The Recall Desk

Archive

September 2025 recalls

525 recalls were announced in September 2025.

What the numbers show

Critical
68
Severe
54
High
234
Moderate
98
Low
71

Of the 525 recalls this month scored against our rubric, 13% are Critical, 10% are Severe.

Which agencies issued them

401–500 of 525

  • HighFDA (Devices)·Z-2466-2025·2025-09-03

    Cystoscopy and TUR packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems cysto and TUR basin packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,127 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0605-2025·2025-09-03

    Alcohol prep pads recalled for isopropyl alcohol below labeled concentration

    Rite Aid Pharmacy first aid alcohol prep pads are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 984,000 pads.

    Product
    ALCOHOL — ALCOHOL (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2464-2025·2025-09-03

    Heart and vascular packs recalled because sterilization rationale was not justified

    American Contract Systems heart, vascular and off-pump CABG packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 31,506 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, M
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2472-2025·2025-09-03

    Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2465-2025·2025-09-03

    Lap chole and laparoscopy packs recalled over unmet sterilization assurance requirements

    American Contract Systems lap chole and laparoscopy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,233 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0604-2025·2025-09-03

    Good Neighbor alcohol prep pads recalled for alcohol below labeled concentration

    Good Neighbor Pharmacy Alcohol Prep Pads, distributed by AmerisourceBergen, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. 66,000 pads are affected.

    Product
    GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER — GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25V570000·2025-09-03

    Ducati Motorcycles Recalled for Defective Rear Wheel Axle

    Ducati is recalling certain 2018-2025 motorcycles because the rear wheel axle may lose structural integrity and break during riding, risking loss of control. Dealers will replace the axle free of charge.

    Product
    DUCATI — DUCATI STREETFIGHTER, STREETFIGHTER V2, PANIGALE V4 S, STREETFIGHTER V4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0598-2025·2025-09-03

    Sucralfate tablets recalled after bankruptcy left quality program unmonitored

    Sucralfate Tablets USP 1 gram from American Health Packaging are recalled because the firm's Chapter 11 filing left it unable to monitor its quality program. 26,992 blister packs are affected.

    Product
    Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0599-2025·2025-09-03

    Lisdexamfetamine 40 mg bottles recalled after being filled with 30 mg capsules

    Lisdexamfetamine Dimesylate Capsules 40 mg, lot 25280726A, distributed by Lannett, are recalled because a bottle labeled 40 mg contained 30 mg capsules. 8,544 bottles are affected.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0603-2025·2025-09-03

    H-E-B alcohol pads recalled for isopropyl alcohol below labeled concentration

    H-E-B inControl Sterile Alcohol Pads, 100 per container, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 300,000 pads.

    Product
    INCONTROL ALCOHOL — INCONTROL ALCOHOL (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0600-2025·2025-09-03

    Medline alcohol prep pads recalled for alcohol below labeled concentration

    Medline Alcohol Prep Pads, 70% isopropyl alcohol, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 6,669,874 swabs.

    Product
    MEDLINE ALCOHOL PREP — MEDLINE ALCOHOL PREP (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2025·2025-09-03

    Custom loupes with Dragonfly frames recalled over nickel nose pad allergy risk

    Orascoptic custom loupes with Dragonfly frames are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 15,245 units are affected.

    Product
    Orascoptic Superior Visualization Custom loupes with Dragonfly frames
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0601-2025·2025-09-03

    CURAD alcohol prep pads recalled for isopropyl alcohol below labeled strength

    CURAD Sterile Alcohol Prep Pads, medium 2-ply, are recalled nationwide because isopropyl alcohol levels fall below the labeled concentration. The recall covers 1,639,996 pads.

    Product
    CURAD ALCOHOL PREP PADS — CURAD ALCOHOL PREP PADS (ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2025·2025-09-03

    Hysterectomy procedure packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems robotic and vaginal hysterectomy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 50 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2445-2025·2025-09-03

    Phantom nose pad kits recalled because nickel content may cause allergic reaction

    Orascoptic Phantom Nose Pad Accessory Kits are recalled because loupe nose pads containing nickel may cause an allergic reaction, following complaints. 22 kits are affected.

    Product
    Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2342-2025·2025-09-03

    C-arm imaging systems recalled over missing lead tape in collimator covers

    GE HealthCare OEC 9800 and OEC 9900 Elite C-arm systems are recalled because impacted units are missing the full layer of lead tape in the collimator covers, slightly increasing radiation exposure.

