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.

45176–45200 of 50512

  • HighFDA (Devices)·Z-2202-2012·2012-08-22

    Carestream DRX-1 System Battery Recall for Overheating Risk

    Carestream Health is recalling DRX-1 system batteries manufactured before June 2012 due to two reported instances of lithium-ion battery overheating that may cause burns.

    Product
    Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1328-2012·2012-08-22

    FunFresh Foods Recalls Organic Cacao Nibs Due to E. coli Contamination

    FunFresh Foods Inc is recalling 500 units of World Berry Organic Cacao Nibs 6 oz due to E. coli contamination. The product was distributed to health and natural food stores in 30 states.

    Product
    FunFresh Foods World Berry Organic Cacao Nibs 6 oz, packaged in blue, brown, red, white, black and green packaging with red, black, yellow, white, and green print writing. The packaging is resealable.
    Category
    Food
    Distribution
    29 states
  • HighFDA (Devices)·Z-2215-2012·2012-08-22

    Zimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors Due to Fractures

    Zimmer, Inc. is recalling specific Trabecular Metal Reverse Shoulder Liner Impactors due to reports of alignment peg fractures. The recall affects units manufactured from 455 stainless steel.

    Product
    00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·12253·2012-08-22

    Energizer Recalls Rotating Night Lights Due to Burn Hazard

    Energizer is recalling rotating night lights sold at Target because they can overheat and smoke, posing a burn hazard. No injuries have been reported.

    Product
    Energizer Rotating Night Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1935-2012·2012-08-22

    Icrest International Recalls Oyster Meat Due to Insanitary Conditions

    Icrest International LLC is recalling Oyster Meat IQF Large 5/4 Lbs due to preparation under insanitary conditions that may have contaminated the product.

    Product
    OYSTER MEAT IQF LARGE 5/4 LBS PRODUCT OF KOREA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2012·2012-08-22

    Maquet Pediatric Arterial Cannula Recall for Limited Flexibility

    Maquet Inc. is recalling certain pediatric arterial cannulas because the hardened tip may be too long, limiting flexibility during extracorporeal circulation procedures.

    Product
    Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2188-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2012·2012-08-22

    Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues

    Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.

    Product
    Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·12V410000·2012-08-21

    Kaufman Flatbed Trailers Recalled for Oil Bath Axle Leak Risk

    Kaufman is recalling 2011 flatbed trailers because oil bath axle caps may leak, potentially causing wheel bearing failure and increasing crash risk.

    Product
    KAUFMAN — KAUFMAN FLATBED
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12E030000·2012-08-20

    BESI Recalls Pro-Tech III Child Securement Systems for School Buses

    BESI is recalling Pro-Tech III child securement systems for school buses because one buckle can be pulled out with minimal pressure, potentially failing to restrain occupants in a crash.

    Product
    SEAT BELTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V408000·2012-08-20

    GM Recalls 2012 Chevrolet Sonic for Windshield Washer Hose Defect

    General Motors is recalling 2012 Chevrolet Sonic vehicles because the windshield washer hose may separate, preventing washer fluid from reaching the windshield and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12249·2012-08-16

    Emerson Corsair Ceiling Fans Recalled Due to Falling Hazard

    Emerson is recalling Corsair ceiling fans because the hanger bracket can spread apart, causing the fan to fall from the ceiling.

    Product
    Emerson Corsair Ceiling Fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·12248·2012-08-16

    Gerber Bear Grylls Parang Machetes Recalled for Laceration Hazard

    Gerber is recalling Bear Grylls Parang Machetes because a weakness in the handle-blade connection can cause breakage, posing a laceration risk.

    Product
    Gerber® Bear Grylls Parang Machetes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·12744·2012-08-16

    PBteen Recalls Beadboard Bunk Beds Due to Risk of Injury

    PBteen is recalling Beadboard Bunk Beds because the front upper horizontal panel can crack or break, posing a risk of injury.

    Product
    Beadboard Bunk Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·12250·2012-08-16

    Babylicious Recalls Cloth Crib Fringes Due to Strangulation Hazard

    Babylicious is recalling cloth crib fringes because the narrow fabric strip presents a strangulation hazard to young children. Consumers should remove the product and contact the company for a refund.

    Product
    Babylicious Cloth Crib Fringes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2012·2012-08-15

    Medical Specialties Distributors Recalls Leaking Medstream Infusion Sets

    Medical Specialties Distributors is recalling Medstream 81-inch infusion sets that may leak at the Y-site. The recall covers 472 cases distributed nationwide.

    Product
    Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2012·2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Potential Breakage

    Smith & Nephew is recalling 2,204 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Part Number: 72202896 Product Usage: intended for use for the reattachment of soft tissue to bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1574-2012·2012-08-15

    River Ranch Recalls Sysco Spring Mix Due to Listeria Risk

    River Ranch Fresh Foods is recalling Sysco brand Spring Mix because samples tested positive for Listeria monocytogenes.

    Product
    Sysco brand Spring Mix, 48 oz bag, UPC: n/a; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2138-2012·2012-08-15

    Tango3 Water Storage Tank Recalled for Quality System Deficiencies

    Tango3 LLC is recalling 44 water storage tanks with ozone disinfection systems due to quality system deficiencies and lack of assurance that systems operate at minimum ozone levels.

    Product
    TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water…
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-2149-2012·2012-08-15

    Apheresis Technologies Recalls Plasma Pump Model PP-04a Due to Rotor Failure

    Apheresis Technologies is recalling 13 Plasma Pump Model PP-04a units because a rotor stopped during treatment, interrupting flow.

    Product
    Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2153-2012·2012-08-15

    Varian ARIA Oncology Software Recall Due to Incorrect MLC Data Import

    Varian Medical Systems is recalling two units of ARIA Oncology Information System software due to a defect that incorrectly imports MLC leaf positions for specific treatment plans.

    Product
    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide