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 |
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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.
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