Drugs & medicalClass II

Happiest Baby, Inc recalls Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110

Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Read the official notice →
Date
2026-09-23
Country
United States
Brand
Happiest Baby
Product
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Classification
Class II
Units
US Nationwide distribution including in the states of Alabama, Alaska,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Happiest Baby recalls

  1. 2026-08-12
  2. US
    Drugs & medicalClass II

    Happiest Baby, Inc recalls Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000

    This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.

    FDA · DeviceHappiest Baby, IncUS Nationwide distribution in states of PA, WA, CA, NJ.Official notice →
All 2 Happiest Baby recalls →

Other drugs & medical recalls in the United States

  1. 2026-09-23
  2. US
    Drugs & medicalClass II

    embecta Medical II LLC recalls EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100

    Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

    FDA · Deviceembecta Medical II LLCUS Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA,…Official notice →
  3. US
    Drugs & medicalClass II

    restor3d Inc. recalls Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

    Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants,…

    FDA · Devicerestor3d Inc.US Nationwide distribution in the states of FL, CO.Official notice →
  4. US
    Drugs & medicalClass II

    Wilson-Cook Medical Inc. recalls Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU,…

    Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).

    FDA · DeviceWilson-Cook Medical Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
  5. US
    Drugs & medicalClass II

    PTW FREIBURG recalls Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;

    When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment…

    FDA · DevicePTW FREIBURGWorldwide - US Nationwide distribution in the states of GA, NY and the…Official notice →
  6. US
    Drugs & medicalClass II

    Straumann USA LLC recalls GM Helix Implant, REF: 109.984;

    There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

    FDA · DeviceStraumann USA LLCUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS,…Official notice →
  7. US
    Drugs & medicalClass II

    WELL LEAD MEDICAL CO. LTD recalls SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25

    The 6Fr suction catheter could not pass through the samples smoothly.

    FDA · DeviceWELL LEAD MEDICAL CO. LTDUS Nationwide distribution in the state of MI.Official notice →
See all drugs & medical recalls →