The Recall Desk

Archive

September 2024 recalls

704 recalls were announced in September 2024.

What the numbers show

Critical
8
Severe
103
High
393
Moderate
199
Low
1

Of the 704 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

101–200 of 704

  • SevereNHTSA·24V701000·2024-09-19

    Lamborghini Recalls 2024 Huracan Spyder for Frame Bracket Installation Error

    Lamborghini is recalling 39 2024 Huracan EVO Spyder vehicles because the right front frame bracket may be installed on the wrong side, potentially reducing crash protection.

    Product
    LAMBORGHINI — LAMBORGHINI HURACAN SPYDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24370·2024-09-19

    Ceither Adult Portable Bed Rails Recalled for Entrapment and Asphyxia Hazard

    Ceither Adult Portable Bed Rails sold on Amazon violate federal regulations and pose a serious risk of entrapment and asphyxiation. Users can become trapped within the bed rail or between the rail and mattress.

    Product
    Ceither Adult Portable Bed Rails
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24374·2024-09-19

    Polaris Model Year 2024 RANGER XD 1500 ROVs Recalled for Fire Hazard

    Polaris is recalling Model Year 2024 RANGER XD 1500 and Crew XD 1500 recreational off-road vehicles equipped with winches because the winch wiring can overheat during use, creating a fire hazard and risk of serious injury.

    Product
    Model Year 2024 RANGER XD 1500 and Crew XD 1500 Recreational Off-Road Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24371·2024-09-19

    Caframo Cabinet Heaters Recalled for Electrocution Hazard

    Caframo Limited is recalling about 2,140 model 9421 cabinet heaters sold in the U.S. because a crimp holding a wire in place is not properly finished and can detach, creating an electrocution hazard.

    Product
    Cabinet Heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V703000·2024-09-19

    Chevrolet Colorado seat belt buckle bolts may not be properly tightened

    GM is recalling certain 2023-2024 Chevrolet Colorado and 2023 GMC Canyon vehicles because a front seat belt buckle attachment bolt may not have been tightened properly.

    Product
    CHEVROLET — CHEVROLET, GMC COLORADO, CANYON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V698000·2024-09-19

    Motiv Recalls Electric Chassis Vehicles Due to Wiring Harness Defect

    Motiv Power Systems is recalling specific 2017-2023 electric chassis vehicles because a missing wiring harness component may cause a loss of drive power, increasing crash risk.

    Product
    MOTIV — MOTIV F-59 BEV CHASSIS, E-450 CHASSIS, E-450 BEV CHASSIS, F-53 BEV CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24369·2024-09-19

    Polaris Sportsman ATVs Recalled for Fuel Leak Fire Hazard

    Polaris is recalling certain Model Year 2023–2024 Sportsman 850, XP 1000, and XP 1000 S ATVs because fuel can leak at the fuel pump outlet, creating a fire hazard. The company has received 14 reports of fuel leaks and 3 reports of fire, with no injuries reported.

    Product
    Model Year 2023-2024 Polaris Sportsman 850, XP 1000, and XP 1000 S ATVs and fuel pump kits and fuel tank assemblies
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24373·2024-09-19

    Place & Time Battery-Operated Desk Lamps Recalled Due to Fire Hazard

    Jo-Ann Stores recalls about 9,700 Place & Time battery-operated desk lamps due to fire hazard from overheating battery compartments during USB charging. No injuries reported, but three incidents of battery melting or popping have been documented.

    Product
    Place & Time battery-operated desk lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24372·2024-09-19

    CVB Platform Beds with Upholstered Headboards Recalled for Fall and Injury Hazards

    About 137,000 Lucid platform beds with upholstered square tufted headboards can sag, break, or collapse during use. The manufacturer has received 245 reports of structural failure resulting in 18 reported injuries.

    Product
    Platform Beds with Upholstered Square Tufted Headboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24366·2024-09-19

    Newmemo Children's Ring Sets Recalled for Lead and Cadmium Content

    Newmemo Children's Ring Sets sold on Amazon contain unsafe levels of lead and cadmium. These toxic metals can cause adverse health effects if ingested by young children.

    Product
    Newmemo Children's Ring Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24368·2024-09-19

    Wee Gallery Baby Tummy Time Gallery Recalled for Phthalate Violation

    Wee Gallery is recalling about 8,000 Baby Tummy Time Gallery products because the clear plastic pockets contain phthalate levels that exceed federal limits. Phthalates are toxic if ingested by young children.

