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.

14376–14400 of 53090

HighFDA (Devices)·Z-1093-2023·2023-02-15
Sterile Surgical Trays Recalled for Blade Puncture Risk
Medline Industries recalls sterile surgical procedural trays because blades inside could puncture the outer sterile packaging, potentially compromising kit sterility.
Product
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1102-2023·2023-02-15
Smart Correction External Fixation Struts: Collar Release Pin May Back Out
The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.
Product
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0268-2023·2023-02-15
Posaconazole Antifungal Tablets Recalled for Degradation Impurities
Biocon Pharma Inc. is recalling Posaconazole Delayed-Release Tablets due to failed degradation specifications and out-of-specification impurities that may compromise medication safety and efficacy.
Product
POSACONAZOLE — POSACONAZOLE (POSACONAZOLE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1075-2023·2023-02-15
Sterile endoscopy trays recalled for potential blade packaging puncture
Medline is recalling sterile procedural trays labeled GENERAL ENDOSCOPY because sterile blades within the kits may puncture the outer foil layer of sterile packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2023·2023-02-15
Medline Sterile Procedural Trays Recalled Over Blade Puncture Risk
Medline recalls sterile procedural trays because sterile blades may puncture the outer foil packaging, compromising device sterility. The 314-case recall affects hospitals in the US, Canada, Japan, Mexico, Panama, Turks & Caicos, and UAE.
Product
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1065-2023·2023-02-15
Blade Puncture Risk in Femoral Artery Sterile Procedural Trays
Medline's Femoral Artery Sterile Procedural Trays are being recalled because sterile blades within the kits can puncture the outer foil layer of the sterile packaging. This puncture creates a contamination risk.
Product
FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1070-2023·2023-02-15
Sterile Procedural Trays recalled for potential blade puncture of packaging
Medline Industries is recalling five types of sterile procedural trays because sterile blades inside can puncture the outer foil packaging, potentially compromising sterility and creating contamination risk.
Product
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1106-2023·2023-02-15
Roche Influenza A/B and RSV Test Kit Recalled for False Negative Results
Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.
Product
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1090-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Packaging Compromise
Medline Industries recalls sterile pelviscopy trays because blades inside may puncture the protective foil packaging, potentially compromising sterility. 316 units distributed worldwide are affected.
Product
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2023·2023-02-15
Medline Sterile Procedural Trays Risk Package Puncture and Sterility Compromise
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer foil packaging, potentially compromising sterility. The recall affects 858 units distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1077-2023·2023-02-15
Sterile Surgical Trays Recalled for Blade Puncture of Packaging
Medline Industries is recalling sterile surgical trays used in plastic and reconstructive surgery because blades within the kits can puncture the outer foil packaging, potentially compromising sterility. Approximately 15,009 units were distributed nationwide and internationally.
Product
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINOPLASTY CDS d. ACH PLASTICS BREAST-LF e. NE BREAST RECON CDS f. PLASTIC SURGERY CDS g. MINOR PLASTIC CDS h. GROTH BREAST CDS i. BREAST ABD j. MINOR/U-BAR…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0341-2023·2023-02-15
Hartzler Family Dairy Eggnog Recalled for Missing Ingredient List
Hartzler Family Dairy is recalling 6,000 units of Nice List Eggnog quarts due to missing ingredient labeling. Consumers cannot identify product ingredients or potential allergens.
Product
Hartzler Family Dairy Wooster Ohio Nice List Eggnog '22 - Quart Size
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1084-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Packaging Puncture
Medline Industries is recalling sterile procedural trays because sterile blades may puncture the outer packaging foil, potentially compromising sterility. No injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: MINOR BASIC PACK-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2023·2023-02-15
Roche cobas Influenza Test Recall Due to False Negative Results
Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.
Product
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Potential Blade Puncture of Packaging
Medline Industries recalls sterile procedural trays (Wound Closure Tray and Wound Pack) distributed worldwide because sterile blades may puncture the outer foil packaging.
