Ethicon Recalls PDS Plus Antibacterial Sutures for Tensile Strength Defects
Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications. The affected products were distributed in Japan.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (tensile strength) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures, specifically the PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle (Product Code: PDP493G, GTIN 10705031203945). The recall is being conducted because the products do not meet a tensile strength specification.
The affected units are identified by Lot Number MCZ162. According to the source data, these products were distributed in Japan.
Consumers and healthcare providers should stop using the affected suture units and contact Ethicon, Inc. for further instructions or a replacement.
The recalled product
- Product
- PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 756
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number:MCZ162
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Ethicon, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Ethicon, Inc.
See all →- HighEthicon Recalls Monocryl Sutures Due to Component Mix-Up
FDA (Devices) · 2024-11-27
- HighCoated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
FDA (Devices) · 2024-11-13
- HighPDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
- HighPDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
- HighMONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
FDA (Devices) · 2024-06-26
Same hazard · structural defect
See all →- SevereSubaru Recalls 2026 Forester and Crosstrek for Ball Joint Defect
NHTSA · 2026-10-19
- Severe
- SevereVolvo Recalls 2025-2026 VNL Trucks for Loose Structural Bolts
NHTSA · 2026-10-15
- Severe
- Severe
Similar recalls
- HighPDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect
FDA (Devices) · 2023-09-27
- ModerateEthicon Recalls PDS Plus Sutures Due to Incorrect Expiry Date Labeling
FDA (Devices) · 2018-04-18
- ModerateEthicon Recalls PDS Plus Antibacterial Sutures Due to Incorrect Expiry Dates
FDA (Devices) · 2018-04-18
- ModerateEthicon Recalls STRATAFIX Spiral PDS Plus Violet Sutures
FDA (Devices) · 2019-10-16
- HighPDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
- ModerateEthicon Recalls Three Stratafix Suture Units for Internal Testing Failures
FDA (Devices) · 2020-02-26