    Product
    Baby Tummy Time Gallery
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2972-2024·2024-09-18

    Infusomat Space Infusion Pump Recall Due to Sensor Malfunction

    B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.

    Product
    Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1547-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled for Breaking During Use

    Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3026-2024·2024-09-18

    Medline ER Suture Kits Recalled Due to Syringe Quality Issues

    Medline is recalling ER Suture Convenience Kits because the included plastic syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3053-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Syringe Quality Issues

    Medline is recalling C Scope Disposable Kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.

    Product
    Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C SCOPE DISPOSABLE KIT, Pack Code 613034701; 3) C SCOPE DISPOSABLE KIT, Pack Code 613034702
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1548-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled Due to Breakage During Use

    Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3113-2024·2024-09-18

    Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss

    Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B; b) PLASTIC MAJOR, Pack Number DYNJ908106B; c) ABDOMINOPLASTY W/LIPO SUCTION, Pack Number DYNJ909946; d) PLASTIC, Pack Number DYNJ909951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3087-2024·2024-09-18

    Smiths Medical Tracheotomy Tube Kits Recalled for Pilot Balloon Disconnection

    Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.

    Product
    smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2)…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3086-2024·2024-09-18

    Smiths Medical Tracheostomy Tubes Recalled Due to Pilot Balloon Disconnection Risk

    Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.

    Product
    smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/070CZ; 3) BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX, Item Number…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3088-2024·2024-09-18

    Smiths Medical BLUperc tracheostomy tubes recalled for pilot balloon disconnection

    Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.

    Product
    smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070; 2) BLUperc…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3108-2024·2024-09-18

    Medline Recalls Semi-Rigid Suction Liners Due to Suction Loss

    Medline Industries is recalling 19 units of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2974-2024·2024-09-18

    Pneupac ventilator control knob may shift unintentionally during operation

    Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.

    Product
    Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3024-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues

    Medline is recalling multiple convenience kits used in medical procedures due to plastic syringe defects including leaks and breakage. No injuries have been reported, but the defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1800-2024·2024-09-18

    Mochi snack recalled for missing milk and coconut allergen labels

    Orwaiian LLC is recalling Birthday Cake Mochi Crunch due to missing allergen declarations on the label. The product contains milk and coconut but these are not listed in the Contains statement.

    Product
    BDAY CAKE MOCHI CRUNCH packed in pink plastic pouch packaging, net wt. 5oz, UPC 7189147148, Orwaiian LLC, 465 NE Burnside Rd Gresham, OR 97030. The label declares "***Ingredients: Sesame Seeds, Milk Powder, Nonfat dry milk, Soy Lecithin, Coconut ***CONTAINS: Soy, Sesame…
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-3039-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Defects

    Medline Convenience kits containing defective plastic syringes are being recalled worldwide due to leaks, breakage, and quality issues that may pose patient health risks.

    Product
    Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2977-2024·2024-09-18

    HeNe laser system recalled for removable key safety control defect

    Pacific Lasertech is recalling the N-LHP-928 HeNe Laser System (35 mW) because the key-actuated safety control can be removed while the laser is operating, defeating the required master control mechanism.

    Product
    N-LHP-928, HeNe Laser System, 35 mW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3044-2024·2024-09-18

    Medline medical convenience kits recalled for syringe leaks and breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3043-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall affects kits with Pack Number DYNDH1453 distributed worldwide.

    Product
    Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3027-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline medical convenience kits containing defective plastic syringes are being recalled due to leaks, breakage, and quality issues. The affected devices have been distributed worldwide and may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT1900; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 5) PORT TRAY , Pack…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V697000·2024-09-18

    BMW and MINI vehicles brake system failure integrated module welds break

    BMW and MINI are recalling certain 2023–2025 vehicles because welds in the brake control module may break, causing loss of power brake assist, rear brakes, and stability control. This increases crash risk.

    Product
    BMW — BMW, MINI, ROLLS-ROYCE 740I, COOPER, X7, SPECTRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3028-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects

    Medline is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.

