Recalls in Washington (page 26)
4037 recalls.
- One Step K in vitro diagnostic test REF: 81A4 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - Uric Acid in vitro diagnostic test REF: 31H0P recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step pH in vitro diagnostic test REF: 31I4P recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step UTI in vitro diagnostic test REF: 3374 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - One Step 10A in vitro diagnostic test recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported May 13, 2026 · Respiratory/sore throat panel test may result in false negative results and control failures. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining... - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - DEX Ophthalmic Tissue Forceps recall (Katalyst Surgical, LLC)
Medical deviceClass IIReported May 13, 2026 · Field Safety Corrective Action for IFU in DEX Forceps and Scissors. - Mint Lesion recall (Mint Medical GmbH)
Medical deviceClass IIReported May 13, 2026 · If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be... - BioFire Joint Infection recall (BioFire Diagnostics, LLC)
Medical deviceClass IIReported May 13, 2026 · Contamination to in-vitro diagnostic test may result in false positives. - Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical... recall (Centinel Spine, Inc.)
Medical deviceClass IIReported May 13, 2026 · Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was... - Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc... recall (Centinel Spine, Inc.)
Medical deviceClass IIReported May 13, 2026 · Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was... - LUX-Dx II Plus recall (Boston Scientific Corporation)
Medical deviceClass IIReported May 13, 2026 · For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or... - LUX-DX II recall (Boston Scientific Corporation)
Medical deviceClass IIReported May 13, 2026 · For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or... - Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 ... recall (Cook Incorporated)
Medical deviceClass IReported May 13, 2026 · Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated... - Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 ... recall (Cook Incorporated)
Medical deviceClass IReported May 13, 2026 · Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated... - Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters... recall (Cook Incorporated)
Medical deviceClass IReported May 13, 2026 · Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated... - EVLWZL and Gunugu Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violates Mandatory Standard for Mattress Flammability
Consumer productReported May 7, 2026 · The mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire. - Allura Imports Recalls Youth Sweatshirts with Bobcat Logo and Drawstrings Due to Risk of Serious Injury or Death from Strangulation Hazard; Violates Federal Regulations for Children's Upper Outerwear
Consumer productReported May 7, 2026 · The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children from strangulation. The sweatshirts are in... - Analemma Water Bottles Recalled Due to Risk of Serious Injury or Death from Laceration and Ingestion Hazards; Imported by New Earth Technologies d.o.o.
Consumer productReported May 7, 2026 · The recalled water bottle's inner glass liner can break, posing a risk of serious injury or death from laceration and ingestion hazards. - Rainbow Wall Toys Recalled Due to Risk of Serious Injury or Death from Choking Hazard; Violate Mandatory Standard for Children's Toys; Sold on Amazon by Justforjoyful
Consumer productReported May 7, 2026 · The recalled toys violate the mandatory safety standard for children's toys because the drumstick that is attached to the xylophone component has a spherical... - Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicycle Helmets; Sold on Temu by Foubeaka and Geniuss
Consumer productReported May 7, 2026 · The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stability and... - Natural Pigments Recalls Rublev Colours Gum Turpentine and Mineral Spirits Bottles Due to Risk of Serious Injury or Death from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging
Consumer productReported May 7, 2026 · The gum turpentine and mineral spirits contain turpentine and low-viscosity hydrocarbons, respectively, which must be in child-resistant packaging, as required... - Svnntaa Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation Hazards; Violates Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Eokeanon
Consumer productReported May 7, 2026 · The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed... - Favoto Bicycle Helmets Recalled Due to Risk of Serious Head Injury; Violate Mandatory Standard for Bicycle Helmets; Sold on Amazon by Favoto
Consumer productReported May 7, 2026 · The recalled helmets violate the mandatory safety standard for bicycle helmets because they do not comply with the positional stability, labeling and... - ZMC Group Recalls Multiple Light Up Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys
Consumer productReported May 7, 2026 · The recalled toys violate the mandatory safety standard for children's toys because the toy contains button cell batteries that can be easily accessed by... - EEMB USA Recalls Battery Pouches Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Federal Statute for Child-Resistant Packaging of Coin Batteries
Consumer productReported May 7, 2026 · The lithium coin batteries are in pouches that are not child-resistant as required under Reese's Law. If a child swallows button cell or coin batteries, the... - Brand Name: Leksell Vantage Arc System REF: 1053958 recall (Elekta, Inc.)
