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.

2476–2500 of 21589

  • ModerateFDA (Devices)·Z-3183-2024·2024-09-25

    Emergency Hypothermia Management Kits Recalled for Incorrect Expiration Dates

    Safeguard US Operating LLC is recalling 567 units of HAWK warming kits due to incorrect expiration date labeling. The kits were distributed nationwide in 16 states.

    Product
    Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3162-2024·2024-09-25

    Marodyne-LiV vibration exerciser recalled for power supply voltage defect

    Marodyne-LiV low-intensity vibration exercisers with certain serial numbers are recalled due to a power supply voltage drop that unexpectedly interrupts treatment. Manual activation is required to restart the device.

    Product
    Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3184-2024·2024-09-25

    BinaxNOW Respiratory Strep A Test Kits Shipped to Unlicensed Purchasers

    Cypress Medical Products is recalling BinaxNOW Respiratory Strep A Test Kits due to an inventory system error that resulted in shipment to customers without proper licensing to purchase medical devices.

    Product
    BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3160-2024·2024-09-25

    GE Healthcare Centricity Universal Viewer Recall for Report Display Issue

    GE Healthcare is recalling 803 units of the Centricity Universal Viewer Zero Footprint Client because the latest addended report may not display by default in specific browsers.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3154-2024·2024-09-25

    McKesson 60 mL Syringes Recalled Lacking FDA Clearance

    Cypress Medical Products is recalling McKesson 60 mL syringes that lack FDA clearance. The syringes were inadvertently shipped from a distribution center due to an order processing error and were on quarantine.

    Product
    General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·24368·2024-09-19

    Wee Gallery Baby Tummy Time Gallery Recalled for Phthalate Violation

    Wee Gallery is recalling about 8,000 Baby Tummy Time Gallery products because the clear plastic pockets contain phthalate levels that exceed federal limits. Phthalates are toxic if ingested by young children.

    Product
    Baby Tummy Time Gallery
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateNHTSA·24T010000·2024-09-18

    Goodyear Recalls Hercules Tires for Missing Identification Markings

    Goodyear is recalling specific Hercules Terra Trac AT X-Venture tires because they lack the required week and year code on the tire identification number.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1806-2024·2024-09-18

    Walmart Macaroni Salad Recalled Due to Foreign Material

    Reser's Fine Foods is recalling Walmart Original Freshness Guaranteed Macaroni Salad due to foreign material contamination. Affected product has UPC 78742 02670 with a Use By date of Sep 18, 2024.

    Product
    UPC 78742 02670, Walmart Original Freshness Guaranteed Macaroni Salad 3lb. (48oz), refrigerated, packaged in an opaque printed plastic tub with a plastic white printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-3098-2024·2024-09-18

    Vital Signs Monitor Recalled Due to Inadequate Battery Warning Labels

    Zoe Medical is recalling 6,429 Spacelabs Ultraview DM3 Vital Signs Monitors because labeling does not adequately warn users about risks from damaged or expired batteries.

    Product
    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3120-2024·2024-09-18

    Medline recalls surgical convenience kits in Class II recall

    Medline Industries is voluntarily recalling 720 units of convenience kits containing semi-rigid suction liners used in eye surgery and related procedures. The specific reason for the recall has not been disclosed.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923B; d) AMB OCULOPLASTICS MUSC, Pack Number DYNJ59923BH;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0658-2024·2024-09-18

    Fluoride Dental Product Recalled Due to Label Mix-Up

    Just Right 5000 fluoride dental product is being recalled due to a label mix-up affecting 120 direct customers nationwide.

    Product
    Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3079-2024·2024-09-18

    FDA Recalls Syringe Tip Caps Due to Unapproved Device Modifications

    Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.

    Product
    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3095-2024·2024-09-18

    Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears Recalled for Packaging Seal

    Medline is recalling 46 units of reprocessed Ethicon Harmonic ACE+7 Shears due to a potential incomplete seal on the packaging tray.

    Product
    Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1804-2024·2024-09-18

    Amazon Fresh Macaroni Salad recalled for foreign material contamination

    Reser's Fine Foods is recalling Amazon Fresh Fresh Classic Macaroni Salad due to foreign material contamination. The product was distributed in nine states with a use-by date of September 13, 2024.

    Product
    UPC 95515 04502, Amazon Fresh Fresh Classic Macaroni Salad 16oz, refrigerated, packaged in a clear plastic tub with printed labels on top, bottom and side. There are 12 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-3066-2024·2024-09-18

    Ultradent Recalls Vit-l-escence Composite Due to Red Particulates

    Ultradent is recalling Vit-l-escence Singles A3 composite restorative material because a manufacturing issue resulted in red particulates being present in the expressed composite.

    Product
    Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% fi
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-3094-2024·2024-09-18

    Reprocessed Surgical Sealer/Divider Recalled for Potential Packaging Seal Defect

    Medline Industries is recalling the ReNewal Reprocessed Covidien LigaSure Impact Sealer/Divider due to a potential incomplete seal on the packaging tray. The recall affects 230 units nationwide.

    Product
    Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3103-2024·2024-09-18

    Diagnostic test shows measurement bias at critical threshold

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.

    Product
    ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3132-2024·2024-09-18

    Zimmer GmbH Recalls Mislabeled Biolox Option Taper Sleeve for Hip Replacement

    Zimmer GmbH is recalling 69 units of Biolox Option Taper Sleeves due to incorrect packaging labels. The outer box may identify the wrong neck size, potentially leading to the use of the wrong device.

    Product
    Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1802-2024·2024-09-18

    Reser's Spicy Pickle Potato Salad Recalled for Foreign Material

    Reser's American Classics Spicy Pickle Potato Salad (16 oz, UPC 71117 19084) is being recalled due to possible foreign material contamination. The voluntary recall affects products distributed across nine states.

    Product
    UPC 71117 19084, Reser's American Classics Spicy Pickle Potato Salad 16oz, refrigerated, packaged in an opaque printed plastic tub with a plastic red printed lid. There are 6 tubs per case.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-3112-2024·2024-09-18

    Medline Suction Liners Recalled Due to Potential Loss of Suction

    Medline is recalling 1,616 units of semi-rigid suction liners (ENDO KIT, pack numbers DYKE1350D and DYKE1514B) manufactured September to November 2023 that may lose or provide reduced suction during use.

    Product
    Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3129-2024·2024-09-18

    Medical Action Industries Recalls Foam Protective Pouches Due to Labeling Error

    Medical Action Industries is recalling foam protective pouches because they were improperly labeled with incorrect GMDN codes, leading to product misuse.

    Product
    Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350 each/case)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3073-2024·2024-09-18

    Medtronic InterStim Handset May Fail to Pair with Communicator

    Medtronic is recalling 211 InterStim Smart Programmer handsets that may not complete the pairing process with the communicator during initial setup.

    Product
    Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·24V686000·2024-09-13

    2025 Rivian R1S Recall: Missing Cruise Control Markings

    Rivian is recalling 33 2025 R1S vehicles because the steering column control module may be missing cruise control markings. Without proper markings, drivers may not know how to use the cruise control, potentially increasing crash risk.

    Product
    RIVIAN — RIVIAN R1S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2960-2024·2024-09-11

    Impella CP Cardiac Assist Pump Lacks Shockwave Catheter Interaction Warning

    Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.

    Product
    Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
    Category
    Medical Device
    Distribution
    Distributed nationwide