    Product
    GE HealthCare OEC 9900 Elite C-arm Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2025·2025-09-03

    Surgical kits recalled because Foley tray inserts carry incorrect product information

    Medline kits containing BD SureStep Foley Tray Systems are recalled because the trays include incorrect product information insert sheets. Four units were distributed, all from the LAVH MINOR SKU.

    Product
    Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2467-2025·2025-09-03

    Perfusion and laparoscopy packs recalled over unjustified sterilization of certain components

    American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2462-2025·2025-09-03

    Foley catheters recalled because obstructed lumen may prevent bladder drainage

    Bardex Lubri-Sil I.C. Foley catheters and related tray systems are recalled because the catheter may have an obstructed lumen, which may prevent the bladder from draining. 175,158 units are affected.

    Product
    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0534-2025·2025-09-03

    Everything bagel mix recalled because label omits sesame and other ingredients

    Baker's Authority Everything Bagel Mix in 1 lb and 5 lb bags is recalled because the label does not list its ingredients, including the major food allergen sesame. 197 units are affected.

    Product
    Baker's Authority Everything Bagel Mix; 5lb bag and 1lb bag; stored dry at room temperature; packaged in silver bag
    Category
    Food
    Distribution
    17 states
  • HighFDA (Food)·H-0537-2025·2025-09-03

    Friendly's ice cream recalled over undeclared wheat and soy from mismatched cartons

    Friendly's 48 fl oz cartons labeled Vanilla Bean carry a Cookies and Cream lid and contain Cookies and Cream, leaving wheat and soy undeclared. 54 cases are affected.

    Product
    Carton Label: "Friendly's Vanilla Bean"; 48 fl. oz. Lid Label: "Friendly's Cookies and Cream" Product in carton is Cookies and Cream.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·H-0549-2025·2025-09-03

    Raw frozen shrimp recalled over possible contamination with cesium-137

    Great Value and Sea Best branded raw frozen shrimp in bulk master cartons, product of Indonesia, is recalled because the product may be contaminated with Cesium-137. 33,164 pounds are affected.

    Product
    Great Value branded and Sea Best branded raw frozen shrimp in bulk packaging, master cartons. Master carton case is 20 lbs (10 x 2lbs retail bags), and 18 lbs (12 x 1.5lbs retail bags) and (10x1lb retail bags), Product of Indonesia, Keep Frozen, Distributed by Beaver Street Fish
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2468-2025·2025-09-03

    Craniotomy and shunt packs recalled over unjustified sterilization of certain components

    American Contract Systems craniotomy and shunt procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 204 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·H-0577-2025·2025-09-03

    Hostess Ding Dongs recalled over mold traced to malfunctioning cooler

    Hostess Ding Dongs in twin packs and 10- and 16-count cartons are recalled for mold, which the firm traced to a malfunctioning cooler after customer complaints rose. 60,630 cases are affected.

    Product
    Hostess Ding Dongs CHOCOLATE CAKE WITH CREAMY FILLING 2.55 oz twin pack UPC 8 88109 01002 7; 10-1.28 oz carton (12.7 oz) UPC 8 88109 11061 1; 16-1.28 oz carton (20.31 oz) Individual selling unit - UPC 8 88109 01182 6 16-count selling unit - UPC 8 88109 11092 5
    Category
    Food
    Distribution
    42 states
  • HighFDA (Food)·H-0533-2025·2025-09-03

    Three seed baking mix recalled because label omits sesame and other ingredients

    Baker's Authority Three Seed Mix in 5 lb bags is recalled because the label does not list ingredients, including the major food allergen sesame. Millet and flax are also undeclared. 78 units are affected.

    Product
    Baker's Authority Three Seed Mix; 5lb bag; stored dry at room temperature; packaged in silver bag
    Category
    Food
    Distribution
    17 states
  • HighFDA (Food)·H-0548-2025·2025-09-03

    Bulk frozen shrimp recalled over insanitary conditions and possible cesium-137 contamination

    Frozen shrimp in bulk packaging is recalled because it was manufactured under insanitary conditions and may have been contaminated with Cesium-137. 17,214 cases across all brands are affected.

    Product
    Frozen shrimp in bulk packaging. 20 lbs (10 x 2 lbs blocks); 20 lbs (20 x 1 lbs blocks); 9 lbs case UPC# SH0176; SH0430; SH0320; SH0369; SH0370
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2452-2025·2025-09-03

    Surgery trays recalled because they contain recalled tourniquet cuffs

    Medline General Surgery Trays are recalled because they contain recalled Stryker Color Cuff tourniquet cuffs whose flange may detach, compromising air pressure and risking tourniquet failure. 1,145 units are affected.

