The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

351–375 of 3531

  • ModerateFDA (Drugs)·D-0111-2025·2024-12-11

    Pigmentation treatment product recalled for manufacturing process deviations

    Only Your Rx pigmentation product is being recalled due to manufacturing quality deviations in water systems used during production. The product was distributed in California only.

    Product
    10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0102-2025·2024-12-11

    Prescription drug esomeprazole magnesium recalled for labeling error

    Zydus Pharmaceuticals is recalling esomeprazole magnesium oral suspension because of an incorrect NDC number on package labeling. The affected product is lot M408002 distributed nationwide.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0591-2025·2024-12-11

    BD Synapsys Laboratory Informatics System Recalled for Service Credential Compromise

    BD is recalling the Synapsys Informatics Solution Version 444150 due to compromised service credentials used by technical support teams. Unauthorized access may compromise data confidentiality, integrity, and system availability.

    Product
    BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0625-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled for Defective Component

    Medline Industries is recalling 30,092 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; 2) AVF-LF, REF CDS840233I; 3) GENERAL AAA #11-RF, REF CDS840261AB; 4) HEART CDS, REF CDS840387T; 5) OPEN HEART CDS PART A, REF CDS840402AF; 6) OPEN HEART CDS PART A, REF CDS840402AI; 7) HEART PACK,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2025·2024-12-11

    MAXIM Assure Antibacterial Hand Soap Recalled for Microbial Contamination

    Midlab Incorporated is recalling MAXIM Assure Antibacterial hand soap (Lot 0711241) nationwide due to out-of-specification microbial test results in the manufacturing process.

    Product
    MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use Only, MIDLAB 140 Private Brand Way, Athens, TN 37303
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0642-2025·2024-12-11

    Medline Surgical Convenience Kits Recalled Over Supplier Component Recall

    Medline is recalling 336 surgical convenience kits manufactured with SafeAir Smoke Evacuation Pencils that Stryker previously recalled. The kits were distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0624-2025·2024-12-11

    Medline Surgical Kits Recalled for SafeAir Smoke Evacuation Pencils

    Medline is recalling 1,271 surgical convenience kits containing SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The affected kits were distributed nationwide, and healthcare facilities should discontinue use.

    Product
    MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2025·2024-12-11

    Medline Recalls Convenience Kits with Recalled SafeAir Smoke Evacuation Pencil

    Medline is recalling 1,921 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BRE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0633-2025·2024-12-11

    MEDLINE Recalls Medical Convenience Kits Containing Recalled SafeAir Component

    MEDLINE is recalling approximately 25,877 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0641-2025·2024-12-11

    Medline Surgical Convenience Kits Recalled for Defective Component

    Medline is recalling multiple surgical convenience kits because they contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker. The recall affects 1,952 units distributed nationwide; no injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0555-2025·2024-12-11

    Non-ablative Fractional Laser Systems WFB-01: Software Bug and Labeling Issues Recalled

    Non-ablative Fractional Laser Systems Model WFB-01 are recalled due to a software bug affecting 6 units sold to US customers before August 23, 2022, and labeling non-compliances affecting 22 units sold to US customers.

    Product
    Non-ablative Fractional Laser Systems, Model: WFB-01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0088-2025·2024-12-11

    Boardwalk Antibacterial Handsoap Refill Recalled for Microbial Specification Failure

    Midlab Incorporated is recalling boardwalk Antibacterial Handsoap Refill due to out-of-specification microbial test results. Affected lot 0711241 was distributed nationwide.

    Product
    boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North, Deerfield, IL 60015
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0594-2025·2024-12-11

    BD BACTEC FX40 Product Service Credentials Accessed by Unauthorized Actor

    Unauthorized actor accessed BD technical support credentials for the BACTEC FX40 laboratory instrument. Until credentials are updated, there is a risk of unauthorized access to the system and associated data.

    Product
    BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2025·2024-12-11

    Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component

    Medline is recalling 14,388 surgical convenience kits nationwide manufactured with certain lots of SafeAir Smoke Evacuation Pencils previously recalled by Stryker. Affected kits should not be used.

    Product
    MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2025·2024-12-11

    Medline Colon Wound Closure Packs recalled due to defective component

    Medline is recalling Colon Wound Closure Packs (REF DYNJ52141B) because they were manufactured using SafeAir Smoke Evacuation Pencils that were recalled by Stryker. The kits have been distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0646-2025·2024-12-11

    MEDLINE Surgical Kits Recalled Due to Defective SafeAir Component

    Medline is recalling 3,452 units of surgical convenience kits nationwide due to a defective SafeAir Smoke Evacuation Pencil component previously recalled by Stryker. No illnesses or injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0616-2025·2024-12-11

    GE Healthcare CT Scanner Console Images May Rotate After First Scan

    Certain GE Healthcare CT scanner systems may produce progressively rotated images after the first scan, with rotation up to 56 degrees. While anatomical data remains intact, misaligned images could necessitate patient rescans.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0587-2025·2024-12-11

    BD COR PX Instrument Service Credentials Compromised; Update Required

    Becton Dickinson reports that technical support credentials for the BD COR PX Instrument were accessed by an unauthorized actor. Users should verify credential updates with BD to mitigate unauthorized access risk.

    Product
    BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0092-2025·2024-12-11

    Compliance Dishwashing Liquid and Antibacterial Soap recalled for microbial contamination

    Midlab Incorporated is recalling Compliance brand dishwashing liquid and antibacterial soap due to microbiological contamination from manufacturing process deviations. The product was distributed nationwide; no illnesses have been reported.

    Product
    Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal Corporation, 10232 Palm Drive, Santa Fe Springs, CA 90670
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0609-2025·2024-12-11

    GE Healthcare Revolution Frontier CT systems may produce rotated images during scans

    GE Healthcare Revolution Frontier CT systems can produce progressively rotated images during helical, cine, and cardiac scans. The rotation can reach up to 56 degrees and may require repeat scans.

    Product
    GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0623-2025·2024-12-11

    Medline Medical Convenience Kits Recall Due to Recalled Component

    Medline is recalling certain medical convenience kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. The recall affects 182 units distributed nationwide.

    Product
    MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DYNJ0572894I; 2) LOCAL BASIC, REF DYNJ34418L; 3) LOCAL BASIC, REF DYNJ34418M; 4) MINI LOCAL, REF DYNJ900287D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0552-2025·2024-12-04

    Heart Device Transmitter Fails to Update Software After Power Interruption

    Abbott Medical's Merlin@home transmitter cannot upgrade to current software after power interruptions during prior downloads. This affects remote heart device monitoring systems.

    Product
    Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2025·2024-12-04

    Abbott Merlin@home Cardiac Monitoring Transmitters Fail to Update After Power Loss

    Abbott is recalling 130 Merlin@home cardiac transmitters that cannot update software after power interruption during firmware download. Affected devices remain on outdated firmware with no ability to receive future updates.

    Product
    Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0071-2025·2024-12-04

    FDA Recalls Cheeky Bonsai Menthol Pain Relief Patches for Manufacturing Deviations

    Cheeky Bonsai Pain Relief Patches (Menthol 10%) are being recalled nationwide due to manufacturing facility compliance deviations. The voluntary recall affects 17,928 patches distributed across the US.

    Product
    CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
    Category
    Drug
    Distribution
    Distributed nationwide