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.

7751–7775 of 22103

  • HighFDA (Devices)·Z-1452-2025·2025-04-02

    Medline arthroscopy procedure kits recalled for defective plastic syringes

    Medline is recalling arthroscopy procedure kits containing plastic syringes with defects including leaks and breakage. The syringes may pose a risk to patient health during surgical procedures.

    Product
    Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2025·2025-04-02

    Lap Pack Convenience Kits Recalled for Sterility Assurance Concerns

    American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.

    Product
    Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1450-2025·2025-04-02

    Medline Medical Procedure Kits With Plastic Syringes Recalled for Quality Issues

    Medline medical procedure kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health.

    Product
    Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2025·2025-04-02

    Medline surgical procedure kits recalled for syringe leaks and breakage

    Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2025·2025-04-02

    Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes

    Medline Industries is recalling 1,228 surgical procedure kits containing defective plastic syringes. The syringes may leak or break during use, potentially affecting patient safety.

    Product
    Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2025·2025-04-02

    Progressa bed surfaces recalled for mattress dips when head elevated

    Baxter Healthcare's Progressa Bed Surfaces may develop dips in the mattress when the head of the bed is elevated, as air bladders inside can shift out of position. This could reduce the bed's effectiveness at preventing pressure ulcers.

    Product
    Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, P7520A20S, P7520A21, P7520A22S, P7520A23, P7520A24S, P7520A3, P7520A31, P7520A37, P7520A39, P7520A45, and P7520A4S.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2025·2025-04-02

    Medline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues

    Medline is recalling 9,246 units of medical procedure kits containing defective plastic syringes with leaks and breakage that may pose a risk to patient health. The kits were distributed nationwide in the US and in Canada.

    Product
    Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2025·2025-04-02

    Baxter surgical table software issue blocks emergency back adjustment

    Baxter is recalling 112 units of the TruSystem 7500 surgical table due to a software issue preventing upper back adjustment during emergency mode. No injuries have been reported.

    Product
    Baxter Floor mounting column TruSystem 7500, Product Code 1717021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2025·2025-04-02

    Medline Procedure Kits With Defective Plastic Syringes Recalled

    Medline is recalling surgical procedure kits with plastic syringes affected by a March 2024 FDA Safety Alert due to leaks, breakage, and quality issues that may pose risks to patients.

    Product
    Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0293-2025·2025-04-02

    Strides Pharma Testosterone Gel Recalled Due to Benzene Contamination

    Strides Pharma is recalling Testosterone Gel 1% (195,952 cartons nationwide) due to benzene contamination. Consumers using affected lots should immediately contact their healthcare provider.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2025·2025-04-02

    Medline procedure kits with defective plastic syringes recalled due to leak and breakage risk

    Medline procedure kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may compromise sterile medical procedures. Approximately 14,589 units were distributed nationwide in the US and Canada.

    Product
    Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2025·2025-04-02

    Medline CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues

    Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.

    Product
    Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2025·2025-04-02

    Contact lenses for astigmatism recalled due to incorrect cylinder power

    CooperVision is recalling multiple brands of daily disposable toric contact lenses manufactured with incorrect cylinder power in certain lot codes. Users of affected lenses should stop wearing them and contact their eye care provider.

    Product
    Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUB
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1427-2025·2025-04-02

    CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues

    St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.

    Product
    CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1408-2025·2025-04-02

    Premier Solo Diamond dental burs recalled due to material hardness defect

    Premier Dental Products Co is recalling Premier Solo Diamond Large dental burs because the material hardness does not meet specifications and may cause the burs to bend during use. 77 units in six U.S. states are affected.

    Product
    Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2025·2025-04-02

    Baxter Operating Table Column Software Issue Limits Emergency Mode Function

    Baxter Healthcare is recalling 403 TS7500 MOBIUS operating table columns due to a software issue that prevents the upper back section from being adjustable when emergency mode is activated.

    Product
    Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0292-2025·2025-04-02

    Metformin Hydrochloride Extended-Release Tablets Recalled for Foreign Tablet Contamination

    A-S Medication Solutions is recalling 411 bottles of Metformin Hydrochloride Extended-Release 500mg tablets (Lot #4260340) distributed nationwide due to the presence of foreign tablets or capsules.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2025·2025-04-02

    Medline Arterial Pressure Monitoring Line Kits Recalled for Manufacturing Defect

    Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.

    Product
    namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0296-2025·2025-04-02

    Compounded Fentanyl-Bupivacaine Epidural Injections Recalled for Sterility Failure

    QuVa Pharma recalls compounded fentanyl-bupivacaine epidural injections due to lack of assurance of sterility. The recall affects 2,310 cassettes distributed nationwide.

    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2025·2025-04-02

    Checkpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk

    The adhesive on Checkpoint Guardian Intraoperative Leads may not fully cover metallic wire components, leading to potential electrical current leakage. This could result in inconsistent muscle responses and affect surgical effectiveness.

    Product
    Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1422-2025·2025-04-02

    Software Malfunction Disables Back Control on Baxter TruSystem 7500

    Baxter TruSystem 7500 medical devices are affected by a software issue that prevents the upper back section from operating when emergency mode is enabled. Approximately 1,709 units have been recalled nationwide.

    Product
    Baxter TruSystem 7500, Product Code 4091000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2025·2025-04-02

    Baxter TruSystem 7500 Hybrid software issue disables upper back adjustment

    Baxter TruSystem 7500 Hybrid affected by software issue that prevents the upper back section from being operable or adjustable when emergency mode is enabled. Affects 10 units distributed nationwide.

    Product
    Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0667-2025·2025-04-02

    Favorite Day Gourmet Cheesecake Recalled for Undeclared Pecan

    Favorite Day Gourmet New York-Style Cheesecake is recalled for containing undeclared pecan, a tree nut allergen not listed on the product label. The product was distributed to California, Florida, Iowa, Ohio, and Texas.

    Product
    favorite day gourmet New York-Style CHEESECAKE 2 SLICES NET WT 6OZ (170 g) UPC 0 85239 09690 1 Target Brands, Inc.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1447-2025·2025-04-02

    Medline procedure kits recalled for syringe quality defects

    Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety during medical procedures.

    Product
    Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide