CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report

Dover Kit/Sterile Preserve Cult recalled by Covidien

Covidien is recalling Dover Kit/Sterile Preserve Cult, distributed nationwide in the US. The recall was initiated on 22 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Codes: 510450164X 524350264X

Quantity recalled10,000

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1203-2016
FDA event ID: 73121
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 22 Jan 2016
FDA classified: 21 Mar 2016
Reported: 30 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

22 Jan 2016	Recall initiated by company
21 Mar 2016	Classified by FDA	+59 days
30 Mar 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Product as listed by the FDA

Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients

Where it was distributed

US (nationwide) and to Canada.

Nationwide

Questions about this recall

Why was it recalled?

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

Which lots are affected?

Lot Codes: 510450164X 524350264X

Where was it sold?

US (nationwide) and to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

33 other products · FDA event 73121

This product is part of a recall event; the main page for the event is Dover PREM U/M TMP SNS CSD recalled by Covidien.

Reported	Class	Recall	Company	Reason	Where
30 Mar 2016	CLASS II	Dover PREM U/M TMP SNS CSD recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 Prem U/M Slvr Fly recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Pprem UL Ltx Foley Try Csd recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 Prem U/M Sil Coude Cath Secure recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover 400 Prem U/M Slvr Fly recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 Prem U/M UL Foly Csd recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 Prem U/M Sil Coude Cath Secure recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Precsion PRM SIL FLY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Precision Prm Sil Coude Cath Secure recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Prec Prm Silver Fly TY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 UM Sil Coude Secure recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Midstream W/Cast Soap recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Easy Catch Midstream KT W/Cast recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 UM Sil Coude Secure recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 PREM U/M TMP SNS CSD recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Prec Prm Silver Fly TY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 PREM U/M SIL FLY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Midstream W/Castile Towl recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 Prem U/M UL Foly Csd recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 PREM U/M SIL FLY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Midstream Kit Ring Castile recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Precision Prm Sil Coude Cath Secure recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover ¿/CH Silver-hydrogel Coated Silicone Foley Catheter recalled	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Precsion PRM SIL FLY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Prem UL Ltx Foley Try Csd recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover PREM U/M SIL FLY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Prem U/M Slvr Fly recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover P400 Prem UM Silv Tmp Csd recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Prec Prm Silver Fly TY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Catch Kit Soap recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Precsion PRM SIL FLY recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Midstream Kit Castile Soap recalled by Covidien	Covidien	Other	Nationwide
30 Mar 2016	CLASS II	Dover Midstream Kit Castile Soap recalled by Covidien	Covidien	Other	Nationwide

More recalls from Covidien

All 493

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	EndoFLIP System that includes recalled by Covidien	Covidien	Other	Nationwide
19 Aug 2026Device	CLASS II	Dermalon 88861757-31 Dermalon* 4-0 Blu C13 recalled by Covidien	Covidien	Sterility	Nationwide
19 Aug 2026Device	CLASS II	Surgipro SP-623 Surgipro* 2-0 BLU SC2 X36 SP recalled by Covidien	Covidien	Sterility	Nationwide
19 Aug 2026Device	CLASS II	V-Loc 90 Absorbable Wound Closure Device Vloc 90 0 VL recalled	Covidien	Sterility	Nationwide
19 Aug 2026Device	CLASS II	Surgipro II S8698GX Surgipro II BL 5/0 18 P-13 S8698GX recalled	Covidien	Sterility	Nationwide

Other Test Kits & Diagnostics recalls

All 2,656

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	Syva EMIT 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide
26 Aug 2026Device	CLASS II	Beckman Coulter, Emit 2000 Quinidine Assay recalled	Siemens Healthcare Diagnostics	Potency & Assay	Nationwide