The Recall Desk

Archive

September 2024 recalls

704 recalls were announced in September 2024.

What the numbers show

Critical
8
Severe
100
High
396
Moderate
199
Low
1

Of the 704 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

501–600 of 704

  • HighFDA (Devices)·Z-2740-2024·2024-09-04

    Medline Baby Care Kits Recalled Due to Syringe Quality Issues

    Medline is recalling Baby Care Kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.

    Product
    Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025; 2) BABY CARE KIT UNIV, Pack Number DYKL1025H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2762-2024·2024-09-04

    Medline procedural kits recalled due to syringe quality issues

    Medline is recalling specific procedural kits because they contain plastic syringes with leaks or breakage risks that may pose a threat to patient health.

    Product
    Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584; 2) SR C SECTION, Pack Number DYNJ908584A; 3) C SECTION, Pack Number DYNJ909098
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2731-2024·2024-09-04

    Stryker iBur 3.0mm surgical burr recalled over thermal hazard

    Stryker Corporation is recalling the iBur 3.0mm Precision Match Head surgical burr because it may generate higher-than-specified temperatures during use, potentially causing thermal injury that may require medical intervention.

    Product
    Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2024·2024-09-04

    Medline Umbilical Line Kits Recalled Due to Syringe Quality Issues

    Medline is recalling Umbilical Line Kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.

    Product
    Medline procedural kits labeled as: UMBILICAL LINE KIT W/FOAM, Pack Number DYNDL1588A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2898-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 123 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001649;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2024·2024-09-04

    Immunoassay analyzer software may delay test processing with automation systems

    A software issue in DxI 9000 Access analyzers connected to laboratory automation systems may prevent processing of all samples, flagging tests as timed out and potentially delaying patient results.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2024·2024-09-04

    Medical procedure kits recalled due to defective plastic syringes

    Medline's Centurion procedure kits are being recalled due to plastic syringes with leaks and breakage. The defective syringes may pose a risk to patient health during medical procedures.

    Product
    Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1745-2024·2024-09-04

    Spice Class Brand Ground Cinnamon Recalled for Elevated Lead Levels

    Spice Class brand Ground Cinnamon (7oz and 11oz jars) is recalled due to elevated lead levels (2,040 ppb). The manufacturer is American Spice LLC.

    Product
    Spice Class brand Ground Cinnamon packed in 7oz and 11oz PET jars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1756-2024·2024-09-04

    NOW Real Foods Brazil Nuts Recalled for Mold and Yeast Contamination

    NOW Real Foods Whole & Unsalted Raw Brazil Nuts are recalled due to high levels of mold, yeast, and microbial contamination. The recall affects 7,854 units distributed nationwide and to Singapore.

    Product
    NOW Real Foods Whole & Unsalted Raw Brazil Nuts 12oz. bag UPC 733739070128
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1753-2024·2024-09-04

    Ground cinnamon recalled due to elevated lead levels

    Colonna Brothers Inc. is recalling Supreme Tradition and Marcum brand ground cinnamon distributed nationwide due to elevated lead levels.

    Product
    Ground cinnamon. Supreme Tradition brand ground cinnamon packaged in 2.25 oz clear plastics jars with black lids. UPC: 639277656377 Marcum brand ground cinnamon packaged in 1.5 oz clear plastic jars with black lids. UPC:051933364035
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1754-2024·2024-09-04

    Ground Cinnamon Products Recalled Due to Elevated Lead Levels

    Gutierrez Distributors recalls ground cinnamon products (El Servidor Corp and Canela Molida brands) due to elevated lead levels. Consumers who purchased these products should not use them.

    Product
    El Servidor Corp Ground Cinnamon Net Wt. 1.5 oz. UPC: 745245113244. Packaged in clear plastic bag. 12 bags per case. Gutierrez Distributor Canela Molida Ground Cinnamon 1.5 oz. UPC: 852705000164 Packaged in clear plastic bag.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0644-2024·2024-09-04

    Prescription Ibuprofen Recalled Due to Failed Impurity Specifications

    Dr. Reddy's Laboratories is recalling IBU (Ibuprofen) 800 mg prescription tablets nationwide due to failed quality specifications. Testing found unknown impurities exceeding acceptable limits.

    Product
    IBU — IBU (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0647-2024·2024-09-04

    Ibuprofen Tablets Recalled Due to Failed Impurities and Degradation Specifications

    Preferred Pharmaceuticals is recalling 266 bottles of generic ibuprofen tablets due to failed impurities and degradation specifications discovered during stability testing. The affected lots were distributed in California and Nevada.

