfficial notice → - CA
- CA
- CA