Recalls in Hawaii (page 4)
3886 recalls.
- Vinyl Instrument Guards recall (Healthmark Industries Co., Inc.)
Medical deviceClass IIReported October 21, 2026 · Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. - IntelePACS recall (INTELERAD MEDICAL SYSTEMS INCORPORATED)
Medical deviceClass IIReported October 21, 2026 · Following a Chromium-based web-browser, report and displayed images may not match. - Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY... recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during... - Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC ... recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during... - Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY ... recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during... - Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI ... recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during... - Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC... recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during... - Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC ... recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during... - Medline surgical convenience kits labeled as: 1) SPINAL CDS recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: OPEN HEART recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: 1) EAR recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: VEIN HARVESTING PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: 1) OPEN HEART CDS recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - 1) Product Name AUD OPEN HEART PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - Medline surgical convenience kits labeled as: CABG AUXILIARY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported October 21, 2026 · Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to... - LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. recall (Magellan Diagnostics, Inc.)
Medical deviceClass IIIReported October 21, 2026 · In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct... - MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control recall (Microgenics Corporation)
Medical deviceClass IIReported October 21, 2026 · Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone... - Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis recall (W L Gore & Associates, Inc.)
Medical deviceClass IIReported October 21, 2026 · The potential for the devices to be mislabeled with the incorrect length. - RAPICIDE PA Part A High-Level Disinfectant recall (Steris Corporation)
Medical deviceClass IIReported October 21, 2026 · If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid... - RAPICIDE PA Part A High-Level Disinfectant recall (Steris Corporation)
Medical deviceClass IIReported October 21, 2026 · If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid... - RAPICIDE PA Part A High-Level Disinfectant recall (Steris Corporation)
Medical deviceClass IIReported October 21, 2026 · If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid... - PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture recall (Ethicon, LLC)
Medical deviceClass IIReported October 21, 2026 · Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that... - FORWARD Gunshot Wound Kit recall (INTEGRATED MEDCRAFT LLC)
Medical deviceClass IIReported October 21, 2026 · Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the... - Power F2 Powered Fastening System recall (Ferno-Washington Inc)
Medical deviceClass IIReported October 21, 2026 · Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system... - Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack recall (Sarnova HC, Llc)
Medical deviceClass IIReported October 21, 2026 · Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula. - NaviFlex LW Pusher recall (Boston Scientific Corporation)
Medical deviceClass IIReported October 21, 2026 · Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this... - NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number... recall (Neuronetics, Inc.)
Medical deviceClass IIReported October 21, 2026 · Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. - Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number:... recall (Cadwell Industries Inc)
Medical deviceClass IIReported October 21, 2026 · Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the... - BD Phoenix Panel NMIC-306. Catalog Number: 449292. recall (Becton Dickinson & Co.)
Medical deviceClass IIReported October 21, 2026 · Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. - BD Phoenix Panel NMIC-312. Catalog Number: 449082. recall (Becton Dickinson & Co.)
Medical deviceClass IIReported October 21, 2026 · Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. - Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined... recall (Medtronic Sofamor Danek USA Inc)
Medical deviceClass IIReported October 21, 2026 · Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to... - Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined... recall (Medtronic Sofamor Danek USA Inc)
Medical deviceClass IIReported October 21, 2026 · Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related... - JenaValve Trilogy Delivery Catheter recall (Jenavalve Technology Inc.)
Medical deviceClass IIReported October 21, 2026 · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. - JenaValve Trilogy Delivery Catheter recall (Jenavalve Technology Inc.)
Medical deviceClass IIReported October 21, 2026 · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. - JenaValve Trilogy Delivery Catheter recall (Jenavalve Technology Inc.)
Medical deviceClass IIReported October 21, 2026 · Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. - HemoslL AcuStar HIT-lgG recall (Instrumentation Laboratory)
Medical deviceClass IReported October 21, 2026 · Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. - HemoslL AcuStar HIT-lgG recall (Instrumentation Laboratory)
Medical deviceClass IReported October 21, 2026 · Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. - usOpal Recalls Xalirium Portable Bed Rails Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails
Consumer productReported October 15, 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... - Primark Recalls 101 Dalmatians Faux Leather Children’s Coin Purses Due to Phthalate Levels and Risk of Ingestion
Consumer productReported October 15, 2026 · The coin purses contain higher phthalate concentration levels. Phthalates can be harmful if young children are exposed to sufficient amounts, including through... - Papablic, of USA Recalls Convertible Bedside Sleepers Due to Risk of Serious Injury or Death from Entrapment, Suffocation and Fall Hazards; Violate Mandatory Standard for Play Yards
Consumer productReported October 15, 2026 · The bedside sleepers with play yard extensions violate the mandatory safety standard for play yards because the mattress can become displaced, causing a baby... - Loving Thyself Rocks Recalls Crystal Glass Cups Due to Risk of Serious Injury from Ingestion and Laceration Hazards
Consumer productReported October 15, 2026 · Glass can break inside the recalled cups while in use, posing a risk of serious injury from ingestion and laceration hazards. - HatsanUSA Recalls Blitz Air Rifles Due to Risk of Serious Injury or Death from Projectile Hazard
Consumer productReported October 15, 2026 · The recalled air rifles can fire unexpectedly when releasing the bolt before the air rifle is fully cocked, posing a risk of serious injury or death from... - 3M Company Recalls Scotch™ Thermal Laminators Due to Risk of Serious Injury or Death from Fire Hazard
Consumer productReported October 15, 2026 · The recalled thermal laminators can overheat, posing a fire hazard. - 28 oz. Gatorade Lemon Lime recall (Pepsico Inc)
FoodClass IIReported October 14, 2026 · Undeclared Yellow No. 6 and/or Yellow No. 5 - SEDIPLAST recall (POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC)
Medical deviceClass IIReported October 14, 2026 · During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube... - Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station recall (Nihon Kohden America LLC)
Medical deviceClass IIReported October 14, 2026 · Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized... - Battle Bandage recall (Safeguard US Operating LLC)
Medical deviceClass IIReported October 14, 2026 · Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and... - Spectral CT and Spectral CT 7500 RT recall (PHILIPS MEDICAL SYSTEMS)
Medical deviceClass IIReported October 14, 2026 · Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended... - Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC. Product... recall (SWEET SENSI)
FoodClass IIReported October 14, 2026 · Staphylococcus aureus detected in product. - biQ-FEL recall (A&P CREATIONS)
FoodClass IReported October 14, 2026 · Product contains undeclared Sildenafil and Tadalafil. - X10 Natural Enhancement Supplement recall (A&P CREATIONS)
FoodClass IReported October 14, 2026 · Product contains undeclared Sildenafil and Tadalafil. - Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black... recall (GIAS FOOD INC.)
