Drug recall: Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare…

Class II FDA enforcement event 78575. Recall start date: 21 Sep 2017. Status in the FDA record: Terminated. Termination date: 28 Aug 2023.

Reason for recall, in the words of FDA

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

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 Inc started this drug recall on 21 Sep 2017. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 78575 has 68 product records. The first FDA enforcement report date is 7 Feb 2018. The record gives the status Terminated, with the termination date 28 Aug 2023.

FDA enforcement report The 68 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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

Recalling firm

Medline Industries Inc, Northfield, IL.

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

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

Products

68 product records in the event.

FDA event 78575: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0252-2018	Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1	11,750 cases	Class II	Terminated	7 Feb 2018
D-0253-2018	Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093	51 cases	Class II	Terminated	7 Feb 2018
D-0254-2018	Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093	2 cases	Class II	Terminated	7 Feb 2018
D-0255-2018	Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093	5 cases	Class II	Terminated	7 Feb 2018
D-0256-2018	Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093	4 cases	Class II	Terminated	7 Feb 2018
D-0257-2018	Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093	288 cases	Class II	Terminated	7 Feb 2018
D-0258-2018	Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093	21 cases	Class II	Terminated	7 Feb 2018
D-0259-2018	Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093	51 cases	Class II	Terminated	7 Feb 2018
D-0260-2018	Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093	50 cases	Class II	Terminated	7 Feb 2018
D-0261-2018	Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093	375 cases	Class II	Terminated	7 Feb 2018
D-0262-2018	Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	231 cases	Class II	Terminated	7 Feb 2018
D-0263-2018	Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093	1,000 cases	Class II	Terminated	7 Feb 2018
D-0264-2018	Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	65,563 cases	Class II	Terminated	7 Feb 2018
D-0265-2018	Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	10,375 cases	Class II	Terminated	7 Feb 2018
D-0266-2018	Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	14,675 cases	Class II	Terminated	7 Feb 2018
D-0267-2018	Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	11 cases	Class II	Terminated	7 Feb 2018
D-0268-2018	Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	40 cases	Class II	Terminated	7 Feb 2018
D-0269-2018	Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063	40 cases	Class II	Terminated	7 Feb 2018
D-0270-2018	Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093	80 cases	Class II	Terminated	7 Feb 2018
D-0271-2018	Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093	700 cases	Class II	Terminated	7 Feb 2018
D-0272-2018	Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	363 cases	Class II	Terminated	7 Feb 2018
D-0273-2018	Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	280 cases	Class II	Terminated	7 Feb 2018
D-0274-2018	Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	60 cases	Class II	Terminated	7 Feb 2018
D-0275-2018	Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093	80 cases	Class II	Terminated	7 Feb 2018
D-0276-2018	Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	4,100 cases	Class II	Terminated	7 Feb 2018
D-0277-2018	Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	250 cases	Class II	Terminated	7 Feb 2018
D-0278-2018	Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	56 cases	Class II	Terminated	7 Feb 2018
D-0279-2018	Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093	600 cases	Class II	Terminated	7 Feb 2018
D-0280-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	700 cases	Class II	Terminated	7 Feb 2018
D-0281-2018	Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	1100 cases	Class II	Terminated	7 Feb 2018
D-0282-2018	Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060	248 cases	Class II	Terminated	7 Feb 2018
D-0283-2018	Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	80 cases	Class II	Terminated	7 Feb 2018
D-0284-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	1,133 cases	Class II	Terminated	7 Feb 2018
D-0285-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	3800 cases	Class II	Terminated	7 Feb 2018
D-0286-2018	Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060	600 cases	Class II	Terminated	7 Feb 2018
D-0287-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	3,089 cases	Class II	Terminated	7 Feb 2018
D-0288-2018	Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	346 cases	Class II	Terminated	7 Feb 2018
D-0289-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	700 cases	Class II	Terminated	7 Feb 2018
D-0290-2018	Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	550 cases	Class II	Terminated	7 Feb 2018
D-0291-2018	Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	10,298 cases	Class II	Terminated	7 Feb 2018
D-0292-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	100 cases	Class II	Terminated	7 Feb 2018
D-0293-2018	Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093	100 cases	Class II	Terminated	7 Feb 2018
D-0294-2018	Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	1,250 cases	Class II	Terminated	7 Feb 2018
D-0295-2018	Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	3,300 cases	Class II	Terminated	7 Feb 2018
D-0296-2018	Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060	20,430 cases	Class II	Terminated	7 Feb 2018
D-0297-2018	Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093	2,336 cases	Class II	Terminated	7 Feb 2018
D-0298-2018	Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093	350 cases	Class II	Terminated	7 Feb 2018
D-0299-2018	Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464	5,400 cases	Class II	Terminated	7 Feb 2018
D-0300-2018	Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060	90 cases	Class II	Terminated	7 Feb 2018
D-0301-2018	Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline Industries, Inc., Northfield, IL 60093	120 cases	Class II	Terminated	7 Feb 2018
D-0302-2018	Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060	2,369 cases	Class II	Terminated	7 Feb 2018
D-0303-2018	Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060	66 cases	Class II	Terminated	7 Feb 2018
D-0304-2018	Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093	88 cases	Class II	Terminated	7 Feb 2018
D-0305-2018	Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060	149 cases	Class II	Terminated	7 Feb 2018
D-0306-2018	Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093	60 cases	Class II	Terminated	7 Feb 2018
D-0307-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060	49,587 cases	Class II	Terminated	7 Feb 2018
D-0308-2018	Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060	808 cases	Class II	Terminated	7 Feb 2018
D-0309-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060	98,901 cases	Class II	Terminated	7 Feb 2018
D-0310-2018	Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060	195,448 cases	Class II	Terminated	7 Feb 2018
D-0311-2018	Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590	450 cases	Class II	Terminated	7 Feb 2018

The table shows 60 of 68 product records. The FDA enforcement report lists all the records.

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

Drug events that started in 2017: 343
Share of these events in Class II: 57%
Product records in this event: 68Median of the firm: 1
Events of the firm on the register: 61

Other events of the firm

Other FDA enforcement events of Medline Industries Inc
Initiated	Product (first record)	Type	Class	Records
21 Jul 2022	Medline CHEST TUBE REORDER NO: DYNJ36762A	Device	Class II	1
8 Nov 2021	Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC	Drug	Class II	1
27 Oct 2021	EVLP Convenience Pack/Kit	Device	Class II	5
6 Aug 2021	NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Of	Device	Class II	2
1 Jul 2021	Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irr	Device	Class II	4
25 May 2021	Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft a	Device	Class II	1
14 May 2021	READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use O	Drug	Class III	1
30 Apr 2021	Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recov	Device	Class II	1
15 Mar 2021	Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test car	Device	Class II	1
25 Jan 2021	RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglob	Device	Class II	1

Medline Industries Inc: all 61 events

Official channels

FDA enforcement report D-0252-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 78575. https://recallregister.com/fda/ii/78575/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug 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: Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
What quantity of product is in FDA event 78575?: The event has 68 product records. The first record gives this quantity: 11,750 cases
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2017 have the same class?: 57% of the 343 drug events that started in 2017 are in Class II.