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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24326–24350 of 40299

  • ModerateFDA (Devices)·Z-1283-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04020-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1290-2018·2018-04-11

    Aesculap DS Titanium Ligation Clips Recalled for Contraindication Update

    Aesculap Implant Systems LLC is recalling DS Titanium Ligation Clips to update instructions for use, adding a contraindication for living donor nephrectomies.

    Product
    DS Titanium Ligation Clip, used in laparoscopic surgery
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1311-2018·2018-04-11

    Roche Recalls Elecsys BRAHMS PCT Immunoassay Due to Decreased Sample Recovery

    Roche Diagnostics is recalling 47 units of the Elecsys BRAHMS PCT Immunoassay because it shows decreased recovery of patient samples on the cobas e 801 module compared to other analyzers.

    Product
    Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1306-2018·2018-04-11

    Zimmer Biomet Recalls A.L.P.S. Calcaneus Locking Plate Guide Inserts

    Zimmer Biomet is recalling 22 A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts due to incorrect color anodization.

    Product
    A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1276-2018·2018-04-11

    Phadia Prime software recall for EliA assay retesting function

    Phadia Ab is recalling Phadia Prime software versions up to 2.1.4 to prevent the use of the 'OK to All' function when rejecting and retesting EliA assay samples.

    Product
    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1286-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2018·2018-04-11

    Arrow Arterial Access Tray Recall for Povidone Iodine Shelf Life Labeling

    Arrow International is recalling Arterial Access Trays because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.

    Product
    Arterial Access Tray, introducer catheter; Model: GU-04020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2018·2018-04-11

    Phadia Recalls ImmunoCAP Allergen c6 Amoxicilloyl Due to Stability Failures

    Phadia US Inc is recalling 950 units of ImmunoCAP Allergen c6, Amoxicilloyl because the product failed to meet stability specifications.

    Product
    ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1303-2018·2018-04-11

    Siemens Syngo.via Software Recall for Incorrect Report Data

    Siemens is recalling Syngo.via software because it fails to save corrected report values, potentially sending outdated information to physicians.

    Product
    Syngo.via. Medical Device Software. Picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1291-2018·2018-04-11

    Aesculap Recalls DS Titanium Ligation Clip Appliers for Labeling Updates

    Aesculap Implant Systems LLC is recalling 270 DS Titanium Ligation Clip Appliers to update instructions for use, adding contraindications for living donor nephrectomies.

    Product
    DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1285-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling 570 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1312-2018·2018-04-11

    Phadia Recalls ImmunoCAP Allergen c5 Ampicilloyl Test Kits

    Phadia US Inc is recalling ImmunoCAP Allergen c5, Ampicilloyl test kits because stability specifications were not met.

    Product
    ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1304-2018·2018-04-11

    Dynavox T10 Speech Generating Device Recalled for Battery Swelling

    Dynavox Systems LLC is recalling 4,615 T10 Speech Generating Devices because the internal battery may swell and cause the device case to separate.

    Product
    Dynavox T10 Speech Generating Device ( including Batteries)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1275-2018·2018-04-04

    Ray Station Software Recalled for Potential Incorrect Radiation Treatment Volume

    RaySearch Laboratories is recalling Ray Station 4.9 through 7 software due to a defect that may result in incorrect treatment volumes being delivered to patients.

    Product
    Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1253-2018·2018-04-04

    Stryker Recalls iVAS System Kits Due to Sterility Assurance Issues

    Stryker is recalling 51 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

    Product
    10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1249-2018·2018-04-04

    Stryker Spinal Orthopedic PCD Kit Recalled for Sterility Assurance Issues

    Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

    Product
    PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1262-2018·2018-04-04

    Allen Medical Systems Recalls F-T3SYSTEM Surgical Table Accessories

    Allen Medical Systems is recalling 83 F-T3SYSTEM surgical table accessories because rail section clamps may fail during use, posing a risk of critical harm to patients.

    Product
    F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1247-2018·2018-04-04

    Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns

    Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

    Product
    11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1260-2018·2018-04-04

    Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments

    Encore Medical is recalling 93 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.

    Product
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1244-2018·2018-04-04

    Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues

    Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.

    Product
    180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
    Category
    Medical Device
    Distribution
    1 state