FoodClass IReported October 14, 2026 · Contamination with Listeria monocytogenes - Berlin Seeds Alfalfa Sprouting Seeds recall (Berlin Seeds)
FoodClass IReported October 14, 2026 · Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination. - Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5... recall (The Better Bakehouse Snack Company)
FoodClass IReported October 14, 2026 · Undeclared Milk. - Tri-Immune Boost recall (Centric Compounding LLC)
DrugNot Yet ClassifiedReported October 14, 2026 · Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. - Apothecary NAD+ Injection 200 mg/mL recall (Apothecary Pharma LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Tirzepatide Injection recall (Apothecary Pharma LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Tretinoin Cream UPS recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIIReported October 14, 2026 · Failed Impurities/Degradation Specifications - Tretinoin Cream USP recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIIReported October 14, 2026 · Failed Impurities/Degradation Specifications - Tretinoin Cream USP recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIIReported October 14, 2026 · Failed Impurities/Degradation Specifications - Tri-MIX recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - Tri-MIX recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - Tri-MIX recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to processing equipment used in compounded product. - Tri-MIX recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to processing equipment used in compounded product. - Tri-MIX recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to processing equipment used in compounded product. - Tri-MIX recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to processing equipment used in compounded product. - QUAD-MIX recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to processing equipment used in compounded product. - SERMORELIN ACETATE 1 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - SEMAGLUTIDE 3 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - TIRZEPATIDE 26 MG/ML INJECTABLE recall (Carolina Infusion, LLC)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. - Fosfomycin Tromethamine Granules for Oral Solution recall (Cipla USA, Inc.)
DrugClass IIReported October 14, 2026 · Failed Impurities/Degradation Specifications - Lidocaine Ointment USP recall (Preferred Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Failed Content Uniformity Specifications - Sterile High Performance Ultra Lubricating Eye Drops recall (K.C. Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Sterile Eye Drops Redness Relief recall (K.C. Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Sterile Eye Drops recall (K.C. Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Sterile Lubricant Dry Eye Relief Eye Drops recall (K.C. Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Eye Drops MAXIMUM recall (K.C. Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Sterile EYE DROPS Advanced Relief recall (K.C. Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Sterile EYE DROPS AC recall (K.C. Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Artificial Tears Sterile Lubricant Eye Drops recall (K.C. Pharmaceuticals, Inc.)
DrugClass IIReported October 14, 2026 · Lack of Assurance of Sterility - Intellijoint Navigation System: Workstation G2 Configured recall (Intellijoint Surgical, Inc.)
Medical deviceClass IIReported October 14, 2026 · A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro... - HexaVue Focus Integration System recall (Steris Corporation)
Medical deviceClass IIReported October 14, 2026 · A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images... - TufTex¿ Over-the-Wire Embolectomy Catheter recall (LeMaitre Vascular, Inc.)
Medical deviceClass IIReported October 14, 2026 · Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. - T1 Patient Monitor. Operator's Manual: T1 Patient Monitor recall (Mindray DS USA, Inc.)
Medical deviceClass IIIReported October 14, 2026 · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12 recall (Mindray DS USA, Inc.)
Medical deviceClass IIIReported October 14, 2026 · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V recall (Mindray DS USA, Inc.)
Medical deviceClass IIIReported October 14, 2026 · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - BeneView Series. Operator's Manuals: T5 / T8 recall (Mindray DS USA, Inc.)
Medical deviceClass IIIReported October 14, 2026 · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama... recall (Mindray DS USA, Inc.)
Medical deviceClass IIIReported October 14, 2026 · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions - BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80 recall (Mindray DS USA, Inc.)
Medical deviceClass IIIReported October 14, 2026 · Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions