The Recall Desk

Archive

November 2025 recalls

538 recalls were announced in November 2025.

What the numbers show

Critical
62
Severe
48
High
306
Moderate
118
Low
4

Of the 538 recalls this month scored against our rubric, 12% are Critical, 9% are Severe.

Which agencies issued them

401–500 of 538

  • HighFDA (Devices)·Z-0306-2026·2025-11-05

    Surgical console accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling six accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Descr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2026·2025-11-05

    Magseed Pro 12 cm markers recalled over potential cotton fiber contamination

    Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.

    Product
    Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2026·2025-11-05

    Graduated connectors recalled because port weld may separate and leak

    ICU Medical is recalling 1,700 Graduated Connectors with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0118-2026·2025-11-05

    Semaglutide 2.5 mg vials recalled for lack of sterility assurance

    ProRx is recalling 2,649 vials of Semaglutide Injection 2.5 mg/1 mL from one lot for lack of assurance of sterility.

    Product
    Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0108-2026·2025-11-05

    Desipramine 25 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 8,754 bottles of Desipramine Hydrochloride Tablets USP 25 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2026·2025-11-05

    Trocar sealing units with reducer recalled over detaching silicone fragments

    Aesculap is recalling 26 sealing units for 10/12mm trocars with reducer because silicone fragments may detach from the yellow sealing component.

    Product
    Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2026·2025-11-05

    21 inch extension sets recalled over port weld separation risk

    ICU Medical is recalling 950 21-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2026·2025-11-05

    Intraoperative ultrasound systems recalled over soldering that can shut them down

    Medistim is recalling 14 MiraQ ultrasound systems because insufficient soldering in the Printer Support Module may loosen wires and cause the system to shut down.

    Product
    Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0353-2026·2025-11-05

    Bag spikes with additive port recalled over port weld separation risk

    ICU Medical is recalling 6,450 6.5-inch bag spikes with ChemoLock additive port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2026·2025-11-05

    Testosterone 50 mg pellets recalled over potential presence of metal particulate

    FarmaKeio Outsourcing is recalling 829 sterile Testosterone 50 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2026·2025-11-05

    Bag spikes with Clave additive port recalled over port weld separation

    ICU Medical is recalling 3,000 ChemoLock Bag Spikes with Clave additive port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2026·2025-11-05

    Chandelier illuminators recalled over incomplete seals in the sterile pouch

    Alcon Research is recalling 330 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Softwa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0106-2026·2025-11-05

    Prazosin 5 mg capsules recalled over nitrosamine impurity above intake limit

    Teva Pharmaceuticals USA is recalling 107,673 units of Prazosin Hydrochloride Capsules 5 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2026·2025-11-05

    Smallbore extension sets recalled because port weld may separate and leak

    ICU Medical is recalling 200 60-inch smallbore extension sets with a ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2026·2025-11-05

    Non-sterile bulk ChemoLock ports recalled over port weld separation risk

    ICU Medical is recalling 2,000 bulk non-sterile ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2026·2025-11-05

    Trocar sealing caps recalled over silicone fragments detaching from sealing component

    Aesculap is recalling 140 sealing caps for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.

    Product
    Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2026·2025-11-05

    Capillary blood tubes recalled for causing false positive lead test results

    ASP Global is recalling 4,272,858 SAFE-T-FILL capillary blood collection tubes because tubes made between July 2023 and February 2025 cause false positive results on LeadCare testing systems.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2026·2025-11-05

    ChemoLock closed vial spikes recalled over port weld separation risk

    ICU Medical is recalling 6,150 ChemoLock Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Closed Vial Spike REF: CL-80
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2026·2025-11-05

    Augmented reality spine platform recalled over image layer misalignment in fusion

    Surgical Theater is recalling three units of its SpineAR SyncAR SNAP orthopedic augmented reality platform because a software anomaly may misalign secondary image layers.

    Product
    SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2026·2025-11-05

    73 inch smallbore extension sets recalled over port weld separation risk

    ICU Medical is recalling 200 73-inch smallbore extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0145-2026·2025-11-05

    Roasted and salted mixed nuts recalled over undeclared hazelnuts in allergen statement

    Severn Peanut Company is recalling 516 cases of 8 oz Roasted & Salted Mixed Nuts after finding hazelnuts were not listed in the allergen statement.

    Product
    MIXED NUTS Roasted & Salted NET WT 8 OZ (227g) INGREDIENTS: ALMONDS, WALNUTS, PEANUTS***CASHEWS***HAZELNUTS, BRAZIL NUTS CONTAINS: ALMONDS, BRAZIL NUTS, CASHEWS, PEANUTS, WALNUTS UPC 8 10111 02236 1 DIST BY: HAMPTON FARMS 180 AVOCADO ST. SPRINGFIELD, MA 01104
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·H-0144-2026·2025-11-05

    Pulled pork sandwiches recalled over potential plastic foreign material

    E.A. Sween Co. is recalling 32,732 cases, 327,320 individual units, of Deli Express BBQ Pulled Pork on a sesame bun over potential plastic foreign material.