    Product
    Medline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ; 2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH; 3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ; 4) LACERATION TRAY , Pack Number DYNDL1495A ; 5) LACERATION TRAY…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3054-2024·2024-09-18

    Medline Recalls Arthroscopy Kits with Defective Plastic Syringes

    Medline Industries is recalling various arthroscopy and arthrogram convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3110-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling specific convenience kits with semi-rigid suction liners due to reported adverse events and potential loss of suction during intermittent use. Affected: 358 units distributed in US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCOPY CDS, Pack Number CDS981512J; c) OR MAJOR CDS, Pack Number CDS981515D; d) MAJOR-LF, Pack Number DYNJ900709C; e) MAJOR-LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3003-2024·2024-09-18

    Medline Breast Biopsy Kits Recalled for Syringe Quality Issues

    Medline is recalling multiple breast biopsy convenience kits with plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2981-2024·2024-09-18

    Medline Medical Convenience Kits With Defective Syringes Recalled Worldwide

    Medline recalled medical convenience kits containing plastic syringes with leaks, breakage, and quality defects. The affected syringes may pose a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3117-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Suction Loss

    Medline Industries is recalling 134 units of semi-rigid suction liners due to potential loss of suction during intermittent use. The affected kits were distributed worldwide including the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3014-2024·2024-09-18

    Medline Paracervical Pudendal Block Kits Recalled for Syringe Quality Issues

    Medline is recalling Paracervical Pudendal Block kits because the included plastic syringes have leaks, breakage, or other quality issues that may risk patient health.

    Product
    Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3104-2024·2024-09-18

    ADVIA Centaur CA 19-9 test kit recalled for measurement bias in samples

    Siemens Healthcare is recalling ADVIA Centaur CA 19-9 diagnostic test kits due to positive measurement bias in some samples. The affected kits may report falsely elevated test results, particularly around the normal limit of 35 U/mL.

    Product
    ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491244
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3111-2024·2024-09-18

    Medline Suction Liners Recalled for Potential Loss of Suction

    Medline is recalling specific lots of semi-rigid suction liners due to potential loss of suction during clinical use. The recall affects convenience kits distributed to healthcare facilities in the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pack Number DYKE1356; c) ENDOSCOPY KIT, Pack Number DYKE1771C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3119-2024·2024-09-18

    Medline Surgical Suction Kits Recalled for Potential Loss of Suction

    Medline Industries recalls specific lots of semi-rigid suction liners in C-section convenience kits due to reported adverse events. The liners may lose suction during intermittent use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3016-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Plastic Syringe Quality Issues

    Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K ; 2) CHEST EXPLORATION CDS , Pack Number CDS920066L ; 3) PLASTIC SMR CDS-LF, Pack Number CDS980088K ; 4) PLASTICS, Pack Number CDS980200AA; 5) PLASTICS, Pack Number CDS980200Y ; 6)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1801-2024·2024-09-18

    Pasta Salad Product Recalled Due to Foreign Material Contamination

    Reser's American Classics Garden Pasta Salad (UPC 71117 19063) is being recalled due to potential foreign material contamination. The recall affects 278 cases distributed to nine states.

    Product
    UPC 71117 19063, Reser's American Classics Garden Pasta Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-3064-2024·2024-09-18

    ADVIA Chemistry urinary protein reagent quality control failure

    Siemens Healthcare is recalling ADVIA Chemistry urinary protein test reagents due to potential quality control issues that could produce inaccurate patient results.

    Product
    ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3035-2024·2024-09-18

    Medline Convenience Kits with Defective Plastic Syringes Recalled

    Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The kits have been distributed worldwide.

    Product
    Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2996-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline Industries is recalling multiple convenience kits containing plastic syringes with identified quality issues including leaks and breakage. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2987-2024·2024-09-18

    Medline Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling medical convenience kits containing defective plastic syringes that may leak or break. The kits are used for epidural and spinal anesthesia procedures and have been distributed worldwide.

    Product
    Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K ; 2) EPIDURAL CSTM PACK-LF , Pack Number DYNJ0844004; 3) CUSTOM EPIDURAL PACK-LF , Pack Number DYNJ0934752F ; 4) EPIDURAL PACK-LF, Pack Number DYNJ0957053D ; 5) EPIDURAL…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3032-2024·2024-09-18

    Medline Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

    Medline has recalled convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. The recall affects multiple lot numbers distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP; 2) MSC - AHMC ANAHEIM REG MED CTR, Pack Number 148056; 3) MSC - JOHN MUIR MC, Pack Number 150206
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3061-2024·2024-09-18

    Medline Burn Packs Recalled Due to Syringe Quality Issues

    Medline is recalling burn convenience kits because they contain plastic syringes with leaks or breakage risks identified in an FDA Safety Alert.

