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.

15476–15500 of 53092

HighFDA (Devices)·Z-0150-2023·2022-11-09
STRATAFIX Absorbable Sutures Recalled for Wrong Needle Type
Ethicon recalls STRATAFIX absorbable sutures after discovering some packages contain the wrong needle type. The PS-1 cutting edge needle instead of the intended SH taper point needle may cause more tissue trauma than anticipated.
Product
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0037-2023·2022-11-09
Injectable hormone medication recalled for sterility assurance failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Medroxyprogesterone Acetate 300 mg/mL suspension due to lack of sterility assurance. The product was produced in a manner that cannot guarantee sterility of the injectable medication.
Product
MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-0166-2023·2022-11-09
Medline CVC Barrier Kit Recalled for Breached Pouch Seals
Medline is recalling CVC barrier kits (Lot 22ABT774) due to breather pouches with seal openings that could compromise sterility of the surgical kit contents.
Product
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0131-2023·2022-11-09
Lactaid Cottage Cheese Recalled for Plastic Foreign Objects
HP Hood LLC is recalling Lactaid Cottage Cheese (16 oz) with best-by dates Oct 24 2022 to Dec 12 2022 due to possible plastic contamination. Consumers should discard or return affected products.
Product
Lactaid Cottage Cheese, 16 oz
Category
Food
Distribution
39 states
HighFDA (Devices)·Z-0165-2023·2022-11-09
Medline Radiology Procedure Pack Breather Pouches Recalled for Seal Defects
Medline is recalling 240 Radiology Procedure Packs because some breather pouches show seal openings that could compromise sterility. The affected kits were distributed nationwide.
Product
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0128-2023·2022-11-09
Hood Cottage Cheese with Pineapple Recalled for Possible Plastic Contamination
HP Hood LLC is recalling Hood Fat Free Cottage Cheese with Pineapple, 16 oz containers for possible plastic contamination. Affected products have best-by dates from October 24, 2022 through December 12, 2022.
Product
Hood Fat Free Cottage Cheese with Pineapple, 16 oz
Category
Food
Distribution
39 states
HighFDA (Food)·F-0127-2023·2022-11-09
Hood Everything Bagel Cottage Cheese Recalled for Plastic Fragments
HP Hood LLC is recalling Hood Everything Bagel Cottage Cheese due to the potential presence of plastic fragments. The recall affects approximately 391,824 cases distributed across 37 states with best-by dates from October 24 to December 12, 2022.
Product
Hood Everything Bagel Cottage Cheese, 16 oz
Category
Food
Distribution
39 states
HighFDA (Devices)·Z-0175-2023·2022-11-09
Operating Room Table With Defective Adhesive May Lose Mechanical Integrity
Baxter Healthcare is recalling Allen Advance operating room tables because adhesive securing fasteners may not cure properly, potentially compromising mechanical integrity.
Product
Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
Category
Medical Device
Distribution
4 states
HighFDA (Drugs)·D-0054-2023·2022-11-09
Pharmacy Plus Eye Solution Recalled for Sterility Assurance Issues
Pharmacy Plus is recalling SERUM TEARS IN NSAL 20% Ophthalmic Solution due to lack of assurance of sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.
Product
SERUM TEARS IN NSAL 20% OPTH SOLUTION, 3 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-0152-2023·2022-11-09
Implantable Defibrillator Software Error Causes Inaccurate Battery Display
Boston Scientific's EMBLEM MRI S-ICD implantable defibrillators contain a software defect with an incorrect manufacturing date that causes inaccurate battery capacity display. The recall affects 142 devices distributed worldwide.
Product
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0121-2023·2022-11-09
Cottage Cheese with Pineapple Recalled for Plastic Contamination
HP Hood LLC is recalling multiple brands of cottage cheese with pineapple due to possible plastic contamination. Products with best-by dates between October 24 and December 12, 2022 were distributed across 38 states.
Product
Food Club Cottage Cheese with Pineapple, 16 oz; Hannaford Cottage Cheese with Pineapple, 16 oz; Hood Cottage Cheese with Pineapple, 16 oz and 24 oz; Market Basket Cottage Cheese with Pineapple, 16 oz; Penn Maid Cottage Cheese with Pineapple, 16 oz;
Category
Food
Distribution
39 states
HighFDA (Drugs)·D-0032-2023·2022-11-09
Cyclosporin 0.07% Ophthalmic Solution Recalled Due to Sterility Concerns
Pharmacy Plus recalls 67 bottles of Cyclosporin 0.07% ophthalmic solution across four states due to manufacturing process that cannot guarantee sterility.