Product
Sterile Procedural Trays, labeled as the following: a. WOUND CLOSURE TRAY b. WOUND PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2023·2023-02-15
Medline Sterile Surgical Trays Recalled Due to Blade Puncture Risk
Medline Industries recalls sterile surgical procedural trays because sterile blades within the kits may puncture the outer foil packaging, potentially compromising sterility. No injuries or illnesses have been reported.
Product
Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0263-2023·2023-02-15
Ohm Hand Sanitizer Recalled for Acetaldehyde and Acetal Contamination
Urban Electric Power is recalling Ohm Hand Sanitizer products in multiple sizes due to FDA findings of acetaldehyde and acetal above specification limits resulting from manufacturing deviations.
Product
Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0340-2023·2023-02-15
Fiber Powder Dietary Supplement Recalled for Cronobacter sakazakii Contamination
Ortho Molecular Products is recalling fiber powder dietary supplements due to Cronobacter sakazakii detected in raw material. About 4,929 bottles distributed nationwide and to Canada are affected.
Product
Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the following brands and sizes. 1. Ortho Molecular Products Fiber Plus, Product #608445, Net Wt. 15.9 oz (450 Grams) UPC 6 15033-00608 2. Ortho Molecular Products, Inc., 3017 Business Park Drive…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1089-2023·2023-02-15
Sterile surgical trays recalled due to packaging puncture risk
MEDLINE INDUSTRIES is recalling six models of sterile surgical trays due to a potential for blades within the kits to puncture the sterile packaging. Affected trays were distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2023·2023-02-15
Sterile Procedural Trays With Blades That May Puncture Packaging
Medline recalls sterile surgical trays because internal blades can puncture the outer protective foil packaging, potentially compromising sterility.
Product
Sterile Procedural Trays, labeled as the following: a. C-SECTION OR 30 CDS b. C-SECTION CDS c. C-SECTION CDS d. C-SECTION CDS e. MAJOR ORTHO CDS-LF f. C-SECTION CDS g. C-SECTION CDS h. C-SECTION PROCEDURE i. C-SECTION CDS-LF j. C-SECTION CDS k. C-SECTION CDS l.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2023·2023-02-15
Sterile Procedural Trays Recalled Due to Blade Puncture Risk
Medline Industries is recalling sterile procedural trays because sterile blades within the kits may puncture the protective foil packaging. Approximately 12,964 cases (23,379 units) distributed worldwide are affected.
Product
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1073-2023·2023-02-15
Sterile Procedural Trays Recalled for Potential Blade Puncture
Medline sterile procedural trays for minor and breast biopsies are being recalled because sterile blades may puncture the outer foil packaging, compromising sterility. The recall affects 237 cases (1,242 units) distributed worldwide.
Product
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1083-2023·2023-02-15
Medline Sterile Procedural Trays Recalled for Potential Blade Puncture in Packaging
Medline Industries is recalling sterile procedural trays because blades in the kits may puncture the outer foil sterile packaging, compromising sterility. No injuries have been reported.
Product
Sterile Procedural Trays, labeled as the following: a. MAJOR CDS-LF b. BURN PACK-LF c. BURN PACK d. SMALL BURN
Category
Medical Device
Distribution
Distributed nationwide
HighUSDA FSIS·PHA-02152023-01·2023-02-15
USDA Issues Public Health Alert for Frozen Signature Select Breakfast Bowls
USDA FSIS issued a public health alert for frozen Signature Select Breakfast Bowls due to possible temperature abuse at a distribution center. Consumers are urged not to consume the products.
Product
FSIS Issues Public Health Alert for Frozen, Not-Ready-To-Eat Signature Select Breakfast Bowl Products Due to Possible Temperature Abuse at Distribution Center
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1062-2023·2023-02-15
Medline sterile procedural trays recalled for blade packaging puncture
Medline is recalling sterile procedural trays (Lot 22IBG550) because sterile blades can puncture the foil packaging, compromising sterility. Units were distributed worldwide.
Product
LOCAL PACK. Sterile Procedural Tray.
Category
Medical Device
Distribution
Distributed nationwide