    Product
    Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0646-2024·2024-09-04

    Prescription Ibuprofen Tablets Recalled for Excessive Unknown Impurities

    Dr. Reddy's Laboratories is recalling IBU Ibuprofen 400 mg prescription tablets due to impurity levels exceeding specifications. The recall affects 14,940 bottles distributed nationwide in the USA and Puerto Rico.

    Product
    IBU — IBU (IBUPROFEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2024·2024-09-04

    Stryker iBur surgical burs recalled due to overheating risk

    Stryker Corporation recalls iBur 3.0mm surgical burs used in neurosurgery, spinal, and ENT procedures due to potential overheating at the bur-shank interface. The heat risk may cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2634-2024·2024-09-04

    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) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2775-2024·2024-09-04

    Medical procedure packs containing defective syringes recalled by Medline

    Medline is recalling Centurion procedure packs with plastic syringes that have leaks, breakage, and other quality issues. These defects may pose a risk to patient health.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2624-2024·2024-09-04

    Medical Convenience Kits with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling over 1.6 million medical convenience kits containing plastic syringes that may leak or break, posing a potential risk to patient safety. The affected kits are distributed worldwide.

    Product
    see RES for description
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2631-2024·2024-09-04

    Medline procedure packs with syringes recalled due to leaks and breakage

    Medline Industries recalled procedure packs containing Shenli syringes due to leaks, breakage, and quality defects. The recalled units were distributed worldwide and may pose a risk to patient health.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2752-2024·2024-09-04

    Medline surgical procedure kits recalled due to defective plastic syringes

    Medline is recalling surgical procedure kits containing plastic syringes that may leak or break. The kits were distributed worldwide and may pose a risk to patient health.

    Product
    Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCIS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2798-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

    Beaver Visitec International voluntarily recalled BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The recall affects 69 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000162;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2024·2024-09-04

    Custom Orthopedic Surgical Implant Does Not Match Design Specifications

    A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.

    Product
    Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1751-2024·2024-09-04

    Infant Formula Recalled Due to Excess Vitamin D Levels

    CVS Health and HEB Baby Premium Infant Formula with Iron is recalled due to vitamin D levels exceeding permitted maximums. The recall affects 16,500 units.

    Product
    CVS Health brand and HEB Baby brand Premium Infant Formula with Iron Milk-Based Powder; packaged in 964g composite cans; 4 cans per case; UPC 50428318034 and 41220164578
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-2724-2024·2024-09-04

    Stryker iBur 2.0mm Diamond Round Burr Thermal Hazard Recall

    Stryker recalled 1,226 iBur surgical burrs with multiple lot numbers worldwide due to potential overheating at the bur-shank connection point, which could cause tissue damage requiring medical intervention.

    Product
    Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2024·2024-09-04

    Medline dialysis procedure packs recalled for syringe leaks and breakage

    Medline procedure packs containing Shenli syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall involves 1,679,067 units distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ91
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V651000·2024-09-04

    2021-2024 Volkswagen ID.4 Door Handles May Fail Due to Water Ingress

    Volkswagen is recalling 2021-2024 ID.4 vehicles because door handles may allow water to enter the circuit board, causing doors to open unexpectedly while driving. Owners should contact Volkswagen dealers for free inspection and repair.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2743-2024·2024-09-04

    Medline procedural kit syringes recalled for leaks and breakage

    Medline Industries is recalling multiple surgical procedural kits containing plastic syringes with quality defects. The syringes may leak or break during use, posing a risk to patient safety.

    Product
    Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2768-2024·2024-09-04

    Medline Centurion Procedure Kits Recalled for Syringe Leaks and Breakage

    Medline Industries is recalling multiple Centurion procedure kit models due to plastic syringe defects including leaks and breakage that may pose a risk to patient safety. The affected kits were distributed worldwide.

    Product
    Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number PICC0020; 3) 6" FEMORAL ARTERIAL LINE KIT, Pack Number ART245B; 4) ADVANCED REPAIR KIT, Pack Number SUT15940; 5) ARTHROGRAM TRAY, Pack Numbe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2614-2024·2024-09-04

    Pediatric Tracheostomy Tubes Recalled Due to Defective Securement Flange

    Smiths Medical recalls pediatric tracheostomy tubes from specific lots due to a manufacturing defect that may cause the securement flange to tear. No injuries have been reported.

