The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

21751–21775 of 88183

  • HighFDA (Devices)·Z-0228-2023·2022-11-23

    TufTex Embolectomy Catheter Recalled for Inadequate Ligature Ties

    LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.

    Product
    TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0239-2023·2022-11-23

    Operating Table Extension Tabletop May Drop, Creating Patient Fall Hazard

    The back rest of Getinge operating table extension tabletops may drop unexpectedly, posing a fall hazard to patients. No injuries have been reported.

    Product
    Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2023·2022-11-23

    CareFusion Genesis Sterile Containers Fail Sterilization Testing Requirements

    Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.

    Product
    CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0162-2023·2022-11-23

    Similac Special Care infant formula recalled for compromised seal

    Abbott Laboratories is recalling Similac Special Care 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Affected bottles have batch number 41861N200 with a best-by date of 06/01/23.

    Product
    Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0214-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion Genesis sterilization containers have failed to consistently meet aerosol challenge testing, potentially leaving surgical instruments inadequately sterilized. 318 units distributed in the US and internationally.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0200-2023·2022-11-23

    Endo Stitch V-Loc 180 Sutures Recalled for Needle Breakage During Use

    Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and requiring additional imaging.

    Product
    Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0153-2023·2022-11-23

    Nash Family Creamery Ranch Cheese Curd recalled for undeclared soy

    Nash Family Creamery Ranch Cheese Curd 8oz bags are recalled due to undeclared soy allergen. The product was distributed to Tennessee and Kentucky.

    Product
    Nash Family Creamery Ranch Cheese Curd packaged in 8oz plastic bag
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0219-2023·2022-11-23

    CareFusion Genesis sterilization containers fail aerosol challenge test requirements

    CareFusion Genesis reusable sterilization containers have not consistently passed aerosol challenge testing, which verifies their ability to properly sterilize medical instruments. Approximately 537 units were distributed internationally.

    Product
    CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0246-2023·2022-11-23

    OneLIF Torque Limiting Adapter Recalled for Potential Locking Failure

    Novapproach Spine is recalling OneLIF Torque Limiting Adapter components used in spinal surgery instruments because the adapter may not remain locked in the ratcheting handle once fully engaged. This could compromise surgical instrument function during use.

    Product
    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0203-2023·2022-11-23

    CareFusion Genesis Mini Sterilization Containers fail aerosol testing

    CareFusion Genesis Mini Containers used for surgical instrument sterilization have not consistently met aerosol challenge testing requirements, which may affect their ability to protect instruments during sterilization.

    Product
    CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0155-2023·2022-11-23

    Pedialyte Unflavored 2 fl oz bottles recalled due to seal integrity defect

    Abbott Laboratories recalls Pedialyte Unflavored 2 fl oz bottles for compromised seal integrity that could allow spoilage. Affected bottles were distributed across the United States and multiple countries.

    Product
    Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-0158-2023·2022-11-23

    Similac Infant Formula Recalled Due to Compromised Seal Integrity

    Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 15.9 million bottles are affected across the United States and international locations.

    Product
    Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0227-2023·2022-11-23

    Teleflex RUSCH Pocket Pac Urinary Catheter Kit Recalled for Sterility Concerns

    Teleflex Medical recalled approximately 7,200 RUSCH Pocket Pac i.c. urinary catheter kits due to potential sterility issues. Patients should contact their healthcare provider and discontinue use.

    Product
    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0215-2023·2022-11-23

    GENESIS Full-Length Sterilization Containers recalled for failed aerosol testing

    CareFusion 2200 Inc recalls GENESIS sterilization containers (model CD3-7ST, all lots) that have not consistently met aerosol challenge testing requirements required for proper sterilization efficacy.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0213-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Validation Testing

    CareFusion GENESIS sterilization containers have failed aerosol challenge testing for STERRAD sterilization validation. The recall affects 451 units distributed in the US and 17 other countries.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0241-2023·2022-11-23

    GI4000 Electrosurgical Unit recalled due to power regulator failure risk

    Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.

    Product
    GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2023·2022-11-23

    Infection Control Lifting Strap Recalled for Patient Safety Risk Due to Breakage

    Tollos is recalling Infection Control (IC) Lifting Straps used with certain Cirrus and Pinnacle ceiling lifts because the straps can break during patient lifts, potentially causing patients or caregivers to be injured by falls.

    Product
    Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2023·2022-11-23

    EasyStand Bantam standing devices may fail to maintain upright position

    Altimate Medical is recalling EasyStand Bantam Small and Extra Small standers due to a component defect that may prevent the leg assembly bracket from maintaining the non-supine position. No injuries have been reported.

    Product
    EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-0157-2023·2022-11-23

    Similac 360 Total Care Infant Formula Recalled for Compromised Bottle Seals

    Abbott Laboratories is recalling batches of Similac 360 Total Care and Total Care Sensitive infant formula 2 fl oz discharge kits for compromised seal integrity that could allow spoilage. The affected batch is identified by product code 39480N200 with a Best By date of 04/01/23.

    Product
    Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0233-2023·2022-11-23

    GentleWave System APM Procedure Instruments recalled for erroneous carton labels

    Sonendo Inc is recalling 15 GentleWave System APM Procedure Instruments (Model GW-APM-PI02) due to erroneous unit carton labels. The instruments were distributed worldwide, including Ohio and Canada.

    Product
    GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0065-2023·2022-11-23

    Neostigmine Injection Recall for Potential Cross-Contamination Due to Manufacturing Controls

    Nephron Sterile Compounding Center is recalling 56,220 vials of PF-Neostigmine Methylsulfate Injection due to potential cross-contamination from manufacturing control deviations.

    Product
    PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0165-2023·2022-11-23

    Similac Water bottles recalled for compromised seal integrity

    Abbott Laboratories is recalling specific lots of Similac Water due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed across the US, territories, and international locations.

    Product
    Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0234-2023·2022-11-23

    GentleWave System Posterior Procedure Instrument Recall for Erroneous Carton Labels

    Sonendo Inc is recalling 16 GentleWave System Posterior CleanFlow procedure instruments with lot number W2022080204R due to erroneous unit carton labels that could affect proper identification and use.

    Product
    GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2023·2022-11-23

    Atrium Ocean Wet Suction Chest Drains recalled due to storage temperature excursions

    Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States due to warehouse temperature excursions in July and August 2021. No patient harm has been reported.

    Product
    Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide