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.

4951–4975 of 52956

HighFDA (Devices)·Z-1401-2025·2025-03-26
Cardiovascular Information System Measurement Inconsistency in Merge Cardio
Merge Healthcare's VERICIS Merge Cardio cardiovascular information system may display inconsistent measurements under specific workflows involving ultrasound remeasurement or manual measurement editing. No illnesses have been reported.
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1395-2025·2025-03-26
Zebra Thermal Barcode Printer power supply units recalled due to fire hazard
Remel, Inc. is recalling approximately 41 Zebra Thermal Barcode Printer GX430t power supply units due to a potential fire hazard. The power supplies may overheat, creating a fire risk.
Product
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1351-2025·2025-03-26
EAR PACK Medical Device Recalled Over Unconfirmed Sterilization
American Contract Systems Inc is recalling 51 kits of the EAR PACK Model SFEA12A because the manufacturer could not confirm sterilization requirements were met, which could cause device malfunction and delayed treatment.
Product
EAR PACK , Model No SFEA12A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1400-2025·2025-03-26
VERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue
VERICIS Merge Cardio cardiovascular imaging software may display measurement values in patient reports that do not match original measurements when measurements are remeasured or manually edited. This affects 66 units distributed in the United States.
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0289-2025·2025-03-26
FDA Recalls Subpotent CURAD Alcohol Prep Pads Nationwide
Medline Industries is recalling CURAD Alcohol Prep Pads nationwide because they are subpotent. The recalled pads are sterile, medium, 2-ply alcohol prep pads distributed nationally.
Product
CURAD ALCOHOL PREP PADS — CURAD ALCOHOL PREP PADS (ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0642-2025·2025-03-26
emd Oysterettes Oyster Crackers Recalled for Metal Contamination
Dairy State Foods Inc is recalling emd Oysterettes oyster crackers due to the possibility of metal contamination. Affected batches have date codes 34824 and 35324 and were distributed in Michigan.
Product
emd Oysterettes (oyster crackers in polypropylene film). 0.75 oz. Packed for and Distributed by emd, Detroit, MI 48212.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1397-2025·2025-03-26
IV Catheter Valve Housing May Detach and Cause Leakage
B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.
Product
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-1388-2025·2025-03-26
DxI 9000 Access Immunoassay Analyzer Encoder Wheel Misalignment
Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer (206 units) because an encoder wheel misalignment on the motor shaft can cause the instrument to stop and delay patient test results.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0280-2025·2025-03-26
Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications
Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.
Product
PRASUGREL — PRASUGREL (PRASUGREL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0649-2025·2025-03-26
Chocolate Peanut Butter Protein Balls Recalled for Undeclared Allergens and Food Additives
Prep'd CDA LLC is recalling Chocolate Peanut Butter Protein Balls due to undeclared soy lecithin and undeclared food color additives. Consumers with soy allergies should not consume the product.
Product
Chocolate Peanut Butter Protein Balls. Product has expected life of 2 weeks and does not require refrigeration. Product is packaged in sets of 2 protein balls into resealable plastic baggies. Net Wt. 78 grams.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1389-2025·2025-03-26
Candida ID Antigen recalled for reduced sensitivity, potential false negatives
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
Product
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1366-2025·2025-03-26
Proxima Drape surgical drapes recalled due to potential sterility loss
Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.
Product
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2025·2025-03-26
Birth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
Product
BORN ON ARRIVAL KIT , Model No LLBN11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0644-2025·2025-03-26
HOT ONES Verde hot sauce recalled for possible plastic contamination
HOT ONES brand VERDE hot sauce by Heatonist is being recalled due to possible plastic foreign object contamination. Multiple sizes were distributed in North Carolina, Ohio, Indiana, and Illinois.
Product
HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST; 1 gallon, 5 oz, and 5 gallon sizes; UPC: 8-51444-00803-5
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1340-2025·2025-03-26
General Angio Pack Sterilization Assurance Cannot Be Confirmed
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
Product
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2025·2025-03-26
PICC Line Catheters Recalled for Sterilization Assurance Issues
American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.
Product
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1357-2025·2025-03-26
General Laparoscopic Pack Recall Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Product
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1399-2025·2025-03-26
VERICIS Merge Cardio may display inconsistent measurement data in clinical reports
The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0648-2025·2025-03-26
Dried Longan Pulp Recalled for Elevated Sulfite Levels
Growland Inc. is recalling Dried Longan Pulp products due to elevated sulfite levels. The affected product was distributed across seven states.
Product
Dried Longan Pulp- Made in China, 8oz(227g), GROWLAND INC. rear panel- Organic Planted, Store in cool and dry place, Made in Thailand; UPC# 8 513041 327262
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-1379-2025·2025-03-26
CO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect
Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1352-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
Product
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1365-2025·2025-03-26
Sterile Surgical Drape Recalled Due to Potential Packaging Breach
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
Product
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0659-2025·2025-03-26
Vanilla shakes recalled due to potential Listeria contamination
Lyons Magnus LLC is recalling Ready Care and Imperial brand vanilla shakes (4 oz) due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, skilled nursing homes, and hospitals across the U.S.
Product
Ready Care Vanilla Shake No Sugar Added (4 oz), UPC 10045796017365; Imperial Vanilla Shake No Sugar Added (4 oz), UPC 00074865927031
Category
Food
Distribution
0 states
HighFDA (Drugs)·D-0278-2025·2025-03-26
Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity
Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg due to nitrosamine impurity above acceptable daily intake limits. 56,790 bottles were distributed to 8 wholesalers nationwide.
Product
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0286-2025·2025-03-26
Injectable Drug Recalled for Stability Issues at Expiration
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.
Product
NEUPOGEN — NEUPOGEN (FILGRASTIM)
Category
Drug
Distribution
Distributed nationwide