    Product
    The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2025·2025-09-03

    Laparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements

    American Contract Systems laparoscopy and pelviscopy procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,094 units are affected.

    Product
    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2419-2025·2025-09-03

    Light therapy devices recalled over welded nut that may shear off

    Two NovoTHOR Gen 3.0 Reg PRX units are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2418-2025·2025-09-03

    NovoTHOR Gen 3.0 unit recalled because gas strut may detach from canopy

    A single NovoTHOR Gen 3.0 Reg PRX unit, model S2189, is recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.

    Product
    Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2438-2025·2025-09-03

    Dialysis control units recalled over false blood leak detection alarms

    PrisMax V3 Control Units are recalled because of unexpected blood leak alarms when no leak is present, or difficulty normalizing the blood leak detector. 2,449 units are affected.

    Product
    PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2477-2025·2025-09-03

    Medication dispensing stations recalled because antivirus software was not consistently installed

    BD Pyxis MedStation and Anesthesia Station devices are recalled because antivirus software was not consistently installed during implementation. 8,353 devices are affected, 6,738 of them in the US.

    Product
    BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2475-2025·2025-09-03

    Anti-Xa test kits recalled over potential contamination by fibrinogen reagents

    STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 units are affected.

    Product
    STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0523-2025·2025-09-03

    Tzatziki sauce recalled because label omits keep refrigerated storage instruction

    Gelson's Tzatziki, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.

    Product
    Gelson's Tzatziki; Old-World Family Recipe Real Greek Yogurt California-Made; NET WT. 8OZ (226g) UPC: 23631-10268
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0524-2025·2025-09-03

    Low sodium classic hummus recalled over missing keep refrigerated storage instruction

    Gelson's Low Sodium No Cholesterol Classic Hummus, 10 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.

    Product
    Gelson's Hummus; Low Sodium No Cholesterol Classic NET WT 10OZ (283g) UPC: 23631-10260
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2422-2025·2025-09-03

    Atlantis IO FLO-S kits recalled over thread defect limiting implant engagement

    Atlantis IO FLO-S Kits, catalog A04S / 68020034, are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 780 units are affected.

    Product
    Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring che
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2421-2025·2025-09-03

    Dental implant locating kits recalled over thread defect limiting full engagement

    Atlantis IO FLO-S Kits are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 102 units are affected.

    Product
    Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0525-2025·2025-09-03

    Hummus recalled because labels omit keep refrigerated storage instructions

    Gelson's Hummus, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.

    Product
    Gelson's Hummus; Mediterranean Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10261
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2473-2025·2025-09-03

    Coagulation analyzers recalled over potential reagent contamination in anti-Xa testing

    STA Satellite analyzers are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 3,650 units are affected.

    Product
    STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2476-2025·2025-09-03

    Fibrinogen test kits recalled over potential cross-contamination in heparin assays

    STA-Fibrinogen 5 kits are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in heparin applications. 829,800 units are affected, 245,200 of them in the US.

    Product
    STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2025·2025-09-03

    Anti-Xa 4 test kits recalled over potential fibrinogen reagent contamination

    STA-Liquid Anti-Xa 4 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 116,600 units are affected.

    Product
    STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2025·2025-09-03

    NovoTHOR XL devices recalled over failed welded nut detaching gas strut

    NovoTHOR XL devices, model S2190, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 55 units are affected.

    Product
    Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2416-2025·2025-09-03

    NovoTHOR light therapy devices recalled over welded nut that may shear

    NovoTHOR devices, model S2188, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 80 units are affected.

    Product
    Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2461-2025·2025-09-03

    Surgical driver systems recalled over out of the box driver wobble

    IPC Powerease System units, REF 2300000, are recalled because of out of the box wobble of the driver. 214 units are affected.

    Product
    IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. The IPC POWEREASE S
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2437-2025·2025-09-03

    Hemodialysis delivery systems recalled over priming alarm requiring additional priming cycles

    PrisMax V2-US hemodialysis delivery systems are recalled because a low deaeration chamber level at post-priming tests may trigger alarm T2309, resulting in multiple additional priming cycles. 4,772 units are affected.

    Product
    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2453-2025·2025-09-03

    Drug transfer devices recalled for shipping without US instructions for use

    BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.

    Product
    BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0532-2025·2025-09-03

    Passionflower herb extract recalled over misbranding of the bulk ingredient

    Passionflower Herb Powdered Extract 4% in bulk packaging is recalled for misbranding of the ingredient. The recall covers 775 kg sent to a single consignee in North Carolina.

