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.

40626–40650 of 50511

  • HighFDA (Devices)·Z-2252-2014·2014-08-27

    Philips IntelliSpace PACS 4.4 Software Recall for Data Integrity Issues

    Philips is recalling IntelliSpace PACS 4.4 software because a defect may cause incomplete patient data to be exported, potentially affecting diagnosis.

    Product
    Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2293-2014·2014-08-27

    ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues

    ICU Medical is recalling CAP Change Kits with MicroClave Clear because some packages may have open seals, potentially compromising sterility.

    Product
    CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2014·2014-08-27

    Synthes 3.0 MM TI Cannulated Screw Set Recalled for Cytotoxicity Risk

    Synthes, Inc. is recalling 3.0 MM TI Cannulated Screw Instrument and Implant Sets that were exposed to flood water and reprocessed. Testing indicated the components may be cytotoxic.

    Product
    Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2290-2014·2014-08-27

    Pentax Endoscope Gas/Water Valve Recall Due to Instructions for Use Risk

    Pentax Medical Company is recalling OF-B130 and OF-B194 Gas/Water Feeding Valves because failure to follow the Instructions for Use may cause a potential risk to health.

    Product
    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2298-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.

    Product
    Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2348-2014·2014-08-27

    Fish Family Farm and Shadow Valley Farm Milk Recalled for Peanut Contamination

    Fish Family Farm is recalling Grade A Whole Milk due to potential contamination with peanuts and pistachios. The products were sold in Connecticut and Massachusetts.

    Product
    FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A WHOLE MILK Pasteurized and Homogenized in a glass half-gallon container
    Category
    Food
    Distribution
    2 states
  • HighCPSC·14264·2014-08-27

    NRS Recalls Water Sports Helmets Due to Chin Strap Rivet Failure Risk

    NRS is recalling about 3,300 water sports helmets because rivets holding the chin strap can fail, posing a risk of head injury. No injuries have been reported.

    Product
    NRS water sports helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2014·2014-08-27

    Invivo Recalls Philips IP5 MRI Patient Monitoring Devices

    Invivo Corporation is recalling 573 Philips IP5 Information Portal devices because a wireless function defect could interrupt communication with the host monitoring system.

    Product
    Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Screws for Leak Test Failures

    Zimmer, Inc. is recalling 6.5 mm Cancellous Screws that failed leak tests due to inner cavity damage. The recall covers 47,682 units distributed nationally and internationally.

    Product
    6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2301-2014·2014-08-27

    Zimmer Recalls Persona Knee System Trial Components Due to Breakage

    Zimmer, Inc. is recalling Persona Knee System trial components after receiving complaints about breakage. The recall covers distribution events in the US and several international countries.

    Product
    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2345-2014·2014-08-27

    Fish Family Farm Chocolate Milk Recalled for Peanut and Tree Nut Contamination

    Fish Family Farm is recalling 92 half-gallons of Shadow Valley Farm brand chocolate milk due to potential contamination with peanuts and pistachios.

    Product
    FISH FAMILY FARM INC. & & Shadow Valley Farm brand CHOCOLATE MILK GRADE A PASTEURIZED HOMOGENIZED in a glass half-gallon container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2340-2014·2014-08-27

    Renfro Foods Recalls XOCHITL Chipotle Queso Dip Due to Undeclared Wheat

    Renfro Foods is recalling XOCHITL Chipotle Queso Dip because a supplier mistakenly used wheat instead of whey in the cheese pre-mix, creating an undeclared allergen hazard.

    Product
    XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; HOT; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2347-2014·2014-08-27

    Fish Family Farm Skim Milk Recalled for Peanut and Tree Nut Contamination

    Fish Family Farm is recalling Grade A Fat Free Skim Milk due to potential contamination with peanuts and pistachios.

    Product
    FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A FAT FREE SKIM MILK Pasteurized and Homogenized in a glass half-gallon container
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2299-2014·2014-08-27

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals

    Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reported breakage. The recall covers corrective actions taken earlier this year.

    Product
    Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2014·2014-08-27

    Ortho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches

    Ortho Development is recalling various knee implant components because improperly sealed foil pouches allow air to enter, increasing the risk of material degradation due to oxidation.

    Product
    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V515000·2014-08-26

    Jayco Recalls 2015 Seismic Fifth Wheels for Incorrect Cargo Labels

    Jayco is recalling 2015 Seismic fifth wheel trailers because incorrect cargo capacity labels may lead to overloading, tire failure, and crashes.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL SEISMIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14746·2014-08-26

    Cree Recalls LED High-Bay Luminaires Due to Laceration Hazard

    Cree is recalling approximately 10,000 LED high-bay luminaires because the tempered glass lens can break, posing a laceration hazard. No injuries have been reported.

    Product
    LED High-Bay Luminaires
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14745·2014-08-21

    StoveTop FireStop Microhood Recalled Due to Fire Suppression Failure Risk

    WilliamsRDM is recalling StoveTop FireStop Microhood units because the front canister may fall off and fail to suppress fires. No injuries have been reported.

    Product
    The StoveTop FireStop® Microhood™ Fire Suppressors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14260·2014-08-21

    SolarWorld Recalls Solar Systems with Copper Grounding Lugs

    SolarWorld is recalling solar systems installed with bare-copper grounding lugs due to corrosion risks that could cause electric shock, electrocution, or fire.

    Product
    SolarWorld Solar Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2014·2014-08-20

    Gambro Recalls Prisma M 60 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 60 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2226-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recall for Malfunction Risk

    Medical Positioning Inc is recalling 20 Rapid Response HUT tables because a defective component may cause the table to drop into the Trendelenburg position too rapidly.

    Product
    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide