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.

15451–15475 of 53092

HighFDA (Devices)·Z-0178-2023·2022-11-09
Beach Chair Clamp Shoulder Positioner recalled for adhesive curing failure
Baxter Healthcare recalls Beach Chair Clamp shoulder positioner components because adhesive on the fasteners may not cure properly, potentially reducing the device's mechanical integrity during surgical procedures.
Product
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the patients head in surgical procedures.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0177-2023·2022-11-09
Allen Spine Positioner Components Recalled for Adhesive Curing Defect
Baxter Healthcare is recalling Allen Standard Starburst spine positioning components due to adhesive that may not cure correctly, potentially compromising mechanical holding force in surgical head positioning devices.
Product
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.
Category
Medical Device
Distribution
4 states
HighFDA (Food)·F-0101-2023·2022-11-09
Bella Cucina Sun-Dried Tomato Pesto Recalled for Undeclared Milk Allergen
Bella Cucina Artful Food sun-dried tomato pesto is being recalled because the label does not indicate the presence of milk, a major allergen. Consumers with milk allergies are at risk.
Product
Bella Cucina Artful Food Sun-Dried Tomato Pesto Net Wt. 3 oz (84.5g) jar, UPC 6 19193 00213 7 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
Category
Food
Distribution
45 states
HighFDA (Devices)·Z-0167-2023·2022-11-09
NICU PICC Insertion Bundle Recalled for Breather Pouch Seal Defects
Medline Industries recalls NICU PICC insertion bundles (50 kits) due to openings in breather pouch seals that compromise sterile barrier integrity. This Class II recall affects units distributed across the United States.
Product
CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0024-2023·2022-11-09
Buprenorphine and Naloxone Sublingual Tablets Recalled for Foreign Substance
Sun Pharmaceutical is recalling buprenorphine and naloxone sublingual tablets (8 mg/2 mg) due to a foreign substance. Affected lots DNC1129A and DNC1740A were distributed nationwide.
Product
BUPRENORPHINE AND NALOXONE — BUPRENORPHINE AND NALOXONE (BUPRENORPHINE AND NALOXONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0129-2023·2022-11-09
Hood Lowfat Cottage Cheese recalled due to plastic foreign objects
HP Hood LLC is recalling Hood Lowfat Cottage Cheese (16 oz and 24 oz) with best-by dates Oct 24–Dec 12, 2022, because the product may contain plastic foreign objects.
Product
Hood Lowfat Cottage Cheese, 16 oz and 24 oz
Category
Food
Distribution
39 states
HighFDA (Devices)·Z-0163-2023·2022-11-09
Medline LINQ Surgical Trays Recalled for Compromised Pouch Seals
Medline has recalled LINQ TRAY surgical kits with breather pouch seal openings that could compromise sterility. The recall affects 40 kits distributed nationwide; no injuries have been reported.
Product
MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2023·2022-11-09
Surgical Cataract Kits Recalled for Defective Breather Pouch Seals
Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.
Product
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0159-2023·2022-11-09
Surgical eye kits recalled for breached sterile pouches
Medline Industries recalls Bausch + Lomb eye muscle surgical kits due to breached breather pouches that may compromise sterility. The affected kits (Lot 22DBN366) were distributed nationwide.
Product
BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0028-2023·2022-11-09
FDA Recalls Vital Care Autologous Tears Serum Due to Sterility Assurance Failure
Vital Care Compounder's Autologous Tears Serum Full Strength has been recalled due to manufacturing defects that cannot assure product sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
AUTOLOGUS TEARS SERUM SOLN FULL STRENGTH, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-0161-2023·2022-11-09
Surgical Cataract Packs with Compromised Breather Pouch Seals Recalled
Medline recalls 708 Bausch + Lomb cataract surgical packs due to breather pouch seal defects that could compromise sterility of surgical instruments.
Product
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0095-2023·2022-11-09
Bella Cucina Pastry Tarts Recalled for Undisclosed Milk Allergen
Bella Cucina Artful Food is recalling Crostata Sweet Butter Pastry Tarts because the label fails to indicate the presence of milk, a major allergen. Affected units were distributed across all U.S. states and internationally.
Product
Bella Cucina Artful Food CROSTATA SWEET BUTTER PASTRY TARTS Net Wt. 2.6 oz (73g) box, Distributed by Bella Cucina Artful Food Atlanta, GA 30310 UPC 6 19193 00721 7
Category
Food
Distribution
45 states
HighFDA (Drugs)·D-0033-2023·2022-11-09
Glycerin Ophthalmic Drops Recalled Due to Sterility Manufacturing Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Glycerin Ophthalmic Drops 98.5% Solution because manufacturing methods cannot guarantee the sterility of the product. Products affected are distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
GLYCERIN OPHTHALMIC DROPS 98.5% Solution, 10 mL droptainer, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Food)·F-0104-2023·2022-11-09
Bella Cucina Sweet Pumpkin Pesto fails to declare milk allergen
Bella Cucina Sweet Pumpkin Pesto (6 oz jars, UPC 6 19193 00144 4) does not indicate milk on the label, posing a risk for consumers with milk allergies. The product was distributed across most US states, Canada, and Italy.
