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.

35276–35300 of 50504

  • HighFDA (Devices)·Z-2073-2016·2016-07-06

    Pentax Laryngo Stroboscope Recalled Due to Lodged Accessories Risk

    Pentax Medical Company is recalling 206 Laryngo Stroboscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2062-2016·2016-07-06

    Hospira Recalls LifeShield IV Sets Due to Potential Fluid Leakage

    Hospira is recalling approximately 3.9 million LifeShield IV administration sets because fluid may leak at the secondary port.

    Product
    *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: List No. 19685-28…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16209·2016-07-06

    Yuka Clothing Recalls Self-Balancing Scooters Due to Fire Hazard

    Yuka Clothing is recalling about 800 self-balancing scooters sold nationwide and online because the lithium-ion battery packs can overheat, posing a risk of smoking, fire, or explosion.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2016·2016-07-06

    Pentax Medical Recalls Bronchoscopes Due to Lodged Accessories

    Pentax Medical is recalling 4,195 bronchoscopes because operational and cleaning accessories can become lodged in the instrument channel.

    Product
    Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2072-2016·2016-07-06

    Pentax Intubation Scope Recall Due to Lodged Accessories in Instrument Channel

    Pentax Medical Company is recalling 1,220 intubation scopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea.…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2108-2016·2016-07-06

    Beckman Coulter Recalls Access Free T3 Assay Kits Due to Result Shifts

    Beckman Coulter is recalling Access Free T3 Assay kits because they may show an upward shift in patient results. The recall covers 205,744 kits distributed worldwide.

    Product
    Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2054-2016·2016-07-06

    Nephron Recalls Sodium Chloride Inhalation Solution Due to Sterility Concerns

    Nephron Pharmaceuticals is recalling 13,692 cartons of Sodium Chloride Inhalation Solution due to a failure in the internal dye ingress test, which raises concerns about the sterility of the vials.

    Product
    Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For…
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Drugs)·D-1055-2016·2016-07-06

    Vital Care Compounder Recalls Brilliant Blue G Injection Vials

    Vital Care Compounder is recalling 9 vials of Brilliant Blue G injection due to a defect in the aluminum crimps that may compromise sterility.

    Product
    Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1054-2016·2016-07-06

    Vital Care Compounder Recalls Methylcobalamin Vials Due to Sterility Concerns

    Vital Care Compounder is recalling 39 vials of Methylcobalamin 5,000 mcg/ml because aluminum crimps may not fully seal the rubber stoppers, compromising sterility.

    Product
    Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2067-2016·2016-07-06

    Pentax Choledochoscope Recall Due to Potential Instrument Channel Lodging

    Pentax Medical is recalling 50 units of FCP-8P and FCP-9P choledochoscopes because accessories and therapeutic devices may become lodged in the instrument channel.

    Product
    Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1596-2016·2016-07-06

    Riba Foods Recalls Bayou Brothers Creole Sauce for Undeclared Fish

    Riba Foods Inc is recalling Bayou Brothers Creole Sauce because it contains undeclared fish. The product was distributed in Texas.

    Product
    Bayou Brothers Creole Sauce NET WT 33OZ. (2 LBS 1 OZ) 936g packaged in a glass jar
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2079-2016·2016-07-06

    Pentax Medical Recalls Esophagoscopes Due to Lodged Accessories Risk

    Pentax Medical is recalling 405 esophagoscopes because operational accessories can become lodged in the instrument channel.

    Product
    Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2070-2016·2016-07-06

    Pentax Cystoscopes Recalled Due to Risk of Lodged Accessories in Instrument Channel

    Pentax Medical Company is recalling 120 cystoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2049-2016·2016-07-06

    Baxter Recalls PrismaSate Dialysis Solution Bags Due to Leaks

    Baxter Healthcare is recalling 10,054 units of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy because of leaks near the top of the bags.

    Product
    PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
    Category
    Medical Device
    Distribution
    32 states
  • HighCPSC·16756·2016-07-06

    Little Lotus Baby Swaddles and Sleeping Bags Recalled for Choking Hazard

    Embrace Technologies is recalling Little Lotus baby swaddles and sleeping bags because shoulder snaps can break or detach, posing a choking hazard to young children.

    Product
    Little Lotus baby swaddles and sleeping bags
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2016·2016-07-06

    Siemens Hettich Centrifuge Modules Recalled for Premature Bucket Failures

    Siemens Healthcare Diagnostics Inc. is recalling 487 Hettich Centrifuge Modules due to premature bucket failures. The units were distributed nationwide.

    Product
    Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2016·2016-07-06

    Medical Depot Recalls Aluminum Crutches Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of Universal Quick Adjust aluminum crutches because the metal tips may fail.

    Product
    Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2016·2016-07-06

    Medical Depot Universal Aluminum Crutches Recalled for Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of Universal aluminum crutches because the bottom metal tips may fail.

    Product
    Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2016·2016-07-06

    Pentax Small Bowel Scope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling 96 Small Bowel Scopes because operational and cleaning accessories can become lodged in the instrument channel.

    Product
    Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2102-2016·2016-07-06

    Medical Depot Recalls EZ Adjust Aluminum Crutches Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of EZ adjust aluminum crutches because the tip may fail, posing a risk of injury.

    Product
    EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V510000·2016-07-06

    MCI Recalls 2015-2016 J4500 Buses Due to Window Hardware Defect

    Motor Coach Industries is recalling 2015-2016 J4500 buses because improperly installed window hardware may allow windows to open unexpectedly, increasing ejection risk.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2016·2016-07-06

    Hospira Recalls LifeShield IV Administration Sets Due to Fluid Leakage

    Hospira is recalling specific LifeShield IV administration sets because intravenous fluid may leak at the CLAVE secondary port.

    Product
    *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2016·2016-07-06

    Philips CT Scanner Recall Due to Potential Cover Cracking Hazard

    Philips is recalling three Brilliance CT Big Bore Oncology scanners because a thinner plastic cover may crack and cause injury to patients or staff.

    Product
    Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2068-2016·2016-07-06

    Pentax Medical Recalls Colonoscopes Due to Lodged Accessories

    Pentax Medical is recalling 12,412 colonoscopes because operational and cleaning accessories can become lodged in the instrument channel.

    Product
    Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when…
    Category
    Medical Device
    Distribution
    2 states