The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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11526–11550 of 39932

  • HighFDA (Devices)·Z-0149-2023·2022-11-09

    EKOS Control Unit 4.0 Recalled for Missing or Incorrect Instructions

    Boston Scientific is recalling 16 EKOS Control Unit 4.0 consoles that were shipped without proper instructions for use or with incorrect instructions, creating risk of improper device operation.

    Product
    EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0146-2023·2022-11-09

    Fogarty Arterial Embolectomy Catheters Recalled for Latex Deterioration

    Edwards Lifesciences is recalling 715,620 Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration in the pouch packaging. The material degradation could affect device performance during use.

    Product
    Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2023·2022-11-09

    Cardiac Navigation Catheter Recalled for Cellulose Fiber Contamination

    Johnson & Johnson is recalling 91 THERMOCOOL SMARTTOUCH SF cardiac catheters nationwide due to manufacturing defects introducing cellulose fibers into the irrigation system. The contamination may prevent proper flushing, reduce cooling capability, or cause clotting complications.

    Product
    THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2023·2022-11-09

    Beach Chair Clamp Shoulder Positioner recalled for adhesive curing failure

    Baxter Healthcare recalls Beach Chair Clamp shoulder positioner components because adhesive on the fasteners may not cure properly, potentially reducing the device's mechanical integrity during surgical procedures.

    Product
    Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0177-2023·2022-11-09

    Allen Spine Positioner Components Recalled for Adhesive Curing Defect

    Baxter Healthcare is recalling Allen Standard Starburst spine positioning components due to adhesive that may not cure correctly, potentially compromising mechanical holding force in surgical head positioning devices.

    Product
    Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0167-2023·2022-11-09

    NICU PICC Insertion Bundle Recalled for Breather Pouch Seal Defects

    Medline Industries recalls NICU PICC insertion bundles (50 kits) due to openings in breather pouch seals that compromise sterile barrier integrity. This Class II recall affects units distributed across the United States.

    Product
    CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2023·2022-11-09

    Medline LINQ Surgical Trays Recalled for Compromised Pouch Seals

    Medline has recalled LINQ TRAY surgical kits with breather pouch seal openings that could compromise sterility. The recall affects 40 kits distributed nationwide; no injuries have been reported.

    Product
    MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2023·2022-11-09

    Surgical Cataract Kits Recalled for Defective Breather Pouch Seals

    Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.

    Product
    BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2023·2022-11-09

    Surgical eye kits recalled for breached sterile pouches

    Medline Industries recalls Bausch + Lomb eye muscle surgical kits due to breached breather pouches that may compromise sterility. The affected kits (Lot 22DBN366) were distributed nationwide.

    Product
    BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0161-2023·2022-11-09

    Surgical Cataract Packs with Compromised Breather Pouch Seals Recalled

    Medline recalls 708 Bausch + Lomb cataract surgical packs due to breather pouch seal defects that could compromise sterility of surgical instruments.

    Product
    BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2023·2022-11-09

    Boston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error

    Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires replacement.

    Product
    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2023·2022-11-09

    Medline Dental Pack Recall Due to Breather Pouch Seal Defect

    Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.

    Product
    MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2023·2022-11-09

    Baxter Neurosurgical Headrest Recalled Due to Defective Adhesive

    Baxter Healthcare is recalling C-Flex Polar Head Positioning Device neurosurgical headrests because adhesive on fasteners may not cure correctly, potentially compromising mechanical integrity and holding force.

    Product
    C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0155-2023·2022-11-09

    Surgical Eye Kit Pouches Recalled for Seal Defects

    Medline recalls Bausch + Lomb Eye surgical kits due to breather pouches with openings in the seal. Affected kits were distributed to healthcare facilities nationwide; unopened kits should not be used.

    Product
    BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2023·2022-11-09

    Surgical Positioning Clamp Adhesive May Fail to Cure Properly

    Baxter Healthcare is recalling Simple Clamp surgical positioning equipment because the adhesive may not cure properly, reducing mechanical integrity during use. Affected units were distributed across multiple US states and international locations.

    Product
    Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0150-2023·2022-11-09

    STRATAFIX Absorbable Sutures Recalled for Wrong Needle Type

    Ethicon recalls STRATAFIX absorbable sutures after discovering some packages contain the wrong needle type. The PS-1 cutting edge needle instead of the intended SH taper point needle may cause more tissue trauma than anticipated.

    Product
    STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0166-2023·2022-11-09

    Medline CVC Barrier Kit Recalled for Breached Pouch Seals

    Medline is recalling CVC barrier kits (Lot 22ABT774) due to breather pouches with seal openings that could compromise sterility of the surgical kit contents.

    Product
    MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2023·2022-11-09

    Medline Radiology Procedure Pack Breather Pouches Recalled for Seal Defects

    Medline is recalling 240 Radiology Procedure Packs because some breather pouches show seal openings that could compromise sterility. The affected kits were distributed nationwide.

    Product
    MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2023·2022-11-09

    Operating Room Table With Defective Adhesive May Lose Mechanical Integrity

    Baxter Healthcare is recalling Allen Advance operating room tables because adhesive securing fasteners may not cure properly, potentially compromising mechanical integrity.

    Product
    Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0152-2023·2022-11-09

    Implantable Defibrillator Software Error Causes Inaccurate Battery Display

    Boston Scientific's EMBLEM MRI S-ICD implantable defibrillators contain a software defect with an incorrect manufacturing date that causes inaccurate battery capacity display. The recall affects 142 devices distributed worldwide.

    Product
    EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2023·2022-11-09

    Medline Lithotomy Sterile Surgical Kit Recalled for Compromised Breather Pouch Seal

    Medline is recalling 96 sterile surgical kits (REF DYNJ50099C, Lot 22DBL482) distributed nationwide due to complaints of openings in breather pouches that compromise sterility and increase contamination risk.

    Product
    MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2023·2022-11-09

    Fogarty Biliary Balloon Probes recalled for latex deterioration

    Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.

    Product
    Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2023·2022-11-09

    Pediatric Vision Scanner Battery Pack Poses Fire Risk

    Rebiscan is recalling Blinq Pediatric Vision Scanners (Model BQ830) because the battery pack may vent and catch fire if a cell voltage drops below 2.5V.

    Product
    Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2023·2022-11-09

    BD Multitest 6-Color TBNK tubes recalled for partial label detachment

    BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.

    Product
    BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0124-2023·2022-11-02

    Medline Pre-Op CHG Bathing Kit recalled for incorrect expiration dates

    Medline is recalling 460 Pre-Op CHG Bathing Kits because the CHG solution and blood culture bottles have expiration dates that don't match the kit label. Expired components could compromise effectiveness.

    Product
    MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
    Category
    Medical Device
    Distribution
    Distributed nationwide