Product
CYCLOSPORIN 0.07% OPTH 0.07% Solution in 10 mL bottles, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0041-2023·2022-11-09
Compounded injectable medication recalled for lack of sterility assurance
Pharmacy Plus Inc. (Vital Care Compounder) is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections distributed in four states due to manufacturing conditions that cannot guarantee product sterility.
Product
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0053-2023·2022-11-09
Semaglutide Injection Recalled Due to Sterility Assurance Deficiency
The FDA is recalling semaglutide injection from Vital Care Compounder for lack of assurance of sterility. The recall affects specific lots distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-0162-2023·2022-11-09
Medline Lithotomy Sterile Surgical Kit Recalled for Compromised Breather Pouch Seal
Medline is recalling 96 sterile surgical kits (REF DYNJ50099C, Lot 22DBL482) distributed nationwide due to complaints of openings in breather pouches that compromise sterility and increase contamination risk.
Product
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0029-2023·2022-11-09
Compounded sterile drug solution recalled due to manufacturing sterility failure
Vital Care Compounder is recalling Brilliant Blue G Solution due to inability to assure product sterility. The recall involves 86 vials (Lot 60448) distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0038-2023·2022-11-09
Methylcobalamin Injection Recalled for Lack of Sterility Assurance
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of methylcobalamin injection solution. FDA inspection found manufacturing conditions that do not assure sterility.
Product
METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Food)·F-0105-2023·2022-11-09
Bella Cucina Pizza Mix Recalled for Undeclared Wheat Allergen
Bella Cucina Tradizionale Pizza and Foccacia Mix is being recalled because the label does not declare wheat, a common allergen. Consumers with wheat allergies could experience allergic reactions.
Product
Bella Cucina Artful Food Tradizionale Pizza and Foccacia Mix Net Wt. 15 oz 422g can, Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
Category
Food
Distribution
45 states
HighFDA (Drugs)·D-0056-2023·2022-11-09
FDA Recalls Vancomycin Intravitreal Injections for Sterility Defect
Pharmacy Plus Inc. is recalling vancomycin intravitreal eye injections due to FDA findings that sterility cannot be assured. The products were produced in a manner that does not guarantee they remain sterile.
Product
VANCOMYCIN INTRAVITREAL 1MG/0.1ML SOLUTION, 0.5 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0047-2023·2022-11-09
Papaverine HCL Stock Solution Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Papaverine HCL Stock Solution 30mg/ml vials due to lack of sterility assurance. FDA inspection found the product was produced in a manner that cannot guarantee sterility.
Product
PAPAVERINE HCL STOCK SOLUTION 30MG/ML SOLUTION, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Food)·F-0119-2023·2022-11-09
HP Hood Chive Cottage Cheese Recalled for Plastic Contamination
HP Hood LLC is recalling chive cottage cheese sold under multiple store brands due to potential plastic contamination. Approximately 391,824 cases distributed across 37 states.
Product
Food Club Chive Cottage Cheese, 16 oz; Hannaford Chive Cottage Cheese, 16 oz; Hood Chive Cottage Cheese, 16 oz and 24 oz; Price Chopper Chive Cottage Cheese, 16 oz; Market Basket CChive Cottage Cheese, 16 oz
Category
Food
Distribution
39 states
HighFDA (Drugs)·D-0045-2023·2022-11-09
Injectable Drug Recalled Over Failure to Assure Product Sterility
Vital Care Compounder is recalling a compounded injectable medication due to FDA findings that the manufacturing process failed to guarantee sterility. Two lots were distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Product
PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Food)·F-0098-2023·2022-11-09
Bella Cucina Fresh Basil Pesto Recalled for Undisclosed Milk Allergen
Bella Cucina Artful Food is recalling Fresh Basil Pesto because the label does not disclose milk. The product may cause allergic reactions in consumers with milk allergies.
Product
Bella Cucina Artful Food Fresh Basil Pesto Net Wt. 3 oz (84.5g) bag, UPC 6 19193 00211 3 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
Category
Food
Distribution
45 states
HighFDA (Food)·F-0100-2023·2022-11-09
Bella Cucina Spinach Artichoke Bruschetta Spread Recalled for Undisclosed Milk
Bella Cucina Artful Food is recalling Spinach Artichoke Bruschetta Spread because the label does not indicate milk. Consumers with milk allergies should not consume this product.
Product
Bella Cucina Artful Food Spinach Artichoke Bruschetta Spread Net Wt. 10 oz (286g) jar, UPC 6 19193 00501 5 Manufactured by Bella Cucina Artful Food Atlanta, GA 30310
Category
Food
Distribution
45 states
HighFDA (Devices)·Z-0147-2023·2022-11-09
Fogarty Biliary Balloon Probes recalled for latex deterioration
Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.
Product
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Category
Medical Device
Distribution
Distributed nationwide