CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Centurion- Pelvic Exam Kits DYNDE1037 Pelvic Exam recalled

Centurion Medical Products is recalling Centurion- Pelvic Exam Kits DYNDE1037 Pelvic Exam Tray,University H 2019032090 DYNDE1037, distributed nationwide in the US. The recall was initiated on 11 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 2019032090, 2018091790,

Quantity recalledN/A

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-1050-2020
FDA event ID: 84530
Recalling firm: Centurion Medical Products, Williamston, MI
Classification: Class II
Status: Terminated
Recall initiated: 11 Dec 2019
FDA classified: 5 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

11 Dec 2019	Recall initiated by company
5 Feb 2020	Classified by FDA	+56 days
12 Feb 2020	Published in enforcement report	+7 days

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

Reason for recall

Incomplete seals on the sterile package may compromise the sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790

Where it was distributed

Nationwide Foreign: GHANA

Nationwide

Questions about this recall

Why was it recalled?

Incomplete seals on the sterile package may compromise the sterility

Which lots are affected?

Lot Numbers: 2019032090, 2018091790,

Where was it sold?

Nationwide Foreign: GHANA

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

53 other products · FDA event 84530

This product is part of a recall event; the main page for the event is Centurion- Umbilical Trays UVT1045 Umbilical Artery Tray recalled.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2020	CLASS II	Centurion- Umbilical Trays UVT1045 Umbilical Artery Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- ENT SNUF3 Snuffer KIT Y recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- HT5555A Hyperalimentation & Drsg Chg Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Skin Prep Kits SB1280 Skin Scrub Kit SB1525 recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Dressing Change Tray DT10290S Central Line recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Biopsy Tray TRIBT170 Biopsy Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion Chest Tube Trays: Kit recalled by Centurion Medical Products	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Driveline System Kit TRIDM250 Outpatient recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Umbilical Vessel UPC175 Umbilical Vessel Cath recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- OR2020 Basin SET recalled by Centurion Medical Products	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Vaginal Speculum VS2000LST Sterile ER Vaginal recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Port Draw Kit KNV30 Port Draw Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- LC145 Sterile Nicu Line Change Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Pelvic PE120 Large/Medium Pelvic Tray PE2200 recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Circumcision Tray Kits DYNDF1078C Circumcision recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Blood Culture Collection Kit BP115 Blood Culture recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Trays DYNTray, surgicalJ08835 Debridement Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Uterine Sound 67465 Sterile Sims Uterine Sound recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Trach Kits TC6282G Tracheostomy Care Tray TC7170 recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Dressing Change Kits DYNDC1182B PICC Insertion recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Dressing Tray M101156A Dressing Tray M101167A recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Nasal Speculum NSP500ST Sterile Nasal Speculum recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion IVS3505 Ultrasound Guided Piv Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion Circumsion Trays as follows: Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Pitcher Kit GR100150ST Graduated Pitcher Sterile recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Suture Trays SUT10140 Suture Tray SUT10290 recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Dressing Change Kit BSICVC1005A Cvc Dressing recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Surgical Tray MNS10255 Delivery Tray MNS10255 recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Surgical trays DYNJ04079Z Circumcision Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion Dental Kits DH775 Premium Dental Exam Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Laceration Trays DYNDL1073 Laceration Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- P151659 Biopsy Tray P243133 Latex Tubing Pack recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Skin Prep Trays SP1180 Dry Prep Set SP200 Skin recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Trach Kits TC6282G Tracheostomy Care Tray TC7170 recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Medicine Cup GMC205 Sterile recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Infant Feeding Kit IFK840 Infant Feeding Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- PT225 Pain Management Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Suture Tray DYNDR1210A Suturing Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Skin Prep Tray DYNDP1015 Skin Prep Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion Neonatal PICC Tray recalled by Centurion Medical Products	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- UVT1045 Umbilical Artery Tray UVT1055 Uvc Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Trays EBSI1021 Valve Change Kit- Double recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Incision /Drainage Tray ID1235A Eskenazi Incision recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion PICC : CVI2650 Angio Tray CVI3610 Central Line recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Drive Kits DM1005 Daily Lvad Maintenance Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- I86625 Debridement Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Biopsy Tray BT205A Minor Set UP Biopsy Tray recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-General Surgery Convenience Kits DYNDH1033B recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-_General Surgery Trays DYNDA1127A Radiology Cut recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- Pathology Container 1150ST Sterile Graduated recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Irrigation Kit IG25STSS Irrigation Gun &Valve Set recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020	CLASS II	Centurion-Lvad Kits DM1005 Daily Lvad Maintenance Kit recalled	Centurion Medical Products	Sterility	Nationwide

More recalls from Centurion Medical Products

All 152

Reported	Class	Recall	Company	Reason	Where
15 Jul 2020Device	CLASS II	Centurion Difficult IV KIT containing BD's Vacutainer recalled	Centurion Medical Products	Foreign Material	Nationwide
12 Feb 2020Device	CLASS II	Centurion-Lvad Kits DM1005 Daily Lvad Maintenance Kit recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020Device	CLASS II	Centurion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020Device	CLASS II	Centurion-Irrigation Kit IG25STSS Irrigation Gun &Valve Set recalled	Centurion Medical Products	Sterility	Nationwide
12 Feb 2020Device	CLASS II	Centurion- Pathology Container 1150ST Sterile Graduated recalled	Centurion Medical Products	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide