Recall Register

Device recall: Centurion STERILE TRACH BRUSH, Product Code 6225ST

Class II FDA enforcement event 94136. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

MEDLINE INDUSTRIES, LP - Northfield started this device recall on 23 Feb 2024. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 94136 has 29 product records. The first FDA enforcement report date is 10 Apr 2024. The record gives the status Ongoing.

FDA enforcement reportThe 29 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

29 product records in the event.

FDA event 94136: product records
Recall numberProductQuantityClassStatusReport date
Z-1427-2024Centurion STERILE TRACH BRUSH, Product Code 6225ST1700Class IIOngoing10 Apr 2024
Z-1428-2024Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575480 unitsClass IIOngoing10 Apr 2024
Z-1429-2024Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6100 unitsClass IIOngoing10 Apr 2024
Z-1430-2024Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product Code 6430ST1350 unitsClass IIOngoing10 Apr 2024
Z-1431-2024Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH7602310 unitsClass IIOngoing10 Apr 2024
Z-1432-2024Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product Code 67830100 unitsClass IIOngoing10 Apr 2024
Z-1433-2024Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505440 unitsClass IIOngoing10 Apr 2024
Z-1434-2024Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535760 unitsClass IIOngoing10 Apr 2024
Z-1435-2024Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product Code 66660; b) STERILE SMALL 2 PRONG SKIN HOOK (25754), Product Code 67105; c) STERILE NEWS TRACH HOOK(83300), Product Code 67810; d) STERILE LILLIE EAR HOOK DELICATE 7", Product Code I686551520 unitsClass IIOngoing10 Apr 2024
Z-1436-2024Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I682903860 unitsClass IIOngoing10 Apr 2024
Z-1437-2024Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), Product Code 66165; b) STERILE WEBSTER NEEDLEHOLDER, Product Code 66185; c) STERILE ADSON FORCEP SERR (598), Product Code 66195; d) STERILE DRESSING FORCEP SERR (DF6003), Product Code 66200; e) STERILE TISSUE FORCEP W/TEETH (TF6015), Product…274410 unitsClass IIOngoing10 Apr 2024
Z-1438-2024Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175; e) STERILE CURV SATIN HEMOSTAT (MHS103S),…80903 unitsClass IIOngoing10 Apr 2024
Z-1439-2024Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970; e) ST BUCK EAR CURETTE BLNT STR SZ 00,…20614 unitsClass IIOngoing10 Apr 2024
Z-1440-2024Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWEL CLAMPS 5 1/2", Product Code I68095; f) ZIPSER…12980 unitsClass IIOngoing10 Apr 2024
Z-1441-2024Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE NAIL NIPPER, Product Code 67110; f) STERILE…60075 unitsClass IIOngoing10 Apr 2024
Z-1442-2024Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6" (SF8246), Product Code 66580; b) DEBRIDEMENT TRAY, Product Code I86630; c) BIOPSY INSTRUMENT PACK, Product Code I86690; d) DEBRIDEMENT TRAY, Product Code I86815; e) IR ADSON FORCEP & NEEDLE HOLDER, Product Code MNS12675; f) TOENAIL REMOVAL…7950 unitsClass IIOngoing10 Apr 2024
Z-1443-2024Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT213551335 unitsClass IIOngoing10 Apr 2024
Z-1444-2024Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150; e) STERILE STRT IRIS SCISSOR (IS163),…568,849 unitsClass IIOngoing10 Apr 2024
Z-1445-2024Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUTURE REMOVAL KIT, Product Code SR60555; d) SKIN…23,290 unitsClass IIOngoing10 Apr 2024
Z-1446-2024Centurion STERILE #16 RUBBER BAND, Product Code EB16150 unitsClass IIOngoing10 Apr 2024
Z-1447-2024Centurion PICC LINE SECUREMENT KIT, Product Code IVS565300 unitsClass IIOngoing10 Apr 2024
Z-1448-2024Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST1700 unitsClass IIOngoing10 Apr 2024
Z-1449-2024Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f)…84224 unitsClass IIOngoing10 Apr 2024
Z-1450-2024Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE…270 unitsClass IIOngoing10 Apr 2024
Z-1451-2024Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 673351350 unitsClass IIOngoing10 Apr 2024
Z-1452-2024MEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582A4200 unitsClass IIOngoing10 Apr 2024
Z-1453-2024MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA27242458 unitsClass IIOngoing10 Apr 2024
Z-1454-2024MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006800 unitsClass IIOngoing10 Apr 2024
Z-1455-2024MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA27230Class IIOngoing10 Apr 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024
970
Share of these events in Class II
87%
Product records in this event
29Median of the firm: 2
Events of the firm on the register
120

Other events of the firm

Other FDA enforcement events of MEDLINE INDUSTRIES, LP - Northfield
InitiatedProduct (first record)TypeClassRecords
25 Jul 2025Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRDeviceClass I2
23 Jul 2025Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DeviceClass II1
14 Jul 2025Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH,DeviceClass I1
8 Jul 2025The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utiliDeviceClass II1
7 Jul 2025Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, ManufDrugClass II6
16 Jun 2025SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301DeviceClass II1
12 Jun 2025Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564DeviceClass II4
23 May 2025Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER DeviceClass II3
15 May 2025Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250DeviceClass II1
22 Apr 2025Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS98DeviceClass I3

MEDLINE INDUSTRIES, LP - Northfield: all 120 events

Official channels

Cite this page

Recall Register. FDA enforcement event 94136. https://recallregister.com/fda/ii/94136/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Worldwide distribution - US Nationwide and the countries of Panama, Canada.
What quantity of product is in FDA event 94136?
The event has 29 product records. The first record gives this quantity: 1700
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?
87% of the 970 device events that started in 2024 are in Class II.