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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8401–8425 of 27393

  • HighFDA (Devices)·Z-1158-2023·2023-03-01

    IV Access Device Kit Recalled Due to Manufacturing Defect in Connector

    Cardinal Health is recalling Presource Packs IV START TRAY I kits due to a manufacturing defect in the ICU MicroClave Clear Connector that may cause fluid leaks and loss of fluid path integrity.

    Product
    Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2023·2023-03-01

    Hepatitis B Diagnostic Test Kits Recalled for Test Interference

    Siemens is recalling ADVIA Centaur diagnostic test kits used to detect hepatitis B antibodies due to test interference that can produce false positive results when performed before another hepatitis B test on the same sample.

    Product
    ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin. Siemens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2023·2023-02-22

    Surgical convenience kits recalled for compromised external packaging sterility

    Medline Industries is recalling 1,588 surgical kits nationwide due to a perforated bag design that prevents the outside of the kit wrapping from remaining sterile.

    Product
    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2023·2023-02-22

    SIEMENS Biograph Horizon 3R Mobile PET gantry locking mechanism defect

    Siemens is recalling the Biograph Horizon 3R Mobile PET/CT system due to a potential failure of the locking mechanism that secures the PET gantry in its scanning or service position. The system has been distributed worldwide.

    Product
    SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2023·2023-02-22

    Medline Surgical Convenience Kits Recalled for Sterility Compromise

    Medline Industries is recalling 981 surgical convenience kits nationwide because the perforated outer bag does not maintain sterile conditions. Only the kit contents remain sterile, not the exterior wrapping.

    Product
    Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2023·2023-02-22

    iTotal Identity Impactor Handle surgical screws may loosen during procedures

    Conformis Inc. is recalling the iTotal Identity Impactor Handle due to potential loose screws that could fall into patients during surgical procedures. Approximately 70 units from lot D221301 were distributed across multiple U.S. states.

    Product
    iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2023·2023-02-22

    Surgical Instrument Trays Recalled for Compromised Outer Bag Sterility

    Medline Industries recalls CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAYS due to a perforated outer bag that fails to maintain sterility. While the inner contents remain sterile, the compromised outer bag could contaminate instruments during surgical procedures.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1122-2023·2023-02-22

    Medline Surgical Shoulder Suspension Kits Recalled for Sterility Compromise

    Medline is recalling 1,280 SHOULDER SUSPENSION surgical kits nationwide due to a defective perforated bag that fails to maintain sterility on the kit's exterior, potentially compromising the sterile contents inside.

    Product
    Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2023·2023-02-22

    Surgical Convenience Kits Recalled for Outer Wrapping Sterility Defect

    Medline is recalling 1376 surgical convenience kits nationwide due to a packaging defect that compromises the sterility of the outer wrapping. Only the kit contents remain sterile.

    Product
    Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1136-2023·2023-02-22

    Siemens Biograph Vision PET Scanner Gantry Locking Mechanism Recall

    Siemens recalls Biograph Vision PET scanners worldwide for a potential defect in the gantry locking mechanism that secures the equipment during scanning and service.

    Product
    SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2023·2023-02-22

    Medline CABG surgical convenience kits recalled due to sterility issue

    Medline is recalling 80 units of MEDLINE CABG PACK surgical convenience kits (Lot #22HMH432) nationwide because the perforated bag design cannot maintain sterility of the outer packaging wrapping.

    Product
    Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2023·2023-02-22

    MicroPort Recalls Evolution MP Tibial Bases Due to Wrong Size in Packaging

    MicroPort Orthopedics is recalling lot 1916715 of EVOLUTION MP Tibial Bases (size 7) due to a packaging error where the wrong-sized implant component was found in a package. A confirmed incident involved discovery during surgery.

    Product
    EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1132-2023·2023-02-22

    Olympus colonovideoscope recalled for potential microbial contamination from veterinary use

    An Olympus EVIS EXERA III colonovideoscope was used in veterinary endoscopy before being designated as a medical facility loaner, creating potential for microbial contamination.