    Product
    Deli Express BBQ Pulled Pork on a sesame bun. Net Wt 5.5oz (156g) UPC 0 41433-03087 5. EA Sween Company, Eden Prairie, MN 55344.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2026·2025-11-05

    ChemoLock vial spikes recalled because port weld may separate and leak

    ICU Medical is recalling 53,050 ChemoLock 20mm Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0139-2026·2025-11-05

    Cheddar caramel popcorn recalled over peanuts missing from the ingredient statement

    Jody's Inc. is recalling 8,244 units of Cabot Creamery Sea Salt Caramel Cheddar popcorn after two complaints that the product contains peanuts not listed in the ingredient statement.

    Product
    CaBOT CREAMERY SEA SALT CARAMEL CHEDDAR SWEET & CHEESY POPCORN 6.0oz bag CONTAINS: SOY & MILK UPC 8 50016 94430 6 MANUFACTURED FOR: VERMONT CHEESE PRODUCTS, INC 60 LAKE STREET, SUITE 2A BURLINGTON, VT 05401
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0115-2026·2025-11-05

    Semaglutide 10 mg vials recalled for lack of sterility assurance

    ProRx is recalling 8,400 vials of Semaglutide Injection 10 mg/4 mL for lack of assurance of sterility.

    Product
    Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0131-2026·2025-11-05

    Combination hormone pellets recalled over potential presence of metal particulate matter

    FarmaKeio Outsourcing is recalling 36,924 sterile Testosterone / Triamcinolone Acetonide 25MG/5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2026·2025-11-05

    Prazosin capsules recalled over nitrosamine impurity above the acceptable intake limit

    Teva Pharmaceuticals USA is recalling 291,512 bottles of Prazosin Hydrochloride Capsules 2 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0117-2026·2025-11-05

    Semaglutide 8 mg vials recalled for lack of sterility assurance

    ProRx is recalling 11,119 vials of Semaglutide Injection 8 mg/3.2 mL across four lots for lack of assurance of sterility.

    Product
    Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0099-2026·2025-11-05

    Adalimumab prefilled syringes recalled for lack of sterility assurance

    Samsung Bioepis is recalling 5,518 cartons, 11,036 prefilled syringes, of HADLIMA (adalimumab-bwwd) injection 40mg/0.8 mL from one lot for lack of assurance of sterility.

    Product
    HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0136-2026·2025-11-05

    Testosterone and triamcinolone 100 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 103,444 sterile Testosterone / Triamcinolone Acetonide 100MG/20MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0130-2026·2025-11-05

    Testosterone and triamcinolone 12.5 mg pellets recalled over metal particulate

    FarmaKeio Outsourcing is recalling 18,124 sterile Testosterone / Triamcinolone Acetonide 12.5MG/2.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2026·2025-11-05

    Testosterone and triamcinolone 37.5 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 43,424 sterile Testosterone / Triamcinolone Acetonide 37.5MG/7.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0128-2026·2025-11-05

    Testosterone 50 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 4,829 sterile Testosterone Regular Release 50 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0111-2026·2025-11-05

    Desipramine 100 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 5,882 bottles of Desipramine Hydrochloride Tablets USP 100 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0326-2026·2025-11-05

    Daily contact lenses recalled over a weak seal compromising sterility

    Alcon Research is recalling 82 units of PRECISION1 One-Day Contact Lenses in -2.25D because some units may have a weak seal that compromises sterility.

    Product
    Alcon PRECISION1 One-Day Contact Lenses, -2.25D.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0348-2026·2025-11-05

    Closed vial spikes with skirt recalled over port weld separation risk

    ICU Medical is recalling 8,475 ChemoLock Closed Vial Spikes with Skirt because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2026·2025-11-05

    ChemoLock ports with Spiros recalled over port weld separation risk

    ICU Medical is recalling 2,000 ChemoLock Ports with Spiros and red cap because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2026·2025-11-05

    Syringe transfer sets recalled because port weld may separate and leak

    ICU Medical is recalling 900 Syringe Transfer Sets with MicroClave and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2026·2025-11-05

    Vented vial spikes recalled because port weld may break during use

    ICU Medical is recalling 80 units of ChemoLock Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2026·2025-11-05

    Universal vented vial spikes recalled because port weld may separate and leak

    ICU Medical is recalling 2,100 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2026·2025-11-05

    BrainSTORM surgical planner recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling three units of its BrainSTORM Surgical Planner because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2026·2025-11-05

    CT 5300 scanners recalled over six software faults affecting movement and dose

    Philips Medical Systems is recalling 165 CT 5300 scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0412-2026·2025-11-05

    Sample preparation systems recalled over incorrect dead volumes in instructions

    Beckman Coulter is recalling 108 CellMek SPS sample preparation systems because the instructions for use list incorrect dead volumes and the software does not rock Cassette E.

