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 .
Read the official notice →- Date
- 2024-06-26
- Country
- United States
- Brand
- Ethicon
- Product
- PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide including PR and the countries of AR,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2025-02-12
USEthicon, LLC recalls PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue…
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and…
FDA · DeviceEthicon, LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2024-11-27
- US
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 → - 2024-11-13
- US
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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.
- 2024-05-29
- US
Ethicon, Inc. recalls SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Some applicator tips from these lots had open seals.
FDA · DeviceEthicon, Inc.US Nationwide distribution in the states of AR, CA, FL, GA, ID, IL, IN, KY,…Official notice → - 2024-04-24
- US
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
- 2023-09-27
- US
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.
Other drugs & medical recalls in the United States
- 2024-06-26
- US
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