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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8351–8375 of 27393

  • 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-1170-2023·2023-03-08

    Bone fixation plates recalled due to product packaging mix-up

    Wright Medical Technology is recalling ORTHOLOC 3DSi CLAW II bone fixation plates due to packaging mix-up in specific lots. Packages contained incorrect product codes.

    Product
    ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
    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-1188-2023·2023-03-08

    Maquet CARDIOHELP System extracorporeal support device components recalled for sterility

    Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.

    Product
    BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
    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-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-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-1179-2023·2023-03-08

    Surgipro Monofilament Polypropylene Sutures Recalled for Sterile Barrier Breach

    Surgipro Monofilament Polypropylene Sutures are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.

    Product
    Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1200-2023·2023-03-08

    CustomEyes kits recalled due to potential sterility compromise

    Beaver Visitec International is recalling 4640 units of CustomEyes kits because packaging may contain open seals that could compromise product sterility. Affected units were distributed to 26 U.S. states and internationally.

    Product
    CustomEyes kits
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1180-2023·2023-03-08

    Surgipro II Surgical Sutures recalled for sterile barrier breach

    Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.

    Product
    Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X
    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-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-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-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-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-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-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-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-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-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-1185-2023·2023-03-08

    Medivac Guardian blood loss estimation device inserts may provide inaccurate readings

    Stryker's Medivac Guardian 3L scanning labels may cause inaccurate blood loss estimates, potentially delaying treatment for postpartum hemorrhage. The recall affects 541 units distributed nationwide.

    Product
    Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
    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-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-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