Recalls in New Hampshire (page 34)
3892 recalls.
- JJGoo LED Balloon Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries
Consumer productReported February 19, 2026 · The recalled lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain button cell batteries... - Joly's Recalls 80% Vinegar Due to Risk of Serious Injury or Death from Poisoning and Chemical Burns; Violates FHSA Labeling Requirements
Consumer productReported February 19, 2026 · The recalled vinegar product violates the precautionary labeling requirements under the Federal Hazardous Substances Act (FHSA) because the hazardous substance... - Huaker Magnetic Balls and Rods Sets Recalled Due to Risk of Serious Injury or Death from Choking; Violates the Small Ball Ban
Consumer productReported February 19, 2026 · The recalled magnet toy building sets violate the mandatory standard for toys because they contain small balls and are intended for children under three years... - Vive Health Recalls Adult Portable Bed Rails Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails
Consumer productReported February 19, 2026 · The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped... - ATEC Lateral Navigation Disc Prep Instruments LIF NAV recall (Alphatec Spine, Inc.)
Medical deviceClass IIReported February 18, 2026 · Due a design issue where the navigated array connection geometry is incorrect. - ATEC Lateral Navigation Disc Prep Instruments LIF NAV recall (Alphatec Spine, Inc.)
Medical deviceClass IIReported February 18, 2026 · Due a design issue where the navigated array connection geometry is incorrect. - UDENYCA recall (McKesson)
DrugClass IReported February 18, 2026 · Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the... - Cetrorelix Acetate for Injection recall (Meitheal Pharmaceuticals, Inc)
DrugClass IIReported February 18, 2026 · Defective Delivery System: Missing or duplicated needles within the injection kit - Oxycodone Hydrochloride Tablets recall (Amerisource Health Services LLC)
DrugClass IIReported February 18, 2026 · Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. - vancomycin HCl recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - vancomycin HCl recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - thiamine HCl recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - ketamine HCl recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - acyclovir sodium recall (Fresenius Kabi Compounding, LLC)
DrugClass IIReported February 18, 2026 · Lack of Assurance of Sterility - Testosterone 100mg Anastrozole 4mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 87.5mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 200mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 100mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 75mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone 100mg recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Testosterone recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - ESTRADIOL recall (F.H. INVESTMENTS, Inc. (dba Asteria Health))
DrugClass IIReported February 18, 2026 · Presence of Foreign substance - potential presence of metal particulate matter - Doxazosin Tablets recall (Unichem Pharmaceuticals USA Inc.)
DrugClass IIIReported February 18, 2026 · Tablets/Capsules Imprinted with Wrong ID - Pro Numb Tattoo Numbing Spray recall (Pro Numb Tattoo Numbing Spray LLC)
DrugClass IIReported February 18, 2026 · cGMP deviations - Pro Numb Tattoo Numbing Spray recall (Pro Numb Tattoo Numbing Spray LLC)
DrugClass IIReported February 18, 2026 · cGMP deviations - da Vinci 5 Surgeon Console Viewer Display recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported February 18, 2026 · Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth... - Azurion 5 M20 System Model Numbers: recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported February 18, 2026 · Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. - Azurion 5 M12 System Model Numbers: recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported February 18, 2026 · Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. - Azurion 7 M20 System Model Numbers: recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported February 18, 2026 · Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. - Azurion 7 M12 System Model Numbers: recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported February 18, 2026 · Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. - Azurion 7 B20 System Model Numbers: recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported February 18, 2026 · Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. - Azurion 7 B12 System Model Numbers: recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported February 18, 2026 · Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. - Azurion 3 M15 System Model Numbers: recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported February 18, 2026 · Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. - Azurion 3 M12 System Model Numbers: recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported February 18, 2026 · Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active. - Laerdal Compact Suction Unit 4 RTCA version recall (Laerdal Medical Corporation)
Medical deviceClass IIReported February 18, 2026 · units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter... - Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system... recall (Elekta, Inc.)
Medical deviceClass IIReported February 18, 2026 · Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This... - Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system... recall (Elekta, Inc.)