    Product
    Passionflower Herb Powdered Extract 4%, bulk packaging, individual large box, corrugated cardboard box with plastic liner .
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·H-0526-2025·2025-09-03

    Red bell pepper hummus recalled because label omits keep refrigerated instruction

    Gelson's Red Bell Pepper Hummus, 8 oz, sold in the firm's Southern California grocery stores, is recalled because the label does not carry the storage instruction to keep refrigerated.

    Product
    Gelson's Hummus; Red Bell Pepper Old World Family Recipe California-Made No Added Oils NET WT 8OZ (226g) UPC: 23631-10262
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2439-2025·2025-09-03

    Blood warmer units recalled because system may not detect inserted bag

    TherMax Blood Warmer Units, an accessory to the PrisMax system, are recalled because the system may be unable to detect a bag on the unit, causing setup difficulty or alarm T2284. 7,432 units are affected.

    Product
    TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2386-2025·2025-09-03

    mL26-8 transducer probes recalled to add field useful life labelling

    mL26-8 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    mL26-8 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2380-2025·2025-09-03

    L18-5 ultrasound transducer probes recalled to add useful life labelling

    L18-5 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    L18-5 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2366-2025·2025-09-03

    D2cwc transducer probes recalled to add useful life labelling

    D2cwc Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    D2cwc Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2356-2025·2025-09-03

    C6-3 transducer probes recalled for useful life labelling in the field

    C6-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    C6-3 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2411-2025·2025-09-03

    X7-2 transducer probes recalled over useful life labelling clarification

    X7-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    X7-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2394-2025·2025-09-03

    S5-2 transducer probes recalled to add useful life labelling

    S5-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S5-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2388-2025·2025-09-03

    OMNI III TEE transducer probes recalled to add useful life labelling

    OMNI III TEE Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    OMNI III TEE Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2392-2025·2025-09-03

    S4-1 Lumify transducer probes recalled to define transducer useful life

    S4-1 Lumify Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S4-1 Lumify Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2403-2025·2025-09-03

    V6-2 transducer probes recalled to clarify useful life in the field

    V6-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    V6-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2463-2025·2025-09-03

    Leg massagers recalled over documentation error and misleading color packaging claim

    HoMedics Air Compression Leg Massagers, model SR-160HJ, are recalled for a regulatory documentation error and a misleading color packaging claim. The record states the affected lots do not present a risk of harm.

    Product
    Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2346-2025·2025-09-03

    3D6-2 transducer probes recalled to add field useful life labelling

    3D6-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    3D6-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2401-2025·2025-09-03

    C10-3v transducer probe serial B2WXV7 recalled over useful life labelling

    The C10-3v Transducer Probe is the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    Transducer C10-3v Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2406-2025·2025-09-03

    X11-4t transducer probes recalled to add useful life labelling

    X11-4t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    X11-4t Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2360-2025·2025-09-03

    C9-2 transducer probes recalled to clarify useful life in the field

    C9-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    C9-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2379-2025·2025-09-03

    L17-5 ultrasound transducer probes recalled to add useful life labelling

    L17-5 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    L17-5 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2395-2025·2025-09-03

    S7-3t ultrasound transducer probes recalled to add useful life labelling

    S7-3t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S7-3t Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2414-2025·2025-09-03

    XL14-3 ultrasound transducer probes recalled to add useful life labelling

    XL14-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    XL14-3 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2352-2025·2025-09-03

    c5-1 transducer probes recalled for useful life labelling in the field

    c5-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    c5-1 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2404-2025·2025-09-03

    V9-2 transducer probes recalled to add useful life labelling

    V9-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    V9-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2391-2025·2025-09-03

    S4-1 transducer probes recalled for useful life labelling in the field

    S4-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S4-1 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2397-2025·2025-09-03

    S8-3 ultrasound probes recalled to add field useful life labelling

    S8-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S8-3 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2409-2025·2025-09-03

    X5-1c transducer probes recalled to clarify useful life in the field

    X5-1c Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    X5-1c Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2390-2025·2025-09-03

    S3-1 transducer probes recalled over useful life labelling clarification

    S3-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    S3-1 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2355-2025·2025-09-03

    C6-2 ultrasound probes recalled for useful life labelling in the field

    C6-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    C6-2 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2369-2025·2025-09-03

    eL18-4 transducer probes recalled to clarify useful life labelling

    eL18-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    eL18-4 Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2364-2025·2025-09-03

    C9-4v transducer probes recalled for useful life labelling clarification

    C9-4v Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.

    Product
    C9-4v Transducer Probe
    Category
    Medical Device
    Distribution
    Distributed nationwide

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