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.

12826–12850 of 53082

  • HighFDA (Drugs)·D-0866-2023·2023-06-14

    Levsin injection recalled for manufacturing quality program discontinuation

    Viatris Inc. is recalling Levsin injection (hyoscyamine sulfate, 0.5 mg/ml) due to discontinuation of the quality assurance program that verifies product identity, strength, quality, and purity. The recall affects 2,736 boxes distributed to 10 distributors.

    Product
    Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1688-2023·2023-06-14

    Avanos Recalls ambIT Cassette Filters for Missing Air In-Line Filter

    Avanos Medical is recalling ambIT Cassette Filter Male Luer (Product Code 220266) because some units were potentially distributed without an air in-line filter component.

    Product
    ambIT Cassette Filter Male Luer, Product Code: 220266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2023·2023-06-14

    Surgical anchor inserter recalled for potential tip fracture and bone damage

    DePuy Mitek BIOKNOTLESS Rapid anchor inserters may fracture during use, potentially leaving fragments in the patient. If detected during surgery, removal could cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0997-2023·2023-06-14

    Chili Cacahuate Japones Snacks Recalled for Undeclared Peanut

    Werner Gourmet Meat Snacks recalls Chili Cacahuate Japones snacks due to undeclared peanut allergen. The product poses a serious risk to consumers with peanut allergies.

    Product
    Chili Cacahuate Japones, net weight 5 oz (127g), packaged in a soft teal colored plastic pouch with the UPC code 7 09972 80082 2. There are 6 pouches per case. Werner Gourmet Meat Snacks Inc. Tillamook, OR 97141. The label declares: INGREDIENTS: CHILI, RICE FLOUR, WHEAT FLOUR…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1677-2023·2023-06-14

    Surgical Anchor Inserter Tip Fragmentation During Patient Procedures

    DePuy Mitek's BIOKNOTLESS Plus anchor inserter may fragment during surgical use if bending force is applied. Fragments retained in the patient may require surgical removal, potentially causing bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0973-2023·2023-06-14

    Frozen Brat Roll Dough Recalled for Undeclared Egg Allergen

    Gonnella Frozen Products is recalling 949 cases of frozen brat roll dough due to undeclared egg. Egg was not disclosed on the product label.

    Product
    Brat Roll Frozen Dough Product Code 18429 UPC: 00078296184292. Individual unit wt 2.50 oz. Packaged in a cardboard box. 180 pieces per case.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0996-2023·2023-06-14

    Nature's Energy Children's Chewable Colostrum Recalled for Undeclared Milk Allergen

    Nature's Energy is recalling Children's Chewable Colostrum Orange Creamsicle (180 count) due to undeclared milk allergen on the label. Consumers with milk allergies could experience serious allergic reactions.

    Product
    Nature's Energy Children's Chewable Colostrum Orange Creamsicle, 180 count, UPC 804879183969 GTIN 860008676993
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0994-2023·2023-06-14

    Children's colostrum supplement recalled due to undeclared milk allergen

    Nature's Energy Children's Chewable Colostrum Berry supplement is recalled because the label does not declare milk allergen, despite containing bovine colostrum. The recall affects consumers with milk allergies.

    Product
    Nature's Energy Children's Chewable Colostrum Berry, 180 count, UPC 804879183945 GTIN 860008676979
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1698-2023·2023-06-14

    Magic3 Go Female Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard Inc is recalling Magic3 Go female intermittent urinary catheters worldwide due to a manufacturing defect where the resealing label can separate from the product pouch, potentially compromising product sterility.

    Product
    Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1685-2023·2023-06-14

    AVNS ambIT System infusion kits recalled for missing air filter

    Avanos Medical is recalling certain AVNS ambIT System infusion kits because some units may lack the required air in-line filter. Affected kits were distributed worldwide including the US (Texas and Oregon) and Australia.