    Product
    Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2991-2024·2024-09-18

    Medline Cardiac Pacing Kits Recalled for Syringe Quality Issues

    Medline is recalling cardiac pacing kits containing plastic syringes with leaks or breakage risks. The recall addresses quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2983-2024·2024-09-18

    Medline Medical Convenience Kits with Plastic Syringes Recalled for Quality Defects

    Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects that may pose patient health risks following an FDA Safety Alert.

    Product
    Medline Convenience kits, labeled as: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772 ; 2) ANES CIRC 90 EXP PEDS 2BV-LF, Pack Number 81842 ; 3) AIRWAY EXAM KIT, Pack Number DYKE1796 ; 4) INTUBATION KIT , Pack Number DYKSCRIPPSIN4; 5) INTUBATION KIT , Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3033-2024·2024-09-18

    Medline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage

    Medline is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects multiple syringe products distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ; 3) SYRINGE KIT , Pack Number NAM0004; 4) SYR 10ML L/S, Pack Number OEM11623 ; 5) JAPAN 3ML SYRINGE , Pack…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3097-2024·2024-09-18

    Smith & Nephew Tendon Staples Recalled for Compromised Packaging Sterility

    Smith & Nephew is recalling 2,961 units of ROTATION MEDICAL TENDON STAPLES due to improper outer foil pouch sealing that may compromise product sterility. No injuries have been reported.

    Product
    ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1798-2024·2024-09-18

    Yummy Monkey Organics Popcorn Recalled for Undeclared Milk Allergen

    Yummy Monkey Organics Real Movie Theater Popcorn is recalled because the label lists butter and ghee but fails to declare milk, a major allergen. Consumers with milk allergies should not consume this product.

    Product
    Yummy Monkey Organics Real Movie Theater Popcorn, Made With Purified Ghee & Himalayan Sea Salt. UPC 9 96692 66654 2, packaged in a Clear Polyethylene Gusseted Re-closable Bag measured 9 x 12 x 2". Net Wt. 5.25 oz (149g). Manufactured By: Yummy Monkey Organics, LLC 243 Grimes…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-3025-2024·2024-09-18

    Medline convenience kits with defective syringes recalled for quality and safety issues

    Medline is recalling medical convenience kits with plastic syringes that may leak or break, posing a risk to patient health. Worldwide distribution is affected.

    Product
    Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) MINOR ACUTE PACK-LF, Pack Number DYNJ0484979B
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2976-2024·2024-09-18

    HeNe Laser System Key Control Can Be Removed While Operating

    PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.

    Product
    25-LHP-928, HeNe Laser System, 25 mW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3114-2024·2024-09-18

    Medline semi-rigid suction liners recalled for potential suction loss

    Medline is recalling specific lots of semi-rigid suction liners from surgical convenience kits due to potential loss of suction during intermittent use. The recall affects approximately 3117 units distributed in the US, Canada, and Panama.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY, Pack Number DYKE1666; c) SUCTION CANISTER KIT, Pack Number DYKM2196; d) SUCTION CANISTER KIT, Pack Number DYKM2196H; e)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3012-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by the FDA. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O BEDSIDE KIT , Pack Number DYKE1634 ; 5) ENDO KIT, Pack Number DYKE1696…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3130-2024·2024-09-18

    Medtronic ENT Surgical Cutting Bur Distributed Past Expiration Date

    Medtronic Xomed recalled an ENT Ultra Round Steel Cutting Bur (Model REF 31313069) because it was distributed past its expiration date. This device was distributed internationally, including to Canada.

    Product
    Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3125-2024·2024-09-18

    Proton therapy system may display insufficient CBCT images during positioning

    Hitachi PROBEAT-FR proton therapy systems may display an insufficient number of CBCT images during 3D positioning when the Float Image Selection button is pressed, potentially affecting treatment planning accuracy.

    Product
    Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2984-2024·2024-09-18

    Medline medical convenience kits with defective plastic syringes recalled

    Medline is recalling medical convenience kits containing plastic syringes with identified quality defects including leaks and breakage. The worldwide-distributed kits may pose a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3002-2024·2024-09-18

    Medline Convenience Kits with Defective Plastic Syringes Recalled Globally

    Medline recalls convenience kits with defective plastic syringes due to leaks, breakage, and quality issues identified in an FDA Safety Alert. The defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3131-2024·2024-09-18

    Surgical Dissector Recalled for Brown Discoloration on Hinge Area

    Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors due to brown discoloration or substance on the hinge area. The recall affects 71 units distributed across seven US states.