Medical deviceClass IIReported February 18, 2026 · Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This... - Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. recall (AVID Medical, Inc.)
Medical deviceClass IIReported February 18, 2026 · Tyvek bag seal issue which may compromise sterility of the kit. - WB Impression Post Closed Tray incl. guide screw recall (Straumann USA LLC)
Medical deviceClass IIIReported February 18, 2026 · The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. - Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: STERILE RESUTURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - 1) UNIVERSAL KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: ADULT CATH SECUREMENT DRSG recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may... - Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: ... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: ... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes... recall (Medline Industries, LP)
Medical deviceClass IReported February 18, 2026 · These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response... - Spectral CT 7500 on Rails recall (Philips North America Llc)
Medical deviceClass IIReported February 18, 2026 · As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners... - Spectral CT recall (Philips North America Llc)
Medical deviceClass IIReported February 18, 2026 · As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners... - IQon Spectral CT recall (Philips North America Llc)
Medical deviceClass IIReported February 18, 2026 · As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners... - Brilliance iCT recall (Philips North America Llc)
Medical deviceClass IIReported February 18, 2026 · As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners... - Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. recall (Hologic, Inc)
Medical deviceClass IIReported February 18, 2026 · Presence of particulates in affected devices that can be deposited into breast tissue during use. - Intubation Tray recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the... - Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit recall (Medline Industries, LP)
Medical deviceClass IIReported February 18, 2026 · A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the... - Watkins Manufacturing Recalls Hydromassage Rotary Jets in Highlife Collection Spas Due to Entanglement and Drowning Hazards
Consumer productReported February 13, 2026 · The hydromassage rotary jets can create a suction force that allows the user's hair to be entangled, submerging their head underwater, posing entanglement and... - Beloems Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails
Consumer productReported February 13, 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... - CheerKid Baby Bath Seats Recalled Due to Risk of Serious Injury or Death to Children from Drowning; Violates Mandatory Standard for Infant Bath Seats; Sold on Amazon by Babibaby and Woot
Consumer productReported February 13, 2026 · The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious... - Surveying Accessories Cheaper Recalls Board Games Due to Risk of Serious Injury or Death from Magnet Ingestion; Violates Mandatory Standard for Toys
Consumer productReported February 13, 2026 · The recalled board games violate the mandatory standard for toys because the magnetic game pieces contain loose high-powered magnets, posing an ingestion... - Fortemotus Direct Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails
Consumer productReported February 13, 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... - SOOWERY 6-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violates Mandatory Standard for Clothing Storage Units
Consumer productReported February 12, 2026 · The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or... - LShome Photoelectric Smoke Detector Fire Alarms Recalled Due Failure to Warn During Fire Posing Serious Injury or Death Hazard; Sold Exclusively on Amazon.com by TIANJINSHIHAOWEIXINSHENGJIDIANANZHUANGGONGCHENG
Consumer productReported February 12, 2026 · If the sensing threshold of security warnings is set too high, the alarm might not sound in a timely manner, posing a fire hazard. - DriBiz Recalls Ammo Tabs Desiccant Tiles Due to Injury Hazard
Consumer productReported February 12, 2026 · The Ammo Tab can fail to protect the firearms and ammunition from humidity, allowing excess moisture to cause corrosion or rust that can increase the risk of... - Airova Recalls Aroeve Air Purifiers Due to Fire and Burn Hazards
Consumer productReported February 12, 2026 · The air purifiers can overheat and ignite, posing fire and burn hazards to consumers. - Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. recall (Imu-Tek Animal Health, Incorporated)
FoodClass IIReported February 11, 2026 · Undeclared milk allergen - FDR Visionary Suite recall (FUJIFILM Healthcare Americas Corporation)
Medical deviceClass IIReported February 11, 2026 · It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might... - Product Name: Single Use 3-Lumen Sphincterotome V recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance. - Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520... recall (Olympus Corporation of the Americas)
Medical deviceClass IIReported February 11, 2026 · Devices which did not undergo thermoforming could deform and lose performance.