    Product
    EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2023·2023-02-22

    Medline surgical convenience kits recalled for inadequate exterior sterility

    Medline is recalling surgical convenience kits because the perforated bag does not maintain sterility of the kit's exterior wrapping. Only the contents inside the wrapping are sterile.

    Product
    Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2023·2023-02-22

    Surgical Convenience Kits Recalled for Compromised Sterility Assurance

    Medline Industries is recalling surgical convenience kits with reorder number DYNJCD0063 due to a perforated bag that fails to keep the kit's outer wrapping sterile. Affected units were distributed nationwide.

    Product
    Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2023·2023-02-22

    HydroPICC Catheter Recall Due to Incorrect Expiration Dates on Select Lots

    Select lots of HydroPICC 4Fr catheters are mislabeled with expiration dates that exceed their actual expiration. Affected units should not be used.

    Product
    HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0277-2023·2023-02-22

    Orthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction

    OrthoPediatrics has recalled Orthex Large Bone Shoulder Bolts due to breakage risk that may disrupt bone correction and healing. Affected units were distributed in the United States and internationally.

    Product
    Orthex Large Bone Shoulder Bolt, model no. AS-17
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1129-2023·2023-02-22

    HydroMID 4Fr Catheters Recalled for Incorrect Expiration Dating

    Access Vascular is recalling select lots of HydroMID 4Fr catheters because they are labeled with incorrect expiration dates—the devices expire before the labeled dates. This creates a risk of using expired medical equipment in clinical settings.

    Product
    HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2023·2023-02-22

    Potential Gantry Locking Mechanism Defect in SIEMENS Biograph mCT PET Scanners

    The SIEMENS Biograph mCT PET scanner has a potential issue with the locking mechanism that secures the gantry. Six units distributed worldwide including the US, Japan, Chile, and Australia are affected.

    Product
    SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2023·2023-02-22

    Surgical Breast Biopsy Kits Recalled Due to Non-Sterile Outer Wrapping

    Medline Industries is recalling 60 units of its Breast Biopsy Kit nationwide because the outer wrapping is not sterile. Only the kit's contents maintain sterility.

    Product
    Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1119-2023·2023-02-22

    Surgical kits recalled due to compromised sterile wrapping

    Medline Industries is recalling multiple CENTURION MEDICAL PRODUCTS surgical kits because perforated packaging compromises the sterile barrier. Only contents inside the kit wrapping maintain sterility.

    Product
    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURIO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2023·2023-02-22

    Surgical Tracheostomy Kit Recalled Due to Perforated Outer Wrapping Compromising Sterility

    Medline Industries has recalled 120 units of Centurion Medical Products Tracheostomy Tray due to a perforated outer bag that prevents the exterior from remaining sterile, though the kit contents remain sterile.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0275-2023·2023-02-22

    EVOLUTION MP Tibial Base knee component recalled for wrong product in packaging

    MicroPort Orthopedics is recalling EVOLUTION MP Tibial Base knee prosthesis components due to a packaging error where a wrong-sized component was placed inside product boxes. One incident was discovered during surgery.

    Product
    EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1113-2023·2023-02-22

    Neonatal PICC Surgical Kits Recalled for Non-Sterile External Packaging

    Medline Industries is recalling CENTURION MEDICAL PRODUCTS neonatal PICC surgical kits because the perforated bag fails to maintain sterility on the exterior packaging. Only contents inside are sterile.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2023·2023-02-22

    Surgical convenience kits recalled due to sterile packaging failure

    Medline Industries is recalling 138 surgical convenience kits nationwide because the outer packaging does not maintain sterility. Only the contents inside the kit wrapper are sterile, creating a contamination risk.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065
    Category
    Medical Device
    Distribution
    Distributed nationwide