    Product
    NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3074-2024·2024-09-18

    Syringes with Needles Recalled for Substantial Design Differences from FDA Approval

    Sol-Millennium Medical Inc. is recalling multiple syringe models found to differ substantially from their FDA-cleared designs. The recalled products include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN branded syringes distributed in the United States and internationally.

    Product
    Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3092-2024·2024-09-18

    Medline ReNewal Reprocessed LigaSure Blunt Tip Recalled for Packaging Seal Defect

    Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3048-2024·2024-09-18

    Medline C-Section Convenience Kits Recalled for Syringe Quality Issues

    Medline is recalling C-section convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes may leak or break, posing a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3020-2024·2024-09-18

    Medline Recalls Medical Convenience Kits with Defective Plastic Syringes

    Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality issues.

    Product
    Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2) M1S1109 TRADITIONAL PROCESS-LF, Pack Number 946279 ; 3) 20GX6" FEMORAL ART LINE KIT, Pack Number ART1165; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) 3" RADIAL ARTERIAL LINE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3000-2024·2024-09-18

    Medline Tonsil and Adenoid Surgical Kits Recalled for Syringe Defects

    Medline is recalling Tonsil & Adenoid surgical convenience kits containing defective plastic syringes. The kits may leak or break, posing risks to patient safety.

    Product
    Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3060-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Quality Issues

    Medline is recalling medical convenience kits that contain plastic syringes with potential leaks, breakage, and other quality issues that may pose risks to patient health.

    Product
    Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number CDS984080F
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3018-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Plastic Syringe Quality Issues

    Medline is recalling convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K ; 2) PEDIATRIC MAJOR BASIN PACK-LF , Pack Number DYNJ0154061C ; 3) EYE BASIN PACK-LF , Pack Number DYNJ0259872M ; 4) EYE BASIN PACK-LF , Pack Number DYNJ0259872MH; 5) BASIN DBL…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2995-2024·2024-09-18

    Medline cardiac and surgical procedure convenience kits recalled worldwide

    Medline Industries recalled cardiac and surgical procedure convenience kits distributed worldwide including pacemaker, angiography, and open heart surgery kits.

    Product
    Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3017-2024·2024-09-18

    Medline Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline Convenience kits (MUNCY PACK, DYNJ03097D) are recalled due to plastic syringe defects. Affected units may leak, break, or have quality issues that could pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3004-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Syringe Quality Issues

    Medline is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3036-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V; 2) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408VH; 3) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492A ; 4) 6" ACE BANDAGE PACK-LF, Pack Number DYNJ0864492AH; 5)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2993-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Leaks and Breakage

    Medline is recalling multiple medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects identified in an FDA Safety Alert. The affected kits are used in various medical procedures.

    Product
    Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3051-2024·2024-09-18

    Medline Convenience Kits Recalled Due to Plastic Syringe Quality Defects

    Medline Industries is recalling medical convenience kits containing plastic syringes with leaks and breakage issues. These defects may pose risks to patient safety during medical procedures.

    Product
    Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3030-2024·2024-09-18

    Medline Convenience Kits with Defective Plastic Syringes Recalled

    Medline Industries is recalling multiple medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BREAST BIOPSY TRAY-LF, Pack Number SPEC0058A; 4) BREAST BIOPSY TRAY, Pack Number DYNDH1142A; 5) BREAST BIOPSY TRAY, Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3031-2024·2024-09-18

    Medical convenience kits with plastic syringes recalled for leaks and breakage

    Medline is recalling medical convenience kits with plastic syringes that may leak or break. The FDA issued a safety alert due to quality defects that could harm patients.

    Product
    Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3071-2024·2024-09-18

    Anesthesia Turnover Kit with Non-Sterile Mastisol Component Recalled

    Medline Industries recalls Anesthesia Turnover Kit Pack Number DYNJAA0377 due to a non-sterile Mastisol component placed in the sterile kit without proper labeling. This poses an infection risk if users assume the component is sterile.

    Product
    ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3007-2024·2024-09-18

    Medline Medical Convenience Kits with Defective Plastic Syringes Recalled

    Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3059-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Plastic Syringe Defects

    Medline is recalling multiple convenience kits containing plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak or break, potentially posing a risk to patient health.

    Product
    Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3076-2024·2024-09-18

    Syringes with Luer Slip Tips Recalled for Unapproved Design Modifications

    Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models because they are substantially different from FDA-approved designs and include major modifications to their intended use without approval.

