Device recall: MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101

Class II FDA enforcement event 99960. Recall start date: 9 Sep 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

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 started this device recall on 9 Sep 2026. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 99960 has 13 product records. The first FDA enforcement report date is 28 Oct 2026. The record gives the status Ongoing. 27 of the 697 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.

FDA enforcement report The 13 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 3 Nov 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide and the countries of CA, TC, AU, AE.

Recalling firm

Medline Industries, LP, Northfield, IL.

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

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

Products

13 product records in the event.

FDA event 99960: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0269-2027	MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101	4765 units	Class II	Ongoing	28 Oct 2026
Z-0270-2027	MEDLINE DRAPE C-SEC FEN CLEAR SCRN WIRE, Medline Product Number/SKU DYNJP6106	161 units	Class II	Ongoing	28 Oct 2026
Z-0271-2027	MEDLINE DRAPE C-SECTION FEN CLR SCREEN W, Medline Product Number/SKU DYNJP6108	2569 units	Class II	Ongoing	28 Oct 2026
Z-0272-2027	MEDLINE medical convenience kits labeled as: FETOSCOPY CDS-LF, Medline Product Number/SKU CDS840215P	10 kits	Class II	Ongoing	28 Oct 2026
Z-0273-2027	MEDLINE medical convenience kits labeled as: C-SECTION PACK, Medline Product Number/SKU DYNJ48455A	222 units	Class II	Ongoing	28 Oct 2026
Z-0274-2027	MEDLINE medical convenience kits labeled as: 1) FETAL SURGERY CDS-LF, Medline Kit Number/SKUCDS840214R; 2) MAJOR, Medline Kit Number/SKUDYNJ904851I; 3) ABDOMINAL TRANSPLANT, Medline Kit Number/SKUDYNJ908124B.	233 kits	Class II	Ongoing	28 Oct 2026
Z-0275-2027	MEDLINE medical convenience kits labeled as (list truncated)	26965 kits	Class II	Ongoing	28 Oct 2026
Z-0276-2027	MEDLINE medical convenience kits labeled as: 1) BIRTHDAY KIT-DOUBLE BASIN-LF, Medline Kit Number/SKU DYNJ16127N; 2) NYGH-DELIVERY PACK-LF, Medline Kit Number/SKU DYNJ27206D; 3) OB/GYN, Medline Kit Number/SKU DYNJ911652.	2229 kits	Class II	Ongoing	28 Oct 2026
Z-0277-2027	MEDLINE medical convenience kits labeled as: 1) LAPAROTOMY GYN CDS, Medline Kit Number/SKU CDS983529O; 2) GYN ROBOTIC PK-LF, Medline Kit Number/SKU DYNJ52432M; 3) TAH PACK, Medline Kit Number/SKU DYNJ60646A; 4) TUBAL LIGATION RFD, Medline Kit Number/SKU DYNJ906291F.	545 units	Class II	Ongoing	28 Oct 2026
Z-0278-2027	MEDLINE medical convenience kits labeled as: (list truncated)	146971 kits	Class II	Ongoing	28 Oct 2026
Z-0279-2027	MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G	3 kits	Class II	Ongoing	28 Oct 2026
Z-0280-2027	MEDLINE medical convenience kits labeled as: C-SECTION TRAY-LF, Medline Kit Number/SKU OBN471K	108 kits	Class II	Ongoing	28 Oct 2026
Z-0281-2027	MEDLINE medical convenience kits labeled as: 1) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64103C; 2) HIP SCOPE PACK, Medline Kit Number/SKU DYNJ64155B.	56 kits	Class II	Ongoing	28 Oct 2026

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 2026: 697
Share of these events in Class II: 87%
Product records in this event: 13Median of the firm: 5
Events of the firm on the register: 74

Other events of the firm

Other FDA enforcement events of Medline Industries, LP
Initiated	Product (first record)	Type	Class	Records
11 Sep 2026	Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A	Device	Class II	1
2 Sep 2026	Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D	Device	Class II	12
31 Aug 2026	Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN	Device	Class II	6
14 Aug 2026	Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MD	Device	Class I	2
14 Aug 2026	Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purp	Device	Class II	2
11 Aug 2026	Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A	Device	Class I	7
10 Aug 2026	Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and Sinus Pack DYNJ4825	Device	Class II	2
10 Aug 2026	Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J	Device	Class II	5
31 Jul 2026	Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A	Device	Class II	4
23 Jul 2026	Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N	Device	Class II	1

Medline Industries, LP: all 74 events

Official channels

FDA enforcement report Z-0269-2027The 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 99960. https://recallregister.com/fda/ii/99960/. Source: openFDA enforcement reports. Data through 3 Nov 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 3 Nov 2026
Newest FDA report date on the register: 28 Oct 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 CA, TC, AU, AE.
What quantity of product is in FDA event 99960?: The event has 13 product records. The first record gives this quantity: 4765 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 697 device events that started in 2026 are in Class II.