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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31626–31650 of 40325

  • HighFDA (Devices)·Z-0163-2016·2015-11-04

    Abbott Recalls ARCHITECT i2000SR Systems Due to Incorrect Tubing

    Abbott Laboratories is recalling 65 ARCHITECT i2000SR diagnostic systems worldwide because they contain incorrect tubing.

    Product
    ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2016·2015-11-04

    Encore Medical Recalls Reverse Shoulder Prosthesis Stem Impaction Fixtures

    Encore Medical is recalling 634 units of Reverse Shoulder Prosthesis Stem Impaction Fixtures because polymer wear from the fixtures can damage the titanium coating on humeral stems during assembly.

    Product
    Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0182-2016·2015-11-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Hardware Defects

    Siemens is recalling 2,099 ACUSON SC2000 ultrasound systems due to hardware defects involving wheel lock disconnection and system lockups.

    Product
    ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0192-2016·2015-11-04

    Synthes Threaded Plate Holder Recalled for Incorrect Part Number Etching

    Synthes (USA) Products LLC is recalling 25 units of Threaded Plate Holders that are incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

    Product
    Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2016·2015-11-04

    Philips Ingenuity Core 128 CT Systems Recalled for X-ray Measurement Error

    Philips Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.

    Product
    Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0167-2016·2015-11-04

    Synthes 2.7 mm Locking Screws Recalled for Mislabeling as 2.4 mm

    Synthes (USA) Products LLC is recalling 98 units of 2.7 mm locking screws that were mislabeled as 2.4 mm. The units were distributed to Tennessee.

    Product
    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0164-2016·2015-11-04

    Sentinel Ammonia Reagent Recalled for Inaccurate Results in Heparin Tubes

    Sentinel CH SpA is recalling 765 kits of Sentinel MULTIGENT Ammonia Ultra Reagent because results may be below the linear range for samples collected in heparin tubes.

    Product
    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0174-2016·2015-11-04

    Philips Recalls Brilliance 64 CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 108 Brilliance 64 CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts.

    Product
    Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0175-2016·2015-11-04

    Philips Ingenuity Core CT Systems Recalled for X-ray Measurement Error

    Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2016·2015-11-04

    Philips Recalls Brilliance 16-Slice CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 323 Brilliance 16-Slice CT systems worldwide due to X-ray measurement errors causing Ring/Dot artifacts.

    Product
    Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0170-2016·2015-11-04

    Varian ARIA Radiation Oncology Software Recall for Printing Anomaly

    Varian Medical Systems is recalling ARIA Radiation Oncology software versions 10, 11, 13.0, and 13.5 because admin instructions may fail to print or transmit.

    Product
    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0178-2016·2015-11-04

    Philips Recalls Ingenuity Flex CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 67 Ingenuity Flex CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2016·2015-11-04

    Nipro Safe Touch TULIP Safety Fistula Needle Packaging Error Recall

    Nipro Medical Corporation is recalling 50,000 fistula needles because some 1 1/4-inch needles were packaged in 1-inch blister packs.

    Product
    Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0172-2016·2015-11-04

    Spacelabs CardioCall ECG Event Recorders Recalled for Battery Defect

    Spacelabs Healthcare is recalling CardioCall ECG Event Recorders because a battery defect causes continuous ringing and prevents normal operation.

    Product
    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0165-2016·2015-11-04

    Encore Medical Recalls Exprt Precision System Knee Implants for Missing Labeling

    Encore Medical is recalling 209 Exprt Precision System Revision Knee implants because the labeling is missing size and diameter information.

    Product
    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Devices)·Z-0171-2016·2015-11-04

    BD CD3 FITC Recalled for Spanish Labeling Error

    Becton, Dickinson and Company is recalling two lots of BD CD3 (SK7) FITC in vitro diagnostic reagents due to an error in the Spanish small text on the label.

    Product
    BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2016·2015-10-28

    Elekta XiO Radiation Treatment Planning System Recalled for Incorrect Treatment Delivery

    Elekta is recalling 1,440 XiO Radiation Treatment Planning Systems because they may deliver incorrect treatments when using third-party fixed wedges.

    Product
    XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0158-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 1,246 units of the MOSAICPLASTY DP Disposable Harvesting System because a packaging breach compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2016·2015-10-28

    ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue

    ConForMIS is recalling iDuo Bicompartmental Knee Replacement Systems due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 603 units of the MOSAICPLASTY DP Disposable Harvesting System because a breach in the packaging compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2016·2015-10-28

    ConFormis iDUO G2 Knee Implant Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling one unit of the ConFormis iDUO G2 knee implant due to potential ethylene glycol residue.

    Product
    ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2016·2015-10-28

    ConForMIS iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 313 units of the iTotal CR Knee Replacement System due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2016·2015-10-28

    Baxter Recalls Microbore Catheter Extension Sets Due to Potential Leak

    Baxter Healthcare Corp is recalling 23,600 units of One-Link Microbore Catheter Extension Sets due to a potential leak at the tubing to luer bond.

    Product
    ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0141-2016·2015-10-28

    ConForMIS iUni Knee Replacement Recalled for Ethylene Glycol Residue

    ConForMIS is recalling 68 iUni Unicondylar Knee Replacement Systems due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2016·2015-10-28

    ConForMIS iUni Knee Replacement System Recalled for Ethylene Glycol Residue

    ConForMIS is recalling 7 units of the iUni Unicondylar Knee Replacement System due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide