Smith & Nephew, Inc. Endoscopy Division

Complete recall history across all FDA and CPSC categories — 37 total recalls

Smith & Nephew, Inc. Endoscopy Division appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (37)

FDA medical device enforcement actions by Smith & Nephew, Inc. Endoscopy Division

Date Product Reason Class
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Co... Sterility of device is compromised due to breach in sterile barrier Class II
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 722038... Sterility of device is compromised due to breach in sterile barrier Class II
Jun 2, 2014 SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, f... Sterility of device is compromised due to breach in sterile barrier Class II
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 722... Sterility of device is compromised due to breach in sterile barrier Class II
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fast... Sterility of device is compromised due to breach in sterile barrier Class II
Aug 6, 2013 TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part ... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (b... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Par... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 ... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue;... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 BIORAPTOR 2.9 mm Suture Anchor with DURABRAID" Suture; Part Number: 72200783 ... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 7220077... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX Ultra HA 6.5 mm with 2 ULTRABRAID Suture, Blue / Black; Part Number: ... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 ... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 BIORAPTOR 2.9 mm Suture Anchor, pack of 1 ULTRABRAID Suture: 72200689 Biod... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 BIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 7220077... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / ... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black;... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX ULTRA PLLA/HA 5.5 mm Suture Anchor with 3 ULTRABRAID Suture: Part Num... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; P... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX" Ultra PLLA/HA 6.5 mm with 2 ULTRABRAID" Suture, White / Black: Part ... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; P... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Par... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (bl... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Par... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 BIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Nu... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Numbe... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Aug 6, 2013 OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Par... Pinholes detected in a small number of primary pouches that may constitute a ... Class II
Jul 14, 2012 Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECU... Devices labeled with an expiry period of 48 months instead of 36 months; an a... Class II
Jul 14, 2012 Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Nu... Device labeled with an expiry period of 48 months instead of 36 months; an ad... Class II
Jul 3, 2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID s... Distal part of the anchor may break on insertion into bone during surgery Class II
Jul 3, 2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-bl... Distal part of the anchor may break on insertion into bone during surgery Class II
Jul 3, 2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBR... Distal part of the anchor may break on insertion into bone during surgery Class II
Jul 3, 2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, C... Distal part of the anchor may break on insertion into bone during surgery Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.