Medical deviceClass IIReported May 6, 2026 · Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. - Immy recall (Immuno-Mycologics, Inc)
Medical deviceClass IIReported May 6, 2026 · Neutralization Buffer may contain contaminants - Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak ... recall (Advanced Bionics, LLC)
Medical deviceClass IIReported May 6, 2026 · The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the... - AIDBAGs are first aid kits of convenience composed of individually labeled devices... recall (North American Rescue LLC.)
Medical deviceClass IReported May 6, 2026 · Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5... - Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and... recall (Zimmer, Inc.)
Medical deviceClass IIReported May 6, 2026 · Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or... - Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery... recall (Clinical Innovations, LLC)
Medical deviceClass IIReported May 6, 2026 · Due to complaints of device breakage at the traction force gauge to handle joint. - Calypso Tropic Tango Lemonade. 16 FL oz recall (King Juice Company, Inc.)
FoodClass IIReported May 6, 2026 · Product contains undeclared Yellow No. 5. - My Mochi Strawberry flavored Non-Dairy Frozen Dessert recall (The Mochi Ice Cream Company, LLC)
FoodClass IIReported May 6, 2026 · Foreign object found inside retail container. - Alendronate Sodium Oral Solution recall (Hikma Pharmaceuticals USA INC)
DrugClass IIReported May 6, 2026 · This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. - Lidocaine Wound Gel recall (Water-Jel Technologies, LLC)
DrugClass IIIReported May 6, 2026 · Failed PH Specifications - fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Ketamine Hydrochloride Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - fentaNYL Citrate Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Phenylephrine Hydrochloride Injectable Solution recall (Wells Pharma of Houston LLC)
DrugClass IIReported May 6, 2026 · cGMP deviations. - Similasan recall (Thea Pharma, Inc.)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. - iVIZIA recall (Thea Pharma, Inc.)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. - Optase Dry Eye Intense Drops recall (SCOPE HEALTH)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility - Levocarnitine Injection recall (American Regent, Inc.)
DrugClass IIIReported May 6, 2026 · Labeling: Missing Label - GenTeal Tears recall (Alcon Research LLC)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Systane recall (Alcon Research LLC)
DrugClass IIReported May 6, 2026 · Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. - Medline and Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline or Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline and Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Medline medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - Centurion medical convenience kits recall (Medline Industries, LP)
Medical deviceClass IIReported May 6, 2026 · Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal... - epoc BGEM BUN Test Card recall (Siemens Healthcare Diagnostics Inc)
Medical deviceClass IIReported May 6, 2026 · Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial... - Philips Bridge Prep Kit REF: K12-09098C Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - Philips Bridge Prep Kit REF: K12-09098C Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - Philips Bridge Prep Kit REF: K12-09098B Sterile EO recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported May 6, 2026 · catheter may experience resistance when being advanced over the guidewire - i-STAT G3+ cartridge recall (Abbott Point Of Care Inc.)
Medical deviceClass IIReported May 6, 2026 · Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)... - i-STAT EG6+ cartridge recall (Abbott Point Of Care Inc.)
Medical deviceClass IIReported May 6, 2026 · Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)... - i-STAT EG7+ cartridge recall (Abbott Point Of Care Inc.)
Medical deviceClass IIReported May 6, 2026 · Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26)... - Heraeus recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIIReported May 6, 2026 · Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its... - Heraeus recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIIReported May 6, 2026 · Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its... - iLet Bionic Pancreas recall (Beta Bionics, Inc.)
Medical deviceClass IIReported May 6, 2026 · insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch... - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - Depuy Synthes recall (DEPUY (IRELAND))
Medical deviceClass IIReported May 6, 2026 · The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. - BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use recall (Becton Dickinson & Co.)
Medical deviceClass IIReported May 6, 2026 · BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce... - BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use recall (Becton Dickinson & Co.)
Medical deviceClass IIReported May 6, 2026 · BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce... - Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIReported May 6, 2026 · Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the... - Philips Upgrade to MR 7700 with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips SmartPath to Ingenia Elition X with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips SmartPath to dStream for XR and 3.0T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips SmartPath to dStream for 3.0T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips SmartPath to dStream for 1.5T with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips MR 7700 with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia Elition X with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia Elition S with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia Ambition X with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading... - Philips Ingenia Ambition S with MR Elastography recall (Philips North America)
Medical deviceClass IIReported May 6, 2026 · The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading...