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.

35401–35425 of 50504

  • HighFDA (Devices)·Z-1985-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology

    Navilyst Medical is recalling 445 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2016·2016-06-22

    CarboFix Recalls Piccolo Composite Tibia and Femoral Nailing System Guide Wires

    CarboFix Orthopedics is recalling 638 Piccolo Composite Ball Tip Guide Wires because the internal package was compromised, potentially affecting sterility.

    Product
    Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1472-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Cookie Dough for Undeclared Peanut

    CSM Bakery Products is recalling frozen pre-cut cookie dough because it contains undeclared peanut protein. Consumers should not eat the product.

    Product
    Chocolate Chip, TranSmart, Frozen Pre-cut Cookie Dough, Net Weight 22.5 lbs (10.22 kgs).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1952-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch sterile barrier system.

    Product
    TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - 00588605410 TM LPS TIB SZ 4 C/D, 12MM - 00588605412 TM LPS TIB SZ 4 C/D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2016·2016-06-22

    Med Tec Recalls Protura Robotic Couch System Software Due to Positioning Issues

    Med Tec Inc is recalling specific versions of Protura Robotic Couch System Software because non-sub-millimeter positioning is inconsistent with settings in split shift mode.

    Product
    Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1490-2016·2016-06-22

    Frosty Acres Fry Oil Recalled for Foreign Material Contamination

    Oasis Trading Co. is recalling 180 containers of Frosty Acres fry oil because the bottles contained high density polyethylene resin trim rings.

    Product
    Frosty Acres Restaurant's Pride Advantage Clear Fry Oil, Net Wt. 35 LB (15.88), Packed for F.A.B. Inc., General Offices: Alpharetta, GA 30005, UPC 0 4820054764 2
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1963-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate Presence

    Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1955-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns

    Zimmer Biomet is recalling specific lots of Trabecular Metal implants manufactured between April 2011 and October 2012 due to concerns about the sterile integrity of the foil pouches.

    Product
    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1444-2016·2016-06-22

    CSM Bakery Recalls 7 Eleven Chocolate Chunk Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling 7 Eleven Chocolate Chunk Cookies because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    7 Eleven, Chocolate Chunk Cookie (2.2 oz Pucks), Net Weight 33 lb (14.96 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1471-2016·2016-06-22

    CSM Bakery Products Recalls Chocolate Chip Cookie Dough for Undeclared Peanut

    CSM Bakery Products is recalling specific batches of TranSmart Chocolate Chip Cookie Dough because the product contains undeclared peanut protein.

    Product
    1.25 oz. TranSmart, Chocolate Chip Cookie Dough, Net Weight: 23.44 lbs. (10.63 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1966-2016·2016-06-22

    Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1507-2016·2016-06-22

    Silver Source Canola Salad Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling 540 containers of Silver Source Canola Salad Oil due to the presence of high density polyethylene resin trim rings in the bottles.

    Product
    Silver Source Canola Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795427707
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1946-2016·2016-06-22

    Cordis PRECISE PRO RX Nitinol Stent System Recalled for Deployment Failure

    Cordis Corporation is recalling PRECISE PRO RX Nitinol Stent Systems (Carotid) due to a risk of inability to deploy or partial deployment.

    Product
    Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1463-2016·2016-06-22

    CSM Bakery Products Recalls TranSmart Sugar Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling TranSmart Sugar Cookie Dough because it contains undeclared peanut protein. Consumers should check their pantries for the specific batch numbers listed.

    Product
    TranSmart, Sugar Cookie Dough, 576/0.75 ounce cookies, Net Weight 27 lbs/12.26 kgs and 96/4 ounce cookies, Net Weight 24 lbs/10.9 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1958-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate

    Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate.

    Product
    BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1527-2016·2016-06-22

    Spice Chain Recalls Rose Red Organic Ginger Products Due to Salmonella

    Spice Chain is recalling Rose Red Organic Ginger products after a positive Salmonella test. The recall covers 5,240 pounds distributed in New Jersey and South Carolina.

    Product
    Rose Red Organic Ginger Steam Filter Bag & Organic Ground Ginger Steam packaged in a poly-lined corrugated carton; 40 lb case bulk pack 40 lbs
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1457-2016·2016-06-22

    CSM Bakery Products Recalls Macadamia Nut Cookies for Undeclared Peanut

    CSM Bakery Products is recalling TranSmart White Chunk Macadamia Nut cookies due to undeclared peanut protein. The recall covers 34,525 cases distributed across 19 states and Colombia.

    Product
    TranSmart White Chunk Macadamia Nut, 168 2.5 oz. Cookies, Net Weight: 26.25 lbs 11.91 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1494-2016·2016-06-22

    Oasis Foods Canola Oil Recalled for Foreign Material Contamination

    Oasis Foods is recalling 35 lb bottles of Canola Oil because they were reported to contain a high density polyethylene resin trim ring.

    Product
    Oasis Foods Canola Oil, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10841 7
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1473-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Pre-cut Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling specific lots of frozen pre-cut chocolate chip cookie dough due to undeclared peanut protein.

    Product
    Chocolate Chip, Frozen Pre-cut Cookie Dough, Net Weight: 24.61 lbs/11.17 kgs and 23.44 lbs/10.63 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1503-2016·2016-06-22

    Chef's Quality Canola Frying Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Chef's Quality Canola Frying Oil because bottles were reported to contain a high density polyethylene resin trim ring.

    Product
    Chef's Quality Canola Frying Oil for Heavy Duty Frying, Net Wt. 35 LBS (15.87 KG), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00938 1
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1998-2016·2016-06-22

    Siemens Biograph mCT-S(64) 4R PET/CT Scanners Recalled for Cover Bracket Defect

    Siemens Medical Solutions USA Inc. is recalling two Biograph mCT-S(64) 4R PET/CT scanners because a cover bracket may not be welded, posing a risk of the cover falling during service.

    Product
    Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1482-2016·2016-06-22

    CSM Bakery Recalls Oatmeal Raisin Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling frozen Oatmeal Raisin cookie dough because it contains undeclared peanut protein. Consumers should not eat the product.

    Product
    Oatmeal Raisin, TranSmart Frozen Pre-cut Cookie Dough, Contains Approx. 120 Cookies, Net Weight 22.5 lbs (10.22 kgs).
    Category
    Food
    Distribution
    19 states