    Product
    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRA
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2741-2024·2024-09-04

    Medline preop nerve block trays recalled for syringe quality defects

    Medline is recalling Preop Nerve Block Tray kits worldwide due to plastic syringes with leaks, breakage, and quality defects. These defects were identified in an FDA safety alert and may pose risks to patient health.

    Product
    Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DYNJRA2040H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2632-2024·2024-09-04

    Medline procedure packs with Shenli syringes recalled for leaks and breakage

    Medline is recalling medical procedure packs containing Shenli syringes due to identified leaks, breakage, and quality issues. These kits may pose a risk to patient health during surgical procedures.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2774-2024·2024-09-04

    Centurion medical syringes recalled for leaks and breakage

    Medline recalls Centurion procedure packs containing Caina syringes due to leaks, breakage, and quality issues that may pose risks to patient health in surgical procedures.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 2) RETINAL INJECTION KIT, Pack Number MNS12465
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2886-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M-manufactured syringes. The recall affects 138 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001579;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2024·2024-09-04

    Stryker iBur surgical bur recalled for potential overheating at junction

    Stryker has recalled 1171 units of iBur 5.0mm surgical burs due to potential overheating at the bur shank junction. The overheating could cause thermal injury requiring medical intervention.

    Product
    Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2024·2024-09-04

    Centurion Procedure Packs with Plastic Syringes Recalled for Leaks and Breakage

    Medline Industries is recalling Centurion procedure packs containing plastic syringes due to leaks, breakage, and quality defects that may pose a risk to patient health. The affected products are distributed worldwide.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Numbe
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2635-2024·2024-09-04

    Medline Medical Convenience Kits with Plastic Syringe Defects

    Medline is recalling approximately 1.68 million medical convenience kits with plastic syringes affected by leaks and breakage. The defects may pose a risk to patient health per an FDA Safety Alert issued March 19, 2024.

    Product
    Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NER
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2773-2024·2024-09-04

    Medical convenience kits with syringes recalled due to quality issues

    Medline Industries is recalling Centurion procedure packs containing plastic syringes affected by an FDA Safety Alert from March 19, 2024. The syringes may have leaks, breakage, or other quality issues that could pose a health risk.

    Product
    Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2830-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Defective Sol-M Syringes Recalled

    Beaver Visitec International recalls BVI CustomEyes Procedure Packs containing defective Sol-M syringes. About 1,756 units were distributed nationwide due to manufacturing defects.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000867;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2024·2024-09-04

    Centurion Procedure Packs with Defective Syringes Recalled Worldwide

    MEDLINE INDUSTRIES is recalling Centurion procedure packs containing syringes with documented leaks, breakage, and other quality defects. The affected syringes may pose a risk to patient health during medical procedures.

    Product
    Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISION TRAY, Pack Number CIT6860A; 5) CIRCUMCISION TRAY, Pack N
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2728-2024·2024-09-04

    Stryker iBur Surgical Bur Recall Due to Excessive Heat Risk

    Stryker is recalling iBur 4.0mm Coarse Diamond surgical burs that may overheat during use. Excessive heat could cause tissue or bone damage requiring medical intervention.

    Product
    Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2024·2024-09-04

    Stryker iBur Diamond Round surgical bur recalled for thermal overheating risk

    Stryker iBur 4.0mm Diamond Round surgical burs may reach temperatures higher than specified, potentially causing thermal injury or tissue damage during bone-cutting procedures. Approximately 1,706 affected units have been distributed worldwide.

    Product
    Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2725-2024·2024-09-04

    Stryker surgical bur may overheat and cause thermal tissue damage

    Stryker iBur surgical burs may overheat during use in neurosurgery and spine surgery, potentially causing thermal tissue damage requiring medical intervention. Approximately 2,507 units were distributed worldwide.

    Product
    Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2024·2024-09-04

    Medical Convenience Kits with Defective Plastic Syringes Recalled

    Medline Industries recalls medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose risks to patient health. About 1.6 million units were distributed worldwide.

    Product
    See RES Description
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2627-2024·2024-09-04

    Medline Procedure Packs With Syringes Recalled for Quality Defects

    Medline Industries has recalled over 1.6 million procedure packs containing syringes due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected packs were distributed worldwide.

    Product
    Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2760-2024·2024-09-04

    Medline procedural kits recalled for syringe leaks and breakage

    Medline procedural kits contain plastic syringes with leaks and breakage that may pose health risks. The affected kits are used for delivery procedures and distributed worldwide.

