Recalls in 2022
By month
Drugs & medical recalls in the United States in 2022
- 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
- 2022-12-21
- US
Cordis US Corp recalls Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
There is a potential for separation at the male connector.
FDA · DeviceCordis US CorpNationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV,…Official notice → - US
Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
FDA · DeviceElekta, Inc.Distribution US nationwide, including Puerto Rico. There was no…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the…
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿…Official notice → - US
DeRoyal Industries Inc recalls DeRoyal MYELOGRAM PACK, REF 89-9304.05
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FDA · DeviceDeRoyal Industries IncUS: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts,…Official notice → - US
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK CSM, REF 89-6863
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
FDA · DeviceDeRoyal Industries IncUS: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts,…Official notice → - US
NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of…
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the…
FDA · DeviceNuVasive Specialized Orthopedics, Inc.Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New…Official notice → - US
Stradis Medical, LLC dba Stradis Healthcare recalls HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS nationwide distribution, and Canada.Official notice → - US
Ethicon, Inc. recalls PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use…
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
FDA · DeviceEthicon, Inc.International (OUS) only: Canada, Japan, Australia and New ZealandOfficial notice → - US
Stryker Medical Division of Stryker Corporation recalls Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.
FDA · DeviceStryker Medical Division of Stryker CorporationWorldwide Distribution: US (Nationwide) and Foreign to countries of:…Official notice → - US
Allison Medical, Inc. recalls CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
- US
Leica Microsystems, Inc. recalls Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific…
- US
ConMed Corporation recalls Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187
Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could…
FDA · DeviceConMed CorporationDomestic distribution nationwide. Foreign distribution to Colombia, Ecuador,…Official notice → - US
Becton Dickinson & Co. recalls BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for…
FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of Canada, India,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use:…
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.Official notice → - US
Zimmer, Inc. recalls NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial…
- US
ARROW INTERNATIONAL Inc. recalls Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.