Drugs & medicalClass II

Ethicon, Inc. recalls SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.

Some applicator tips from these lots had open seals.

Read the official notice →
Date
2024-05-29
Country
United States
Brand
Ethicon
Product
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Classification
Class II
Units
US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Ethicon recalls

  1. 2024-11-27
  2. US
    Drugs & medicalClass II

    ETHICON, INC. recalls MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or…

    Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

    FDA · DeviceETHICON, INC.U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice →
  3. 2024-11-13
  4. US
    Drugs & medicalClass II

    Ethicon, Inc. recalls Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

    Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

    FDA · DeviceEthicon, Inc.International distribution to the country of China.Official notice →
  5. 2024-06-26
  6. US
    Drugs & medicalClass II

    Ethicon, Inc. recalls PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric…

    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

    FDA · DeviceEthicon, Inc.Worldwide distribution - US Nationwide including PR and the countries of AR,…Official notice →
  7. 2024-04-24
  8. US
    Drugs & medicalClass II

    Ethicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM)…

    Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility

    FDA · DeviceEthicon, Inc.CO GA IA MI NJ NY NY PA SC WIOfficial notice →
  9. 2023-09-27
  10. US
    Drugs & medicalClass II

    ETHICON, LLC recalls PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50,…

    Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

    FDA · DeviceETHICON, LLCUS Nationwide. Global Distribution.Official notice →
  11. 2023-05-17
  12. US
    Drugs & medicalClass II

    Ethicon, Inc. recalls PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft…

    Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

    FDA · DeviceEthicon, Inc.International distribution in the countries of United Kingdom, Ireland and…Official notice →
All 13 Ethicon recalls →

Other drugs & medical recalls in the United States

  1. 2024-05-29
  2. US
    Drugs & medicalClass II

    FUJIFILM Healthcare Americas Corporation recalls Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

    AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).

    FDA · DeviceFUJIFILM Healthcare Americas CorporationUS Nationwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Tornier S.A.S. recalls Stryker Blueprint Software, Catalog #BPUE001.

    The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.

    FDA · DeviceTornier S.A.S.US Nationwide distribution in the states of FL, KY, NJ, and WI.Official notice →
  4. US
    Drugs & medicalClass II

    Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200

    There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.

    FDA · DeviceCadwell Industries IncWorldwide - US Nationwide distribution in the state of MD and the countries of…Official notice →
  5. US
    Drugs & medicalClass II

    Merit Medical Systems, Inc. recalls Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

    Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.

    FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the state of CA and the countries of…Official notice →
  6. US
    Drugs & medicalClass II

    Integra LifeSciences Corp. recalls Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

    Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

    FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of CA, BE, CL.Official notice →
  7. US
    Drugs & medicalClass II

    Philips North America Llc recalls Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144

    Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the…

    FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution.Official notice →
See all drugs & medical recalls →