The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

44076–44100 of 50511

  • HighFDA (Devices)·Z-0794-2013·2013-02-13

    Allergen Medical Recalls SeriScaffold Surgical Scaffold Due to Sterility Concerns

    Allergen Medical is recalling SeriScaffold Surgical Scaffold units because the outer packaging seal may be compromised, potentially compromising sterility.

    Product
    SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0978-2013·2013-02-13

    Penzeys Vietnamese Cinnamon Recalled Due to Glass Contamination

    Penzeys is recalling Vietnamese Cinnamon Extra Fancy after a customer reported finding pieces of glass in the product.

    Product
    Vietnamese Cinnamon Extra Fancy, product code 43200, Penzeys Spices, Wauwatosa, WI 53222. to be completed
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0775-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells with Porosity Defects

    Zimmer, Inc. is recalling Trilogy Acetabular Shells with holes because some units have porosity below the specified range, which may affect bone ingrowth.

    Product
    Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2013·2013-02-13

    Synthes Spine Drill Bit Recalled for Potential Drill Stop Slippage

    Synthes USA is recalling 63 units of 2.5mm drill bits for the Vectra Spine System due to a potential drill stop slippage hazard.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2013·2013-02-13

    Synthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk

    Synthes USA is recalling 48 units of the Spine Vectra Adjustable Drill Stop because the device may slip on the drill bit, posing a risk of adverse events during surgery.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0766-2013·2013-02-13

    Tobii P10 Battery Box Recalled for Smoke and Chemical Smell During Recharging

    Tobii Assistive Technology is recalling 483 P10 battery boxes that malfunctioned while recharging, producing smoke and a chemical smell.

    Product
    P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0982-2013·2013-02-13

    Tristar Food Wholesale Recalls Dried Cabbage for Undeclared Sulfites

    Tristar Food Wholesale is recalling Double Swallow brand dried cabbage because it contains undeclared sulfites, a preservative that poses a risk to sensitive individuals.

    Product
    Outer Cardboard Container - China Products Fresh Dried Cabbage. Plastic Bag: Double Swallow Brand, Net Wt 0.15 Kg (529 OZ), Dehydrated Cole, Jiangmen Native Produce Import & Export Company of Guangdong China.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0774-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects

    Zimmer, Inc. is recalling Trilogy Acetabular AB Shells because some units have porosity levels below the required specification.

    Product
    Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2013·2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling 80 breast biopsy trays because they may contain particulate matter in the pharmaceuticals used for injection.

    Product
    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2013·2013-02-13

    Winco Cozy Comfort Premier Recliner 5580 Recalled for Fire Safety Non-Compliance

    Winco Mfg. is recalling 95 Cozy Comfort Premier Recliner 5580 units because the foam and vinyl chemicals do not consistently meet California TB 133 fire protection mandates.

    Product
    Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2013·2013-02-13

    Anspach Effort Recalls Bearing Sleeve Devices Due to Metal Fragment Risk

    The Anspach Effort, Inc. is recalling 8 MA-15C Bearing Sleeve devices distributed in Massachusetts. The recall addresses a risk of metal fragments remaining in the surgical site.

    Product
    Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0791-2013·2013-02-13

    Medacta Quadra Trial Broach size 0 recalled due to tip breakage

    Medacta USA Inc. is recalling 26 units of the Quadra Trial Broach size 0 because the tip broke during surgery.

    Product
    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2013·2013-02-13

    Lansinoh Thera Pearl Breast Therapy Hot and Cold Packs Recalled for Overheating Risk

    Lansinoh is recalling Thera Pearl 3-in-1 Breast Therapy packs because incorrect Spanish heating instructions may cause the product to overheat.

    Product
    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units have porosity below the specified range.

    Product
    Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2013·2013-02-13

    Invacare Solara 3G Manual Wheelchair Recalled for Brake Failure Risk

    Invacare is recalling three Solara 3G custom manual wheelchairs because the wheels may rotate freely despite the hub brake being engaged.

    Product
    Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0768-2013·2013-02-13

    Oxus Portable Oxygen Concentrator Li-Ion Battery Recall

    Oxus America is recalling 1,724 Li-Ion batteries for the RS-00400 Portable Oxygen Concentrator due to potential over-discharge damage to cells.

    Product
    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
    Category
    Medical Device
    Distribution
    16 states
  • HighCPSC·13724·2013-02-12

    Bohning Recalls Middleton Siege Crossbows Due to Unexpected Firing Hazard

    Bohning is recalling Middleton Siege Crossbows because they can fire unexpectedly or have limbs that crack. Consumers should stop using them and contact Bohning for a refund.

    Product
    Middleton Siege Crossbows
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13C001000·2013-02-12

    Recaro Recalls ProSport Child Seats Due to Head Movement Risk

    Recaro is recalling ProSport model 385 child seats because excessive head movement can occur when installed with LATCH anchors only, increasing injury risk.

    Product
    CHILD SEAT:TETHER: CONNECTOR/CLIP recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13E007000·2013-02-08

    Fulmer Motorcycle Helmets Recalled for Safety Standard Non-Compliance

    Fulmer is recalling specific motorcycle helmet models that fail to meet federal safety standards for impact and retention. Owners should contact the manufacturer for a replacement or reimbursement.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13118·2013-02-07

    Mutsy USA Recalls EVO Strollers Due to Strangulation Hazard

    Mutsy USA is recalling EVO strollers because an opening between the grab bar and seat can allow an infant's body to pass through, posing a strangulation hazard.

    Product
    EVO strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V044000·2013-02-07

    BMW Recalls 516,791 Vehicles for Battery Cable Connector Defect

    BMW is recalling 516,791 vehicles from 2007-2012 because a battery cable connector may degrade, causing loss of electrical power and unexpected stalling.

    Product
    BMW — BMW 328I, 335I, 128I, 135I
    Category
    Vehicle
    Distribution
    Distributed nationwide