    Product
    Medline procedural kits labeled as: 1) INFANT DELIVERY KIT , Pack Number DYKM1426; 2) SR OB DELIVERY , Pack Number DYNJ908583; 3) SR OB DELIVERY , Pack Number DYNJ908583A; 4) VAG DELIVERY, Pack Number DYNJ909097
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2747-2024·2024-09-04

    Medline Procedural Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple procedural kits containing plastic syringes that may leak, break, or have quality defects. These defects may pose a risk to patient health during surgical procedures.

    Product
    Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2767-2024·2024-09-04

    Medical procedure kits with defective plastic syringes recalled due to quality issues

    Medline Industries is recalling Centurion procedure kits due to plastic syringes with defects including leaks and breakage. These defects may compromise patient safety during medical procedures.

    Product
    Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, Pack Number ART1170; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) ARTHROGRAPH TRAY, Pack Number MNS12670A; 5) BIOPSY SKIN/LACER
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2854-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Defective Syringes Recalled Nationwide

    BVI CustomEyes Procedure Packs containing Sol-M syringes are being voluntarily recalled due to a defect in the syringes.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001304;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2803-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringes

    Beaver Visitec International is recalling 214 BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000287;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2895-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue

    Beaver Visitec International is recalling 42 units of BVI CustomEyes Procedure Packs because they contain Sol-M syringes subject to a separate voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001634;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2836-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001014;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2828-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue

    Beaver Visitec International is recalling 59 BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000828;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2894-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Defect

    Beaver Visitec International is recalling 84 units of BVI CustomEyes Procedure Packs because they contain Sol-M syringes subject to a separate voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001631;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2903-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue

    Beaver Visitec International is recalling 44 units of BVI CustomEyes Procedure Packs because they contain syringes from Sol-Millennium Medical, which are subject to a separate voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001699;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2858-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Defect

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001315;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2873-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001478;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2812-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Defect

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes due to a voluntary recall of the syringe components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000508;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2918-2024·2024-09-04

    CustomEyes Procedure Packs with Sol-M Syringes Recalled by Beaver Visitec International

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs (Lot 6066752) containing Sol-M syringes. Approximately 22 units distributed nationwide in the US have been affected.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001836;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2783-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M low dead space and luer slip tip syringes (Part Number 584545) nationwide. The recall is voluntary.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584545;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2930-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    BVI CustomEyes Procedure Packs are being recalled because they contain Sol-M manufactured syringes that are subject to a voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001970;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2800-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntarily Recalled

    BVI CustomEyes Procedure Packs containing syringes made by Sol-Millennium Medical (Sol-M) are being voluntarily recalled. These affected syringes are low dead space and luer slip tip 1ml models.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000192;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1752-2024·2024-09-04

    J-Basket Napa Kimchi Recalled for Yeast Growth and Surface Film

    J F C International Inc is recalling J-Basket Napa Kimchi jars due to high levels of yeast growth and film formation. About 2,735 cases distributed to ten U.S. states have best before dates of October 26 or December 19, 2024.

    Product
    J-Basket Brand, Napa Kimchi, Net Wt. 14.1oz. plastic jar container (12 jars per case).
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0648-2024·2024-09-04

    Cefixime oral suspension antibiotic recalled nationwide for subpotency

    Lupin Pharmaceuticals is recalling Cefixime 100 mg/5 mL oral suspension due to subpotency discovered during stability testing. The affected lot (F201517) was distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2914-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain Sol-M low dead space and luer slip syringes. The recall affects 150 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001795;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2869-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical, Inc. Approximately 70 units have been distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001411;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2907-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Voluntarily Recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. No illnesses or injuries have been reported.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001713;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2784-2024·2024-09-04

    FDA recalls BVI CustomEyes ophthalmic procedure packs nationwide

    Beaver Visitec International initiated a voluntary recall of BVI CustomEyes Procedure Packs containing surgical syringes (Part Number 584550, Lot 6048601) distributed nationwide. The Class II recall was initiated on July 26, 2024.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584550;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2820-2024·2024-09-04

    Syringes in BVI CustomEyes Procedure Packs subject to voluntary recall

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical. The FDA has classified this as a Class II medical device recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000749;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2938-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled for Sol-M syringe components

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes with low dead space and luer slip tip configurations. The product was distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2799-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Supplier Syringe Recall

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain Sol-M syringes following the manufacturer's voluntary recall of these components.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000168;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2024·2024-09-04

    FDA recalls BVI CustomEyes Procedure Packs with Sol-M syringes

    The FDA is issuing a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes affecting 1,029 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001622;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2808-2024·2024-09-04