    Product
    Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3045-2024·2024-09-18

    Medline medical convenience kits recalled for defective plastic syringes

    Medline is recalling medical convenience kits with plastic syringes affected by quality defects including leaks and breakage. The defective syringes may pose risks to patient safety during medical procedures.

    Product
    Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6)…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3057-2024·2024-09-18

    Medline Convenience Kits with Defective Plastic Syringes Recalled

    Medline is recalling Convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality defects that may pose a risk to patient safety.

    Product
    Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3015-2024·2024-09-18

    Medline medical convenience kits with syringes recalled due to leakage and breakage

    Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects kits distributed worldwide.

    Product
    Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAINAGE TRAY, Pack Number DYNDA1063; 4) DRAINAGE ACCESS PACK 319701 , Pack Number DYNJ44599I ; 5) PROCEDURE DRAINAGE KIT, Pack…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3093-2024·2024-09-18

    Medline ReNewal Surgical Sealer/Divider Recalled for Incomplete Packaging Seal

    Medline Industries is recalling 2,860 units of its ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider due to potential incomplete seals on packaging trays, which could compromise sterility assurance.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3107-2024·2024-09-18

    Medline Surgical Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling 1,646 units of semi-rigid suction liners used in surgical kits due to reported adverse events involving potential loss of suction or low suction during intermittent use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3118-2024·2024-09-18

    Medline semi-rigid suction liners recalled for potential loss of suction

    Medline Industries recalls MTHZ GYN LAPAROSCOPY convenience kits with semi-rigid suction liners due to potential loss of suction during intermittent use. Affected products were manufactured between September and November 2023.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3109-2024·2024-09-18

    Medline Semi-Rigid Suction Liners Recalled for Potential Loss of Suction

    Medline Industries is recalling 407 units of semi-rigid suction liners manufactured between September and November 2023 due to potential loss of suction during intermittent use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MINOR, Pack Number DYNJ908099B; c) HEAD & NECK, Pack Number DYNJ908101B; d) NASAL FESS, Pack Number DYNJ908105B; e) NASAL-LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3072-2024·2024-09-18

    Sterile Anesthesia Kits Recalled for Non-Sterile Component Mixing

    Medline Industries recalled anesthesia kits containing an unlabeled non-sterile Mastisol component that could be mistakenly assumed sterile during use, creating infection risk. The recall affects 315 units distributed in Texas, Illinois, and California.

    Product
    ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3124-2024·2024-09-18

    Blood Pressure Module Fails to Record or Alarm in Hemodialysis Machines

    Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.

    Product
    Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3100-2024·2024-09-18

    Medical device diagnostic test shows measurement bias in certain samples

    Siemens Atellica IM CA 19-9 diagnostic tests show elevated measurement bias in certain sample ranges, particularly near the clinical threshold. Lot numbers 55974535 and 55975535 were distributed nationwide.

    Product
    Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3021-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Plastic Syringe Quality Issues

    Medline is recalling multiple convenience kits containing defective plastic syringes that may leak or break, posing potential patient health risks. The defective syringes were identified through an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2989-2024·2024-09-18

    Medline Spinal Block Syringes Recalled for Quality Defects

    Medline is recalling spinal block syringes due to leaks, breakage, and other quality issues identified in an FDA safety alert. The recalled lots have worldwide distribution and span from 2019 to 2023.

    Product
    Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3077-2024·2024-09-18

    SOL-M Syringes with eccentric tips recalled for regulatory non-compliance

    Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.

    Product
    Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2997-2024·2024-09-18

    Medline recalls medical convenience kits with defective plastic syringes

    Medline Industries recalls medical convenience kits containing plastic syringes with quality defects including leaks and breakage that may pose risks to patient health. No injuries have been reported.

    Product
    Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2999-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline is recalling medical convenience kits containing plastic syringes affected by quality issues including leaks and breakage. The defects may pose risks during dental and surgical procedures.

    Product
    Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURGERY PACK-LF, Pack Number DYNJ17477F ; 5) ORAL SURGERY PACK-LF, Pack…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3068-2024·2024-09-18

    FDA Recalls Transcend Dental Composite Material Due to Manufacturing Defect

    Ultradent Products is recalling Transcend Singles Universal Body dental composite resin due to red particulates found during manufacturing. The recall affects approximately 2,450 units distributed in the US and several foreign countries.

    Product
    Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for…
    Category
    Medical Device
    Distribution
    35 states

Looking for a different month? Back to 2024.