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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9801–9825 of 13731

  • HighFDA (Devices)·Z-1196-2023·2023-03-08

    Vascular diagnostic device recalled for air line misconnection risk

    Unetixs Vascular is recalling the MultiLab Series II REVO vascular diagnostic device because faulty connectors may allow the air line to be misconnected to an IV line, potentially causing a dangerous air embolism.

    Product
    MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2023·2023-03-08

    Summit Medical Nasal Septal Button Recall: Unsealed Sterile Pouches

    Summit Medical is recalling 30 Nasal Septal Buttons due to unsealed sterile pouches that compromise product sterility. Patients face potential infection risk from non-sterile device exposure.

    Product
    Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1187-2023·2023-03-08

    EMPOWR VVC Knee Tibial Insert Recalled for Reversed Box Labeling

    Encore Medical recalls EMPOWR VVC Knee Tibial Inserts due to reversed box labeling—large inserts marked as small and vice versa. Surgeons may implant the wrong size if the labeling discrepancy is not identified before surgery.

    Product
    EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, S
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1205-2023·2023-03-08

    Sit to Stand STS500 Patient Lift Recalled Due to Loose Boom Fasteners

    Med-Mizer is recalling 37 units of the Sit to Stand STS500 Patient Lift due to risk of boom pivot failure caused by a loose securing nut and unsecured bolt on the boom flange.

    Product
    Sit to Stand STS500 Patient Lift
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1202-2023·2023-03-08

    Phoenix mKDR Mobile Diagnostic X-ray System Recalled for Erratic Movements

    SEDECAL SA is recalling 53 units of the Phoenix mKDR mobile diagnostic x-ray system following 3 incidents of erratic movements. Facilities using the affected equipment should discontinue use and contact the manufacturer.

    Product
    Phoenix mKDR, digital mobile diagnostic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1203-2023·2023-03-08

    FDA Recalls Mobile X-Ray System for Erratic Movement Risk

    SEDECAL's Phoenix mKDR Xpress mobile x-ray system is recalled due to three reported incidents of erratic movements. Seven units distributed in the US, Argentina, and Panama are affected.

    Product
    Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1174-2023·2023-03-08

    Monosof nylon sutures recalled for sterile barrier breach

    Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.

    Product
    Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1178-2023·2023-03-08

    Surgilon Braided Nylon sutures recalled due to sterile barrier defect

    Covidien is recalling Surgilon Braided Nylon sutures due to a sterile barrier breach in the breather pouch that could allow bacterial contamination, potentially causing infection or vision loss in ophthalmic procedures.

    Product
    Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2023·2023-03-08

    Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules

    Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.

    Product
    MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2023·2023-03-08

    X-ray System Overhead Crane May Continue Moving Unexpectedly

    Carestream Health is recalling certain DRX-Compass/DR-FIT X-ray systems because the overhead tube crane may unexpectedly continue moving after Z-axis motorized buttons are pressed and released, potentially causing injury.

    Product
    DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2023·2023-03-08

    Stryker Blood Loss Estimator Inserts Recalled for Inaccurate Measurement

    Stryker is recalling Medivac Guardian 2L blood loss estimator inserts and labels for measurement inaccuracy. The device may output incorrect estimates, potentially delaying postpartum hemorrhage treatment.

    Product
    Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2023·2023-03-08

    Ti-Cron Surgical Sutures Recalled Due to Sterile Barrier Breach

    Covidien is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. The defect could allow bacterial contamination, posing a risk of infection or vision loss during ophthalmic procedures.

    Product
    Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TIC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2023·2023-03-08

    Dental Handpieces Recalled Due to Detachable Screw Component Risk

    Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 dental handpieces because the screw connection between the turbine head and push button may loosen and fall off, creating a risk of swallowing or inhaling these parts.

    Product
    SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1183-2023·2023-03-08

    Surgical Mesh Recalled Due to Incorrect Collagen Film Placement

    Covidien is recalling Parietex Composite Mesh because the collagen film was positioned on the wrong side, which may cause delays in treatment, adhesions, erosion, migration, pain, fistula, hernia recurrence, or implant failure.

    Product
    Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1172-2023·2023-03-08

    Dermalon Surgical Sutures recalled for sterile barrier breach

    Covidien is recalling Dermalon monofilament nylon sutures due to a breach in the sterile barrier of the breather pouch. Affected units may cause infection or vision loss if used in ophthalmic procedures involving direct patient contact.

    Product
    Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2023·2023-03-08

    Vascular diagnostic devices recalled due to air embolism misconnection risk

    Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.

    Product
    MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2023·2023-03-08

    Custom Suture Packs recalled due to sterile barrier breach risk

    Covidien Custom Suture Packs (US1638 and US1756) are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.

    Product
    Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2023·2023-03-08

    Orthopedic Bone Fixation Plates Recalled for Incorrect Product Packaging

    Wright Medical Technology recalls ORTHOLOC 3DSi CLAW II bone fixation plates due to incorrect products placed in packages. Healthcare providers should verify product identification matches packaging before use.

    Product
    ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2023·2023-03-08

    Medical Device Recall: Vascular Diagnostic Device Air Embolism Risk

    Unetixs Vascular is recalling 1706 units of the MultiLab Series II 2CP & 2CP Express vascular diagnostic device due to luer fittings that could allow air lines to be misconnected to intravenous lines, potentially causing air embolism.

    Product
    MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2023·2023-03-08

    Sofsilk Coated Braided Silk Sutures recalled for sterile barrier breach

    Covidien is recalling Sofsilk Coated Braided Silk Sutures due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss during ophthalmic procedures involving direct patient contact.

    Product
    Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2023·2023-03-08

    Contact Lenses Recalled for Misaligned Axis Causing Poor Vision

    CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.

    Product
    Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1186-2023·2023-03-08

    Triton Canister Software Labeling May Cause Inaccurate Blood Loss Estimates

    Stryker is recalling Triton Canister Software due to labeling issues that may cause inaccurate blood loss estimates. This could delay recognition of or prolong postpartum hemorrhage, potentially requiring more aggressive treatment.

    Product
    Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2023·2023-03-08

    Alaris PC Unit 8015 wireless network connectivity failure affecting infusion pump management

    Certain Alaris PC Unit 8015 infusion pump computers with specific wireless network cards may lose network connectivity, preventing remote infusion programming and data transfer. Manual programming of infusions may be required.

    Product
    Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1199-2023·2023-03-08

    Ultracell Wick with Collection Bag Recalled for Compromised Packaging Sterility

    Beaver Visitec International recalls Ultracell Wick with 80cc Collection Bag due to packaging with potentially open seals that may compromise product sterility. The recall affects 4,640 units distributed across the United States and internationally.

    Product
    Ultracell Wick with 80cc Collection Bag, 20/box
    Category
    Medical Device
    Distribution
    27 states
  • SevereFDA (Devices)·Z-1137-2023·2023-03-01

    NovaStar TS Anti-Asphyxia Valve recalled for magnetic interference risk

    Draeger Medical recalls NovaStar TS Anti-Asphyxia Valves due to magnets that may interfere with implanted and non-implanted medical devices and metallic implants.

    Product
    NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
    Category
    Medical Device
    Distribution
    Distributed nationwide