    BVI Recalls CustomEyes Procedure Packs Containing Recalled Sol-M Syringes

    BVI is recalling CustomEyes Procedure Packs because they contain syringes subject to a separate voluntary recall by manufacturer Sol-Millennium Medical. The recall affects 217 units nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000455;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2924-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled due to defective syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes due to a voluntary manufacturer recall. The affected packs were distributed nationwide in the U.S.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001928;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling 4,301 units of BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001658;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2896-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Recalled Sol-M Syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical, Inc., subject to a voluntary recall by the manufacturer.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2785-2024·2024-09-04

    BVI Voluntarily Recalls CustomEyes Procedure Packs Containing Sol-M Syringes

    BVI is voluntarily recalling CustomEyes Procedure Packs that contain Sol-M manufactured syringes. The affected products were distributed nationwide in the United States.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584587;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2909-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The recall affects 98 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2910-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing 1ml syringes manufactured by Sol-Millennium Medical, Inc., distributed nationwide in the United States.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001753;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2811-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled for syringe manufacturing defect

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected procedure packs contain low dead space Luer Lock and Luer Slip 1ml syringes distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000501;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2790-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled Voluntarily

    BVI CustomEyes Procedure Packs containing low dead space and luer slip syringes from Sol-Millennium Medical are being voluntarily recalled.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584727;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2796-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Syringe Manufacturer Issue

    Beaver Visitec International voluntarily recalls specific CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. No injuries or illnesses have been reported.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000120;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2936-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical. The voluntary recall affects 104 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002074;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2885-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled due to Sol-M syringes

    BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled due to a voluntary manufacturer recall of the syringe components included in these procedure packs.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2868-2024·2024-09-04

    BVI CustomEyes Procedure Packs With Recalled Sol-M Syringes

    BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical are being voluntarily recalled. The affected products are distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001395;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2822-2024·2024-09-04

    BVI CustomEyes Procedure Pack Syringes Voluntarily Recalled Nationwide

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M Inc. due to a voluntary manufacturer recall of certain syringe types distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000759;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2882-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall by the manufacturer. The procedure packs were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001545;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2781-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Defective Sol-M Syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes manufactured by Sol-Millennium Medical, Inc. due to a manufacturer's voluntary recall. 659 units are affected nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2900-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is recalling 627 units of BVI CustomEyes Procedure Packs due to included Sol-M syringes subject to voluntary manufacturer recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001691;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2905-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M syringes recalled

    Beaver Visitec International is voluntarily recalling 82 units of CustomEyes Procedure Packs containing Sol-M syringes due to a manufacturer recall. Affected lot numbers 6070885 and 6074819.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001711;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2890-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs with Sol-M Syringes

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, Inc. The affected packs were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2827-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Syringe Defect

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes. The voluntary recall affects 237 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000813;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2913-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringes

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs that contain low dead space and luer slip tip syringes manufactured by Sol-Millennium Medical, Inc.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001775;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2908-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-M syringes (129 units distributed nationwide). The recall was initiated voluntarily due to an issue with the syringes.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001721;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2835-2024·2024-09-04

    FDA Recalls BVI CustomEyes Procedure Packs Containing Sol-M Syringes

    Beaver Visitec International has voluntarily recalled BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected procedure packs were distributed nationwide in the United States.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000985;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2837-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled for containing Sol-M syringes

    Beaver Visitec International is recalling 1,955 units of BVI CustomEyes Procedure Packs nationwide because they contain Sol-M syringes subject to a voluntary recall by the manufacturer.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001019;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2849-2024·2024-09-04

    Beaver Visitec recalls CustomEyes Procedure Packs with Sol-M syringes

    Beaver Visitec International is recalling 505 CustomEyes Procedure Packs containing Sol-Millennium Medical syringes that are subject to a voluntary manufacturer recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001174;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2931-2024·2024-09-04

    BVI CustomEyes Procedure Packs containing Sol-M syringes recalled

    Beaver Visitec International recalls CustomEyes Procedure Packs because they contain Sol-Millennium Medical syringes subject to a voluntary recall. Fourteen units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2920-2024·2024-09-04

    FDA Recalls BVI CustomEyes Procedure Packs with Sol-M Syringes

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary manufacturer recall. The affected packs have been distributed nationwide in the US.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001845;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2851-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical due to a supplier voluntary recall affecting 71 units nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001177;
    Category
    Medical Device
    Distribution
    Distributed nationwide

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