The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

16426–16450 of 53092

  • HighFDA (Devices)·Z-1474-2022·2022-08-03

    Medline Convenience Surgical Kits Recalled Due to Leaking Isopropyl Alcohol

    Medline Convenience surgical kits containing leaking bottles of isopropyl alcohol are being recalled nationwide. The leaking alcohol poses a risk of chemical exposure to healthcare workers and potential contamination of the surgical field.

    Product
    Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. PRE-OP ACCESSORY KIT CHOICE, f. DEEP BRAIN STIMULATION PACK, g. DEEP BRAIN STIMULATION PACK, h. MINIMALLY INVASIVE PACK-LF, i.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1294-2022·2022-08-03

    Jubilant Cadista Irbesartan tablets recalled due to failed dissolution

    Jubilant Cadista Pharmaceuticals is recalling 28,560 bottles of Irbesartan 75 mg tablets nationwide due to failed dissolution specifications that may compromise drug efficacy.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2022·2022-08-03

    Medical imaging software may flip left-right brain image orientation

    NordicBrainEX software versions 2.21-2.3.10 may export brain imaging with reversed left-right orientation in certain analysis scenarios, potentially causing diagnostic misinterpretation.

    Product
    nordicBrainEX, software versions 2.21 through 2.3.10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1289-2022·2022-08-03

    Prescription testosterone gel recalled due to out-of-specification potency

    Teva Pharmaceuticals is recalling testosterone gel lot 1403180 after stability testing revealed out-of-specification assay results indicating superpotency. The affected 12,354 cartons were distributed nationwide.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2022·2022-08-03

    Medline Medical Convenience Kits Recalled for Leaking Isopropyl Alcohol Bottles

    Medline is recalling medical convenience kits distributed nationwide that contain leaking bottles of isopropyl alcohol. Users should stop using the affected kits.

    Product
    Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2022·2022-08-03

    Dialysis Machine Recalled for Electrical Shock Risk in AquaC UNO H

    The FDA is recalling 277 Fresenius AquaC UNO H dialysis machines due to misaligned internal ethernet cables that could expose the external port to electrical current, creating a shock risk for service technicians.

    Product
    AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2022·2022-08-03

    HammerTube 2.75mm Implant Recalled for Missing Titanium Plasma Coating

    Paragon 28 recalls HammerTube implants missing their titanium plasma coating. Affected implants were distributed to facilities in Alabama, California, Georgia, Illinois, and Kentucky.

    Product
    HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2022·2022-08-03

    TruClear Hysteroscopic Tissue Removal Control Unit Electrical Failure

    Covidien is recalling 33 TruClear Hysteroscopic Tissue Removal System Control Units due to electrical component failure causing loss of device function during surgery. The affected units were distributed to multiple U.S. states and foreign countries.

    Product
    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1479-2022·2022-08-03

    Revogene diagnostic test instrument recalled for burn risk from cooling failure

    Meridian Bioscience recalled 459 Revogene diagnostic instruments due to a cooling protection failure that may expose users to heated components, risking minor burn injuries.

    Product
    Revogene, Catalog no. 610210. IVD test instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1508-2022·2022-08-03

    Bumble Bee Smoked Clams recalled for detectable PFAS contamination

    Bumble Bee Smoked Clams (3.75 oz) are recalled due to detectable levels of per- and polyfluoroalkyl substances (PFAS). The recall affects U.S. distribution to 13 states.

    Product
    Bumble Bee Smoked Clams Shucked Easy Open NET WT. 3.75 oz. (106 g) Distributed By: Bumble Bee Seafoods San Diego, CA 92186 USA Product of China UPC 0 86600 75234 1
    Category
    Food
    Distribution
    13 states
  • HighFDA (Drugs)·D-1291-2022·2022-08-03

    FDA Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Sun Pharmaceutical recalls Divalproex Sodium delayed-release tablets due to failed dissolution specifications discovered during stability testing. The tablets may not dissolve as intended.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1460-2022·2022-08-03

    Da Vinci Surgical Clip Appliers Recalled for Potential Unexpected Motion

    Intuitive Surgical is recalling three models of Da Vinci clip appliers due to potential unexpected motion from partial instrument disengagement. Approximately 90,628 units have been distributed worldwide.

    Product
    Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2022·2022-08-03

    X-Stream Irrigation System recalled due to potential fire hazard

    Davol, Inc. is recalling the X-Stream Irrigation System due to a potential fire hazard. The device may cause a fire during use, creating a safety risk.

    Product
    X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1456-2022·2022-08-03

    Alinity c Hemoglobin Reagent Kit Recall Due to Potentially Falsely Elevated Results

    Abbott Laboratories is recalling Alinity c Hemoglobin Reagent Kits (lots 59801UQ04 and 60763UQ09) due to a potential for falsely elevated hemoglobin A1c test results when used with ARCHITECT and Alinity c analyzers.

    Product
    REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-1478-2022·2022-08-03

    Stryker Craniotomy Router May Break and Leave Metal Fragments

    Stryker 2.3mm Tapered Router (craniotomy instrument) may break due to undersized core, leaving metal fragments in the surgical site. This risks damage to critical brain structures or need for additional surgery.

    Product
    Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2022·2022-08-03

    Medline medical device kits recalled for leaking isopropyl alcohol bottles

    Medline Industries is recalling medical convenience kits containing leaking bottles of isopropyl alcohol due to chemical exposure risk. The recall affects 288 units distributed nationwide.

    Product
    Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot codes: 22OBG246, 21LBU048, 21GBI196, 21KBK242, 21EBH567 Model/Catalog Number: a. Model Number DYNJ36725B, b. Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2022·2022-08-03

    Medline LAP CHOLE convenience kits recalled for leaking isopropyl alcohol

    Medline is recalling LAP CHOLE convenience kits due to leaking bottles of isopropyl alcohol. The affected kits were distributed nationwide.

    Product
    Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2022·2022-08-03

    AquaC UNO H Dialysis Machine Recalled Due to Electrical Shock Risk

    Fresenius is recalling 318 AquaC UNO H dialysis machines nationwide due to a potential electrical shock hazard affecting service technicians and operators. An internal ethernet cable may become misaligned, damaging insulation and creating an electrical hazard when the external port is touched.

    Product
    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V563000·2022-08-02

    2021 Mitsubishi Outlander Sport CVT transmission software defect causes engine stall

    Mitsubishi is recalling 2019-2022 Outlander Sport vehicles for a software error in the transmission control unit that may cause engine stall at high speeds, increasing crash risk. Approximately 76,508 vehicles are affected.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V562000·2022-08-02

    Forest River Wildwood awning rail may detach while in motion

    Forest River is recalling certain 2021-2022 Wildwood and Salem fifth wheel trailers. The awning rail may detach while the vehicle is in motion, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V559000·2022-08-01

    Coachmen V-TREC Camping Trailers: Defective Pull-Out Bunk Beds

    Forest River is recalling certain 2022 Coachmen camping trailers with improperly laminated pull-out bunk beds that may not support weight as intended. The defective bunks could collapse during use, increasing the risk of injury.

    Product
    COACHMEN — COACHMEN CLIPPER, V-TREC, VIKING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·024-2022·2022-07-30

    Rachael's Food Corporation Recalls Ready-to-Eat Meat and Poultry Wraps

    Rachael's Food Corporation is recalling ready-to-eat meat and poultry wraps due to possible Listeria monocytogenes contamination. The products were distributed in Connecticut, Massachusetts, Rhode Island, and New York.

    Product
    Rachael's Food Corporation — Rachael’s Food Corporation Recalls Ready-To-Eat Meat and Poultry Wrap Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states