    Product
    CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0413-2026·2025-11-05

    Blood glucose meters recalled over display segments that can misread values

    Trividia Health is recalling 601 Good Neighbor Pharmacy TRUE METRIX blood glucose meters over a display defect that can cause glucose values to be misread.

    Product
    Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0362-2026·2025-11-05

    Oncology kits recalled because a port weld may separate and leak

    ICU Medical is recalling 200 Oncology Kits with two ChemoLock components because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2026·2025-11-05

    Endoscopic navigation platform recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 19 units of its EndoSNAP platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2026·2025-11-05

    Desipramine 75 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 2,418 bottles of Desipramine Hydrochloride Tablets USP 75 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2026·2025-11-05

    ChemosafeLock connectors recalled because port weld may break and leak

    ICU Medical is recalling 134,700 ChemosafeLock Connectors because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Connecter REF: KL-FNU3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2026·2025-11-05

    Infusion line packs recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 25,778 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2026·2025-11-05

    Clave bag spikes recalled because port weld may separate and leak

    ICU Medical is recalling 200 Clave Bag Spikes with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0328-2026·2025-11-05

    Single unit bag spikes recalled over port weld separation risk

    ICU Medical is recalling 875 single-unit ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ChemoLock Bag Spike, 01 units REF: CL-10-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2026·2025-11-05

    Medication dispensing stations recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 2,755 BD Pyxis MedFlex units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0107-2026·2025-11-05

    Desipramine tablets recalled over nitrosamine impurity above acceptable daily intake

    Heritage Pharmaceuticals is recalling 6,979 bottles of Desipramine Hydrochloride Tablets USP 10 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0114-2026·2025-11-05

    Compounded semaglutide vials recalled for lack of sterility assurance

    ProRx is recalling 2,809 vials of Semaglutide Injection 12.5 mg/5 mL from one lot for lack of assurance of sterility.

    Product
    Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0358-2026·2025-11-05

    Chemotherapy extension sets recalled because port weld may separate during use

    ICU Medical is recalling 2,450 8-inch extension sets with ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2026·2025-11-05

    Reducing converters recalled over silicone fragments detaching from sealing component

    Aesculap is recalling 155 reducing converters because silicone fragments may detach from the yellow sealing component.

    Product
    Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0120-2026·2025-11-05

    Compounded tirzepatide vials recalled for lack of sterility assurance

    ProRx is recalling 2,761 vials of Tirzepatide Injection 27 mg/3 mL from one lot for lack of assurance of sterility.

    Product
    Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0349-2026·2025-11-05

    13mm closed vial spikes recalled because port weld may separate and leak

    ICU Medical is recalling 3,350 ChemoLock 13mm Closed Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0126-2026·2025-11-05

    Testosterone 87.5 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 529 sterile Testosterone 87.5 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2026·2025-11-05

    Pyxis Pro MedStation units recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 27 BD Pyxis Pro MedStation Main units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    BD Pyxis Pro MedStation Main, REF: 1155-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2026·2025-11-05

    Chemotherapy vial adapters recalled because port weld may separate and leak

    ICU Medical is recalling 202,900 ChemosafeLock Vial Adapters because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2026·2025-11-05

    Surgical imaging software recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0119-2026·2025-11-05

    Semaglutide 5 mg vials recalled for lack of sterility assurance

    ProRx is recalling 2,805 vials of Semaglutide Injection 5 mg/2 mL from one lot for lack of assurance of sterility.

    Product
    Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0123-2026·2025-11-05

    Testosterone pellets recalled over potential presence of metal particulate matter

    FarmaKeio Outsourcing is recalling 1,329 sterile Testosterone 25 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2026·2025-11-05

    Nasal test kits recalled after a false negative on a positive sample

    Cepheid is recalling 4,132 Xpert SA Nasal Complete kits after post-market half-time stability testing produced a false negative result for a positive sample type.

    Product
    Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0311-2026·2025-11-05

    Trocar sealing units recalled over silicone fragments detaching from sealing component

    Aesculap is recalling 26 sealing units for 10/12mm trocars because silicone fragments may detach from the yellow sealing component.

    Product
    Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2026·2025-11-05

    ChemoLock ports recalled because the port weld may separate and leak

    ICU Medical is recalling 133,255 ChemoLock Ports because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Port REF: CL2100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2026·2025-11-05

    CT scanners recalled over six software faults affecting movement and dose

    Philips Medical Systems is recalling 105 Incisive CT scanners on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Drugs)·D-0134-2026·2025-11-05

    Testosterone and triamcinolone pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 31,124 sterile Testosterone / Triamcinolone Acetonide 62.5MG/12.5MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0116-2026·2025-11-05

    Semaglutide 6 mg vials recalled for lack of sterility assurance

    ProRx is recalling 8,310 vials of Semaglutide Injection 6 mg/2.4 mL across three lots for lack of assurance of sterility.

