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Smith & Nephew Medical Ltd FDA Inspection Record

FEI 3002808194 · Inspections, Form 483s, warning letters and import refusals

Smith & Nephew Medical Ltd is an FDA-registered facility (FEI 3002808194) located in HULL East Riding of Yorkshire, GB. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Jul 9, 2015: No Action Indicated (NAI)
Inspections on record
1 (1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
2, latest Oct 2, 2024
Import refusals
5

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jul 9, 2015No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Quality audits - Lack of or inadequate procedures (21 CFR 820.22)
Report of Death or Serious Injury (21 CFR 803.50(a)(1))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 2, 2024Class IIZ-0516-2025RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a…
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Mar 11, 2024Class IIZ-1596-2024RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from… and 1 more product
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

FDA record score

5 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

2 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-0516-2025, this FEI as the recalling firmOct 2, 20244 x 0.62.4
Class II recall Z-1596-2024, this FEI as the recalling firmMar 11, 20244 x 0.62.4

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Smith & Nephew Medical, Ltd.
Location
HULL East Riding of Yorkshire (GB)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.