Recalls in Puerto Rico (page 24)
3814 recalls.
- Superbobi Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Manufactured by Remy&shop
Consumer productReported May 15, 2026 · The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and... - Minka Lighting Group Recalls Bardon Series Pendant Light Fixtures Due to Risk of Serious Injury or Death from an Impact Hazard
Consumer productReported May 15, 2026 · The recalled light fixture's frame can detach from the pendant downrod during installation, posing a risk of serious injury or death from an impact hazard. - ERBEFLO 2 recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources recall (Erbe Medical, LLC)
Medical deviceClass IIReported May 13, 2026 · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible... - Woodstock Organic Shelled Edamame 10 oz. and 48 oz. recall (Green Organic Vegetables)
FoodClass IIReported May 13, 2026 · Foreign object: metal pieces - Lactated Ringer's Injection USP recall (B BRAUN MEDICAL INC)
DrugClass IReported May 13, 2026 · Presence of Particulate Matter. - NAPROXEN ORAL SUSPENSION recall (Acella Pharmaceuticals, LLC)
DrugClass IIReported May 13, 2026 · Chemical contamination; presence of lead and lithium above specification - Duloxetine Delayed-Release Capsules USP recall (Breckenridge Pharmaceutical, Inc.)
DrugClass IIReported May 13, 2026 · CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - Enalapril Maleate Tablets recall (JB Chemicals and Pharmaceuticals Ltd)
DrugClass IIReported May 13, 2026 · Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test - Octreotide Acetate for Injectable Suspension recall (Teva Pharmaceuticals USA, Inc)
DrugClass IIReported May 13, 2026 · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract... - BD PurPrep recall (CareFusion 213, LLC)
DrugClass IIReported May 13, 2026 · Lack of assurance of Sterility: potential product contamination - BD PurPrep recall (CareFusion 213, LLC)
DrugClass IIReported May 13, 2026 · Lack of assurance of Sterility: potential product contamination - Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability... - Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability... - Duloxetine Delayed-Release Capsules recall (Ajanta Pharma Ltd.)
DrugClass IIReported May 13, 2026 · CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability... - DELFLEX recall (Fresenius Medical Care Holdings, Inc.)
DrugClass IIReported May 13, 2026 · Lack of Assurance of Sterility: Potential leaks from perforations in bags. - DELFLEX recall (Fresenius Medical Care Holdings, Inc.)
DrugClass IIReported May 13, 2026 · Lack of Assurance of Sterility: Potential leaks from perforations in bags. - busPIRone Hydrochloride Tablets recall (Unichem Pharmaceuticals USA Inc.)
DrugClass IIIReported May 13, 2026 · Subpotent drug - ZENBONE recall (Orthorebirth Co Ltd)
Medical deviceClass IIReported May 13, 2026 · Resorbable bone void filler falls outside standard specifications. - BioCera Fibers recall (Orthorebirth Co Ltd)
Medical deviceClass IIReported May 13, 2026 · Resorbable bone void filler falls outside standard specifications. - Medline Surgical Packs: 1) PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See complete list in RES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Surgical Drapes: 1) SHEET recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ARTHROSCOPY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT UROLOGY SLING recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LVAD DRIVELINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAPE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DRAPE PACK-CHOICE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT GENERAL CLOSURE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BURN PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) WMC I D PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) HYSTEROSCOPY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) C-SECTION PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See full list in RES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) OB KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) NEURO SHUNT- CODMAN recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ADMIT KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PPE KIT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) CVC PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) LITHOTOMY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) DYNDA3003 recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) PICC LINE TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANGIO PROCEDURE PACK recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) SCC RF PAIN MGMT recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - Medline Convenience Kits: 1) ANCILLARY PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported May 13, 2026 · Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated... - One Step P in vitro diagnostic test REF: 8194 recall (DFI Co., Ltd.)
Medical deviceClass IIReported May 13, 2026 · The devices were distributed without required FDA premarket clearance or approval. - 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. - LIFEPAK 15 recall (Physio-Control, Inc.)
Medical deviceClass IIReported May 13, 2026 · Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was... - Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module ... recall (Spacelabs Healthcare, Inc.)
Medical deviceClass IIReported May 13, 2026 · Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). - 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... - Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported May 13, 2026 · Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. - 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...