    Product
    Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0129-2026·2025-11-05

    Testosterone 200 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 14,329 sterile Testosterone Regular Release 200 mg pellets over the potential presence of metal particulate matter.

    Product
    Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2026·2025-11-05

    Chemotherapy administration sets recalled because port weld may separate and leak

    ICU Medical is recalling 7,950 20-drop administration sets with an integrated ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2026·2025-11-05

    Oncology kits with vented vial spike recalled over port weld failure

    ICU Medical is recalling 1,100 Oncology Kits containing a ChemoLock Universal Vented Vial Spike because the port weld of the drug transfer device may separate or break and leak.

    Product
    ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2026·2025-11-05

    Brazil market CT scanner recalled over six software faults affecting movement

    Philips Medical Systems is recalling one Incisive CT for Brazil SKD unit on software versions 5.1.0.X and 5.1.1.X over six software issues, including unintentional gantry and couch movement.

    Product
    Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Drugs)·D-0133-2026·2025-11-05

    Testosterone and triamcinolone 50 mg pellets recalled over metal particulate matter

    FarmaKeio Outsourcing is recalling 64,924 sterile Testosterone / Triamcinolone Acetonide 50MG/10MCG pellets over the potential presence of metal particulate matter.

    Product
    Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2026·2025-11-05

    Testosterone 62.5 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 829 sterile Testosterone 62.5 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2026·2025-11-05

    Pyxis Medbank units recalled over fluid ingress causing smoke or fire

    CareFusion is recalling 8,262 BD Pyxis Medbank units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

    Product
    Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 138911-01 138912-01 138913-01 138914-01 138915-01 138916-01 138917-01 138918-01 13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2026·2025-11-05

    Entry system accessories recalled over incomplete seals in sterile pouches

    Alcon Research is recalling 1,632 accessory devices for Unity and Constellation surgical consoles because of incomplete seals in the pouch that provides the sterile barrier.

    Product
    Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0112-2026·2025-11-05

    Desipramine 150 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 3,750 bottles of Desipramine Hydrochloride Tablets USP 150 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2026·2025-11-05

    Unit dose prazosin 5 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2026·2025-11-05

    Infusion pumps recalled over phantom touches on the touchscreen corner

    Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0319-2026·2025-11-05

    Surgical planning software recalled over image layer misalignment in 2D fusion

    Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.

    Product
    SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2026·2025-11-05

    Initiation coated and nude super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0141-2026·2025-11-05

    Everolimus 10 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 935 cartons of Everolimus tablets 10 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2026·2025-11-05

    Initiation 36 coated super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 36 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0385-2026·2025-11-05

    Coated and nude super tampon packs recalled over missing 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Super and 9 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0140-2026·2025-11-05

    Everolimus 7.5 mg tablets recalled after an out of specification impurity result

    Endo USA is recalling 1,866 cartons of Everolimus tablets 7.5 mg after results came back out of specification for impurity IP-C.

    Product
    Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2026·2025-11-05

    Coated and nude regular tampons recalled because product lacks 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular and 9 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0145-2026·2025-11-05

    Lisdexamfetamine 20 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 20 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0411-2026·2025-11-05

    Ophthalmic knife suction sets recalled over residue on internal springs

    MicroSurgical Technology is recalling eight MST ArcDUO 9mm ophthalmic knives because springs in the accompanying suction set carry an unidentified residue that may cause eye irritation.

    Product
    MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0144-2026·2025-11-05

    Lisdexamfetamine 10 mg capsules recalled after failing dissolution at twelve month stability

    Sun Pharmaceutical Industries is recalling two lots of Lisdexamfetamine Dimesylate Capsules 10 mg after an out-of-specification dissolution result at the 12-month stability station.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2026·2025-11-05

    Coated and nude regular tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular Tampons and 9 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0122-2026·2025-11-05

    Sting relief swabs recalled from one lot over a product mix-up

    Acme United Corporation is recalling 2,338 boxes of First Aid Only Sting Relief Swabs from one lot over a product mix-up.

    Product
    Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0408-2026·2025-11-05

    Coagulation blood tubes recalled over a misplaced label shifting the fill mark

    Greiner Bio-One is recalling 504,000 VACUETTE 2 ml coagulation tubes because the label was applied too high, shifting the printed fill level mark upward.

    Product
    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2026·2025-11-05

    Refill three month all in one bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month All in One Bundle because the product lacks 510(k) clearance.

    Product
    Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
    Category
    Medical Device
    Distribution
    Distributed nationwide

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