Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-...

FDA Device Recall #Z-2118-2015 — Class II — April 16, 2015

Recall Summary

Recall Number Z-2118-2015
Classification Class II — Moderate risk
Date Initiated April 16, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Covidien LLC
Location North Haven, CT
Product Type Devices
Quantity 385486

Product Description

Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA2006 NON STERILE SUBASSEMBLY SA2007 NON STERILE SUBASSEMBLY SA2008 SA-7457-R NS SUBASSEMBLY SA2032B NSSA SA2038A NSSA SA2042 SA2042 SUBASSEMBLY NS SA2049 SA2049 NON STERILE SUBASSEMBLY SA2058B NSSA SA2074 SA2074 NON STERILE SUBASSEMBLY SA2075 SA2075 NON STERILE SUBASSEMBLY SA2109 SA2109 NON STERILE SUBASSY SA2119 SA2119 NON STERILE SUBASSY SA2120 SA2120 NON STERILE SUBASSY SA2121 NON STERILE SUBASSY SA2122 SA2122 NON STERILE SUBASSY SA2164A NSSA SA2172A NSSA SA2172B NSSA SA2173C NSSA SA2174B NSSA SA2185 SRM800 NSSA SA2198D NSSA SA2199 SA2199 NON STERILE SUBASSY SA2219 NSSA SA3011 SA3011 NON STERILE SUBASSY SA3013 SA3013 NON STERILE SUBASSY SA3018 SA3018 NON STERILE SUBASSY SA3040 SA3040 NON STERILE SUBASSY SA3045 NSSA SA3060 SA3060 NON STERILE SUBASSY SA3062A NSSA SUBASSEMBLY SA3068 SA3068 NON STERILE SUBASSY SA3069 SA3069 NON STERILE SUBASSY SA3071 SA3071 NON STERILE SUBASSY SA3076 NSSA SA3076A NSSA SA3077 NSSA BUTTON SA3078 NSSA ROCKER SA3080 NSSA SA4003 NON STERILE SUBASSEMBLY SA4003A NON STERILE SUBASSEMBLY SA4013 NSSA SA4014 NSSA SA4015 NSSA SA5006 NSSA SA5015 NSSA SA5017 NON STERILE SUBASSEMBLY SA2140 SA2140 NON STERILE SUBASSY

Reason for Recall

Devon Light Gloves contain splits or holes compromising the sterility

Distribution Pattern

Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and UAE.

Lot / Code Information

Lot number begins 508xxxx or lower

Other Recalls from Covidien LLC

Recall # Classification Product Date
Z-1557-2026 Class II HealthCast "Vital Sync" Remote Patient Monitori... Jan 30, 2026
Z-1775-2022 Class II Puritan Bennett 560 Ventilator, PB560, CFN 4096600 Aug 19, 2022
Z-1318-2022 Class I Palindrome SI Chronic Catheter, Sterile, Single... Jun 8, 2022
Z-1319-2022 Class I Palindrome HSI Chronic Catheter, Sterile, Singl... Jun 8, 2022
Z-1315-2022 Class I Palindrome Precision HSI Chronic Catheter, Ster... Jun 8, 2022

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Covidien LLC Recalls by Firm Recall Reasons Device Safety Stats