Product
Food Sweet Pumpkin Pesto Net Wt. 6 oz (169g) jar, UPC 6 19193 00144 4 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
Category
Food
Distribution
45 states
HighFDA (Food)·F-0097-2023·2022-11-09
Bella Cucina Dried Cherry and Almond Biscotti Recalled for Undeclared Milk and Wheat
Bella Cucina Artful Food is recalling Dried Cherry and Almond Biscotti because the label fails to indicate the presence of milk and wheat allergens. Consumers with allergies to these ingredients should not consume the product.
Product
Bella Cucina Artful Food Dried Cherry and Almond Biscotti Net Wt. 6 oz (170g) bag, UPC 6 19193 00019 5 Distributed by Bella Cucina Artful Food Atlanta, GA 30310
Category
Food
Distribution
45 states
HighFDA (Devices)·Z-0151-2023·2022-11-09
Boston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error
Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires replacement.
Product
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0132-2023·2022-11-09
Pasta Salad Products Recalled for Undeclared Cashew Allergen
Craftology and Dutch Treat Foods pasta salads are recalled due to undeclared cashew allergen. The products were distributed in Michigan.
Product
Craftology This Is My Happy Place Handcrafted Pasta Salad 14oz clear plastic clamshell, UPC 8 55034 00649 4, 6 units per wholesale case. Dutch Treat Foods Sweet Pea Pasta Salad 10 pound case (2, 5 pound plastic bags per case), 20 pound and 30 pound buckets
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0048-2023·2022-11-09
Compounded Injectable Medication Recalled for Lack of Sterility Assurance
Vital Care Compounder is recalling an injectable medication (Papaverine/Phentolamine/Prostaglandin) because FDA inspection found production methods cannot guarantee product sterility. The recalled lot was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN INJ 150/5/50MCG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Food)·F-0099-2023·2022-11-09
Bella Cucina Porcini & Parmesan Pesto Recalled for Missing Milk Allergen Labeling
Bella Brands is recalling multiple lots of Bella Cucina Porcini & Parmesan Pesto because milk is not indicated on the product label, creating a risk for consumers with milk allergies.
Product
Bella Cucina Artful Food Porcini & Parmesan Pesto Net Wt. 6 oz (169g) jar, UPC 6 19193 00146 8 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
Category
Food
Distribution
45 states
HighFDA (Devices)·Z-0164-2023·2022-11-09
Medline Dental Pack Recall Due to Breather Pouch Seal Defect
Medline is recalling Dental Pack surgical kits (Lot 22DBE139) because breather pouches have openings in their seals that could compromise sterility. Affected units were distributed to healthcare facilities in eight US states.
Product
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0102-2023·2022-11-09
Bella Cucina Sweet Pepper Pesto recalled due to undeclared milk allergen
Bella Cucina Artful Food Sweet Pepper Pesto is being recalled because the label does not declare milk as an ingredient. Consumers with milk allergies could experience a serious allergic reaction.
Product
Bella Cucina Artful Food Sweet Pepper Pesto Net Wt. 3 oz (84.5g) jar, UPC 6 19193 00233 5 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
Category
Food
Distribution
45 states
HighFDA (Drugs)·D-0036-2023·2022-11-09
Lidocaine-Epinephrine Injectable Solution Recalled for Sterility Assurance Issues
Vital Care Compounder is recalling 7 syringes of Lidocaine-Epinephrine solution due to lack of sterility assurance. FDA inspection found the products cannot be guaranteed to be sterile.
Product
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-0176-2023·2022-11-09
Baxter Neurosurgical Headrest Recalled Due to Defective Adhesive
Baxter Healthcare is recalling C-Flex Polar Head Positioning Device neurosurgical headrests because adhesive on fasteners may not cure correctly, potentially compromising mechanical integrity and holding force.
Product
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0155-2023·2022-11-09
Surgical Eye Kit Pouches Recalled for Seal Defects
Medline recalls Bausch + Lomb Eye surgical kits due to breather pouches with openings in the seal. Affected kits were distributed to healthcare facilities nationwide; unopened kits should not be used.
Product
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0180-2023·2022-11-09
Surgical Positioning Clamp Adhesive May Fail to Cure Properly
Baxter Healthcare is recalling Simple Clamp surgical positioning equipment because the adhesive may not cure properly, reducing mechanical integrity during use. Affected units were distributed across multiple US states and international locations.
Product
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, forearm, arm, and shoulder in surgical procedures.
Category
Medical Device
Distribution
4 states