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.

37001–37025 of 50506

  • HighNHTSA·15V852000·2015-12-18

    Suzuki Recalls 2012-2014 Motorcycles Due to Engine Wear Risk

    Suzuki is recalling 6,214 motorcycles due to potential engine component wear that could cause a stall and increase crash risk.

    Product
    SUZUKI — SUZUKI SFV650, AN650, DL650
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V853000·2015-12-18

    Suzuki Recalls 2014-2015 DL1000 Motorcycles for Battery Ground Defect

    Suzuki is recalling 2,404 DL1000 motorcycles because a battery ground connection may corrode or attach to painted surfaces, causing engine stalling and increasing crash risk.

    Product
    SUZUKI — SUZUKI DL1000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16063·2015-12-17

    S.R. Smith Recalls Splash! and PAL Pool Lifts Due to Fall Hazard

    S.R. Smith is recalling Splash! and PAL pool lifts because welds can break, causing the lift to fall. Consumers should stop using the lifts and contact the company for a free replacement.

    Product
    Splash! and PAL pool lifts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0392-2016·2015-12-16

    Skipanon Brand Seafood Recalled for Lack of Documentation and Processing Concerns

    Skipanon Brand Seafoods LLC is recalling all cans and pouches of its seafood products due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED STEELHEAD***Ingredients: Farm-Raised Steelhead, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET WT. 5 1/2 oz. (156g)***" UPC: 58071 00142 Code beginning with "OC" Label has a…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk

    LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2016·2015-12-16

    Philips Brilliance 64 CT System Recalled for Software Defects

    Philips is recalling 1,765 Brilliance 64 CT systems worldwide due to software defects that may cause operational errors, image issues, or misdiagnosis.

    Product
    Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2016·2015-12-16

    Synthes Recalls Five TFN-Advanced Proximal Femoral Nailing Systems

    Synthes (USA) Products LLC is recalling five TFN-Advanced Proximal Femoral Nailing Systems because a design defect may prevent proper locking mechanism advancement or screw tightening.

    Product
    Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0384-2016·2015-12-16

    Skipanon Brand Canned Smoked Coho Salmon Recalled for Documentation Issues

    Skipanon Brand Seafoods LLC is recalling approximately 57,000 cans of smoked coho salmon due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Smoked Coho Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED COHO SALMON***Ingredients: Coho Salmon, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET wt. 5.5 oz. (156g)***" UPC: 58071 00113 Can code beginning with OCS. Product label has…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0387-2016·2015-12-16

    Skipanon Brand Canned Smoked Sockeye Salmon Recalled for Processing Concerns

    Skipanon Brand Seafoods LLC is recalling approximately 57,000 cans of smoked sockeye salmon due to lack of documentation and possible under-processing.

    Product
    Canned Smoked Sockeye Salmon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED SOCKEYE SALMON***Ingredients: Sockeye Salmon, Sea Salt, Brown Sugar, Natural Hardwood Smoke. NET wt. 5.5 oz. (170g)***" UPC: 58071 00140 Can code beginning with OCB. Label…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0385-2016·2015-12-16

    Skipanon Brand Canned Smoked Salmon Recalled for Under-Processing Risk

    Skipanon Brand Seafoods LLC is recalling approximately 57,000 cans of smoked Chinook salmon due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Smoked Chinook Salmon with paper label reading in part: "***SKIPANON BRAND SEAFOOD SMOKED CHINOOK SALMON***Ingredients: Salmon, Sea Salt, Brown Sugar Natural Hardwood Smoke. Net wt. 5 1/2 oz. (156g)***" UPC: 58071 00112 Can code beginning with OCC. Label has a…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0389-2016·2015-12-16

    Skipanon Brand Seafood Recalled for Possible Under-Processing

    Skipanon Brand Seafoods LLC is recalling all canned and pouch seafood products due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Peppered Smoked Steelhead with paper label reading in part: ***SKIPANON BRAND SEAFOOD Peppered SMOKED STEELHEAD***Ingredients: Farm-Raised Steelhead, Sea Salt, Brown Sugar, Cracked Peppercorns, Natural Hardwood Smoke. Net WT. 5 1/2 oz. (156g)***" UPC: 58071 00143…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·16059·2015-12-16

    Skip Hop Recalls Crib Mobiles Due to Injury Hazard

    Skip Hop is recalling Moonlight & Melodies projection crib mobiles because the strap attaching the product to the crib rail can break, posing an injury hazard if the product falls on an infant.

    Product
    Skip Hop crib mobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2016·2015-12-16

    Implant Direct Sybron Recalls DirectGuide Drill Extender for Dental Implants

    Implant Direct Sybron Manufacturing is recalling 26 lots of DirectGuide Drill Extenders because the drill may drop during use.

    Product
    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2016·2015-12-16

    Boston Scientific Recalls One Step Button PEG Kits Due to Adapter Defect

    Boston Scientific is voluntarily recalling specific lots of One Step Button PEG kits because a protrusion on the decompression tube adapter may prevent the device from being inserted or removed.

    Product
    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-0390-2016·2015-12-16

    Skipanon Brand Canned Smoked Sturgeon Recalled for Processing Concerns

    Skipanon Brand Seafoods LLC is recalling approximately 57,000 cans of smoked sturgeon due to lack of documentation and possible under-processing, which could lead to Clostridium botulinum contamination.

    Product
    Canned Smoked Sturgeon with paper label reading in part: ***SKIPANON BRAND SEAFOOD SMOKED STURGEON***INGREDIENTS: Sturgeon, Sea Salt, Brown Sugar Natural Hardwood Smoke. NET WT. 5.5 OZ. (156g)***" UPC: 58071 00111 Can code beginning with OCP. Label has a yellow…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0411-2016·2015-12-16

    Zimmer Persona EM Distal Rod Recalled for Ratchet Latching Defect

    Zimmer, Inc. is recalling 156 Persona EM Distal Rods because the ratchet teeth may not latch onto the rod. The defect could affect the stability of the surgical instrument during use.

    Product
    Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0380-2016·2015-12-16

    LeMaitre Over-the-Wire Embolectomy Catheter Recall for Packaging Defect

    LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise sterility.

    Product
    LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2016·2015-12-16

    Zimmer Persona EM Proximal Tube Recalled for Ratchet Latching Failure

    Zimmer, Inc. is recalling 156 Persona EM Proximal Tubes because the ratchet teeth may not latch onto the rod.

    Product
    Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System.
    Category
    Medical Device
    Distribution
    19 states