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 deaths or serious injuries are reported, 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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9126–9150 of 27393

  • 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-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-0148-2023·2022-11-09

    Transcutaneous monitor attachment rings recalled for weak skin adhesion

    SenTec AG voluntarily recalled 17,208 units of transcutaneous CO2/O2 monitor attachment rings due to weak skin adhesion. The devices, used in noninvasive patient monitoring, were distributed nationwide.

    Product
    sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2023·2022-11-09

    Surgical Kit Sterile Pouches with Seal Openings Recalled by Medline

    Medline is recalling approximately 160 surgical kits with defective breather pouches showing seal openings, potentially compromising sterility. The recall affects facilities in eight states nationwide.

    Product
    BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical 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-0158-2023·2022-11-09

    Surgical Cataract Pack Recalled Due to Compromised Sterile Packaging

    Medline Industries is recalling 300 units of Bausch + Lomb Cataract Packs due to breather pouches with seal openings that may compromise sterility. The affected surgical kits were distributed nationwide.

    Product
    BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
    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-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-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-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-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-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-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-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-0174-2023·2022-11-09

    BD Nexiva IV Catheter May Leave Needle Tip Exposed During Withdrawal

    The BD Nexiva Closed IV Catheter System tip shield may separate prematurely during needle withdrawal, leaving the needle tip exposed. This affects 56,080 units distributed across multiple U.S. states.

    Product
    BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
    Category
    Medical Device
    Distribution
    13 states
  • 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-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-0171-2023·2022-11-09

    BD Trucount Tubes for Blood Testing Recall Due to Label Detachment

    Becton, Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together or create automation errors. The defect stems from an adhesive supplier change and affects 52,570 units.

    Product
    BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the B
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0172-2023·2022-11-09

    BD Trucount Tubes Recalled Due to Partial Label Detachment Causing Operational Failures

    Becton Dickinson is recalling BD Trucount Tubes due to partial label detachment that can cause tubes to stick together in pouches or fail when used with automated loaders. No illnesses have been reported.

    Product
    BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the B
    Category
    Medical Device
    Distribution
    43 states
  • 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-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-0179-2023·2022-11-09

    Allen Life Assist Beach Chair Adhesive Cure Failure Recall

    Baxter Healthcare is recalling the Allen Life Assist Beach Chair due to adhesive on fasteners that may not cure correctly, potentially compromising the device's mechanical integrity during surgical procedures.

    Product
    Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the Fowlers or beach chair position.
    Category
    Medical Device
    Distribution
    4 states
  • 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
  • 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-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