    Product
    AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0972-2023·2023-06-14

    Blueberry Yogurt Parfaits Recalled for Undeclared Soy and Brown Sugar

    Sodexo Operations recalls simply to go Blueberry Yogurt Parfaits due to undeclared soy lecithin and brown sugar syrup. Consumers allergic to soy should not consume the product.

    Product
    simply to go Blueberry Yogurt Parfaits, 8.53oz, UPC 477088156552 and 477088150550; packaged in plastic cups
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1679-2023·2023-06-14

    DePuy Mitek surgical anchor inserter tip may fragment and be retained

    DePuy Mitek BIOKNOTLESS Plus surgical anchor inserters may have tips that break off during use and remain in the patient. This could require surgical removal that may cause bone damage.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2023·2023-06-14

    DePuy Mitek BIOKNOTLESS Plus Anchor Inserter Tip May Fracture During Surgery

    DePuy Mitek BIOKNOTLESS Plus anchor inserter tips may break and be retained in patients during surgery. Removal of fragments could cause bone damage and prolong surgery time.

    Product
    DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2023·2023-06-14

    Sterile Surgical Procedure Packs Recalled for Defective Light Handle Covers

    DeRoyal Industries is recalling 2,972 sterile surgical procedure packs containing light handle covers that have been recalled by another manufacturer. The affected packs were distributed to hospitals in Virginia.

    Product
    Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2023·2023-06-14

    Magic3 Go Pediatric Intermittent Urinary Catheters Recalled for Packaging Defect

    C.R. Bard Inc is recalling Magic3 Go pediatric intermittent urinary catheters due to a manufacturing defect where the resealing label can separate from the foil pouch, potentially compromising product sterility.

    Product
    Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1689-2023·2023-06-14

    TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size

    Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.

    Product
    The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2023·2023-06-14

    Presource Laparoscopy Kit Recalled for Lack of Sterility Assurance

    Cardinal Health is recalling Presource Kit laparoscopy surgical packs due to being released without sterility assurance. Affected units may harbor contamination and pose a risk during surgical procedures.

    Product
    Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0865-2023·2023-06-14

    Empower Pharmacy Ascorbic Acid Injection Mislabeled as Preserved

    Empower Pharmacy is recalling Ascorbic Acid 500 mg/mL injection solution because vials labeled as preserved are actually preservative-free. The 504 affected vials were distributed nationwide.

    Product
    ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2023·2023-06-14

    BD Veritor System Instructions for Use Not FDA Approved

    The Instructions for Use for BD Veritor System rapid diagnostic tests for COVID-19 and flu were not FDA-approved, lacking proper specimen type specifications. Using the test with invalid specimen types could produce false positive or negative results, potentially delaying diagnosis or treatment.

    Product
    BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0971-2023·2023-06-14

    Strawberry Yogurt Parfaits Recalled for Undeclared Soy Lecithin

    Sodexo is recalling simply to go Strawberry Yogurt Parfaits due to undeclared soy lecithin and brown sugar syrup. Consumers with soy allergies may be at risk.

    Product
    simply to go Strawberry Yogurt Parfaits, 8.53oz, UPC 477088125794; packaged in plastic cups
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1686-2023·2023-06-14

    SMMT ambIT Kit Basic Filter Luer Cass Recalled for Missing In-Line Filter

    Avanos Medical recalls SMMT ambIT Kit Basic Filter Luer Cass units that were distributed without the required air in-line filter component.

    Product
    SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0981-2023·2023-06-14

    Chocolate spread recalled for undeclared soy allergen

    DIBE LLC is recalling TETAS Mireya, SABOR Nutella chocolate spread due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    TETAS Mireya, SABOR Nutella
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1692-2023·2023-06-14

    Surgical Procedure Packs Recalled Due to Included Light Handle Covers

    DeRoyal Industries is recalling two models of custom surgical procedure packs because they contain light handle covers that were previously recalled by another manufacturer. The packs were distributed in Virginia.

    Product
    Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
    Category
    Medical Device
    Distribution
    Distributed nationwide