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.

31801–31825 of 50502

  • HighFDA (Devices)·Z-2680-2017·2017-07-19

    ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption

    ICU is recalling 7,848 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting patient therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2473-2017·2017-07-19

    Meduri Farms Recalls Dried Strawberries Due to Peanut Fragment

    Meduri Farms Inc is recalling specific lots of Dried Strawberries/Sugar Infused because a half peanut was found on the packaging line.

    Product
    Meduri Farms Dried Strawberries/Sugar Infused, Catalog # 010282. Dried Strawberries sugar infused packaged in a 10, 20 or 25 lbs. corrugated box or 10kg corrugated box with food grade plastic liner. The label is read in parts: "***INGREDIENTS: Strawberries, Sugar…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2572-2017·2017-07-19

    Schooner Pre-Cooked Crunchy Whiting Fillets Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Schooner Pre-Cooked Crunchy Whiting Fillets because the product may contain undeclared milk.

    Product
    SCHOONER PRE-COOKED CRUNCHY WHITING FILLETS 1/10 LB and SCHOONER PRE-COOKED CRUNCHY WHITING FILLETS 12/16 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2678-2017·2017-07-19

    ICU Recalls 214 Plum A+ Infusion Systems Due to Battery Error

    ICU is recalling 214 Plum A+ Infusion Systems because a battery issue can trigger an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2548-2017·2017-07-19

    Lil Fisherman Pollock Sticks Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Lil Fisherman Pre Cooked Pollock Sticks because the product may contain undeclared milk.

    Product
    LIL FISHERMAN PRE COOKED POLLOCK STICKS 1 OZ GRADE A 10 LB
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-2691-2017·2017-07-19

    St. Jude Medical Recalls Proclaim 5 Elite Implantable Pulse Generators

    St. Jude Medical is recalling 8,780 Proclaim 5 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2457-2017·2017-07-19

    Nutman Chocolate Peanuts Recalled for Undeclared Soy Allergen

    LJA Enterprises is recalling Nutman Chocolate Peanuts because the product failed to declare soy as an allergen. The product was distributed in Ohio.

    Product
    NUTMAN CHOCOLATE PEANUTS 5 oz (140 g) bags Ing: Peanuts, Sugar, Whole Milk, Liqueur, Coca Butter, Partially Hydrogenated Cocoa Powder, Choc, Salt, Lecithin (emulsifier) Vanilla (art flav..) MANUFACTURED IN A FIRM THAT ALSO PROCESSES PEANUTS Massillon, Ohio 44547 1-330-833-6660…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2707-2017·2017-07-19

    Merge Healthcare Recalls Schiller PB 1000 Patient Data Module

    Merge Healthcare is recalling 555 Schiller PB 1000 Patient Data Modules because the analog output may not accurately reflect the pressure waveform used for fractional flow reserve calculations.

    Product
    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2017·2017-07-19

    Natus Neurology Recalls Elite 2 MHz OB Probes Due to Excessive Noise

    Natus Neurology is recalling 2,335 Elite 2 MHz OB probes because excessive background noise may mask the user's ability to hear heart rate or blood flow.

    Product
    Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-2466-2017·2017-07-19

    3CS Organics Recalls Unapproved Holle Goat Milk Infant Formula

    3CS Organics LLC is recalling Holle goat milk infant formula products that are not FDA approved and lack English labeling.

    Product
    HOLLE Bio Lait Pour Nourrissons Au Lait De Chevre, Zuigelingenmelk OP Geitenmelbasis, 1, 400g (4/case), HOLLE Bio-Flogemilch Auf Ziegenmilchbasis, 1, 400g (4/case), HOLLE Bio-Folgenmilch Auf Ziegenmilchbasis, 3, 400g (4/case), HOLLE Bio-Folgemich, 2, 600g (3bx/case), HOLLE…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2722-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 900 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-2546-2017·2017-07-19

    Lil Fisherman Pollock Nuggets Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Lil Fisherman Pre Cooked Pollock Nuggets because they may contain undeclared milk.

    Product
    LIL FISHERMAN PRE COOKED POLLOCK NUGGETS 1 OZ PUFI 1/10 LB
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2551-2017·2017-07-19

    Matlaws Buffalo Popcorn Shrimp Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Matlaws Buffalo Popcorn Shrimp because the product may contain undeclared milk.

    Product
    MATLAWS P/C BRD BUFFALO POPCORN SHRIMP 12/8 OZ
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2570-2017·2017-07-19

    Schooner Pre-Cooked Cod Fillets Recalled for Undeclared Milk

    National Fish & Seafood, Inc. is recalling Schooner Pre-Cooked Crunchy Styled Cod Fillets because the product may contain undeclared milk.

    Product
    SCHOONER PRE-COOKED CRUNCHY STYLED COD FILLET 10 LB and SCHOONER PRE-COOKED CRUNCHY STYLED COD FILLETS 12/16 OZ
    Category
    Food
    Distribution
    24 states
  • HighNHTSA·17V459000·2017-07-19

    Carry-On Trailer Recalls 2017 Models Due to Electric Brake Defect

    Carry-On Trailer is recalling 2017 Utility, Dump, and Enclosed trailers because a faulty breakaway box light may cause the circuit board to fail, increasing crash risk.

    Product
    CARRY-ON TRAILER — CARRY-ON TRAILER ENCLOSED, UTILITY, DUMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2716-2017·2017-07-19

    ICU Medical Recalls 18 cm Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 304 units of 18 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may leak.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2732-2017·2017-07-19

    Nova Biomedical Stat Profile Prime Analyzer Software Recall

    Nova Biomedical is recalling Stat Profile Prime Analyzers because a software defect could cause scheduled quality control tests to overwrite pending patient results.

    Product
    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2017·2017-07-19

    St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators

    St. Jude Medical is recalling 443 Infinity 5 Implantable Pulse Generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2574-2017·2017-07-19

    Recall of 365 Everyday Value Precooked Breaded Fish Squares for Undeclared Milk

    National Fish & Seafood, Inc. is recalling 365 Everyday Value Precooked Breaded Fish Squares because the product may contain undeclared milk.

    Product
    365 EVERYDAY VALUE ALL NATURAL PRECOOKED BREADED FISH SQUARES 10/2 LBS NET WT. 20 LBS (9.07 kg)
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2537-2017·2017-07-19

    Morris J. Golombeck Recalls Birds Eye Chilies for Potential Peanut Contamination

    Morris J. Golombeck, Inc. is recalling 8,000 lbs of Birds Eye Chilies due to potential peanut contamination. The product was distributed across multiple US states and Canada.

    Product
    BIRDS EYE CHILIES MJG # 8178, Polybags Net wt. 25 Kg (50-55 Lbs.) Imported from Madagascar
    Category
    Food
    Distribution
    8 states