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 27699

  • HighFDA (Devices)·Z-0140-2015·2014-11-05

    CP Medical Recalls Monoswift PGCL Sutures for Tensile Strength Failure

    CP Medical is recalling five lots of Monoswift PGCL absorbable surgical sutures because they failed to meet minimum tensile strength requirements over their shelf life.

    Product
    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0020-2015·2014-11-05

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications S.A. is recalling eight Proteus 235 Proton Therapy Systems due to a rare risk of exceeding prescribed radiation doses.

    Product
    Proteus 235 Proton Therapy System for cancer treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2015·2014-11-05

    SAM Medical Products Recalls Junctional Tourniquet Auxiliary Straps

    Sam Medical Products is recalling SJT 102 and 112 auxiliary straps because the snap hook broke during a training demonstration.

    Product
    SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2015·2014-11-05

    Maquet Cardiovascular Recalls Cardiac Surgery Systems Due to Tyvek Pouch Defects

    Maquet Cardiovascular is recalling specific cardiac surgery systems because internal findings identified pinholes or cuts in Tyvek pouches within the vacuum tubing sets.

    Product
    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2015·2014-11-05

    Coloplast Conveen Urine Collection Leg Bag Recalled for Seam Leakage

    Coloplast is recalling Conveen Urine Collection Leg Bags due to potential leakage from the bag seam when filled.

    Product
    Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2015·2014-11-05

    Medartis Recalls APTUS Ulna Shortening 2.5 Plates Due to Breakage

    Medartis, Inc. is recalling 44 APTUS Ulna Shortening 2.5 plates due to three complaints of temporary tension bolt breakage.

    Product
    APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0141-2015·2014-11-05

    Trumpf TITAN Operating Room Table Recalled for Unintended Movement

    Trumpf Medical Systems is recalling 184 TITAN Operating Room Tables due to unintended movement during surgery caused by damaged remotes.

    Product
    TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0008-2015·2014-10-29

    Respironics Esprit Ventilators Recalled for Power Supply Failure Risk

    Respironics is recalling Esprit V1000 and V200 ventilators because a power supply failure may cause loss of ventilator support, potentially leading to hypercarbia or hypoxemia.

    Product
    Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0086-2015·2014-10-29

    Siemens Mammomat Inspiration Mammography Systems Recalled for Safety Switch Defect

    Siemens is recalling three Mammomat Inspiration mammography systems because a safety switch defect may allow the needle positioning device to move during a biopsy.

    Product
    Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0089-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0091-2015·2014-10-29

    Codman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling Lumbar Drainage Catheter Kits because tubing may leak or disconnect, risking improper drainage or air entry.

    Product
    Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2015·2014-10-29

    Siemens Symbia E SPECT Systems Recalled for Loose Bolts in Detector Support

    Siemens Medical Solutions is recalling 562 Symbia E SPECT systems due to reports of loose bolts in the detector support structure.

    Product
    Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0098-2015·2014-10-29

    DeRoyal SafeLiner Suction Canister Kit Recalled for Insufficient Seal

    DeRoyal Industries is recalling 5,112 units of SafeLiner Suction Canister Kits due to an insufficient seal under low or intermittent suction conditions.

    Product
    DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0110-2015·2014-10-29

    Mortara Surveyor S12 and S19 Patient Monitors Recalled for Mounting Hazard

    Mortara Instrument is recalling 624 Surveyor S12 and S19 patient monitors due to a potential safety hazard when mounted with non-standard screws.

    Product
    Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2015·2014-10-29

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-Ds and TELIGENT ICDs due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2015·2014-10-29

    Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion

    Boston Scientific is recalling TELIGEN ICDs and COGNIS CRT-Ds due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2015·2014-10-29

    Siemens e.cam Gamma Camera Systems Recalled for Loose Bolts

    Siemens Medical Solutions is recalling e.cam gamma camera systems due to reports of loose bolts in the detector support structure.

    Product
    e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0090-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Tubing Leak Risk

    Codman & Shurtleff is recalling 93,558 EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2015·2014-10-29

    Zimmer Persona Tibial Articular Surface Inserter Recalled for Deformation Risk

    Zimmer, Inc. is recalling 618 units of the Persona Tibial Articular Surface Inserter because they did not undergo heat treatment, creating a risk of tip deformation.

    Product
    The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2015·2014-10-29

    DeRoyal and Novaplus Suction Canisters Recalled for Insufficient Seal

    DeRoyal Industries is recalling 13,900 non-sterile suction canisters and lids because they may have an insufficient seal under low or intermittent suction conditions.

    Product
    Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc Total reagents due to increased imprecision and positive bias that may cause false reactive results.

    Product
    Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Kit Recalled for Increased Imprecision

    Siemens is recalling ADVIA Centaur HBc Total kits due to increased imprecision and positive bias that may cause false reactive results.

    Product
    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2015·2014-10-29

    DePuy Synthes Radiolucent Retractor Recalled for Adhesive Tape Residue

    Synthes, Inc. is recalling 11 DePuy Synthes Radiolucent Retractors due to adhesive tape residue that poses a risk of tissue or systemic reactions.

    Product
    DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0113-2015·2014-10-29

    Vygon Recalls Bionector Needleless Connectors Due to Membrane Elasticity Issues

    Vygon is voluntarily recalling Bionector Needleless connectors due to potential problems with membrane elasticity. The recall affects 42,250 units distributed worldwide.

    Product
    Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
    Category
    Medical Device
    Distribution
    1 state