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MEDLINE INDUSTRIES, INC.

United States·US-MF-000009717

Last updated May 24, 2026

Information

Country: United States
Address: Three Lakes Drive, Northfield, United States
Website: medline.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)633-5463
PRRC Contact: Pahola Vasquez
EUDAMED SRN: US-MF-000009717
FDA FEI Number: —
DUNS Number: 025460908

Catalogue (250021)

Page 1 of 500

Device	Model / Reference	Registries	Class	Status
Hudson RCI, Aquapak	H00040CE	EUDAMED	Class IIa	Active
Comfort Glide	CGSHEETRXL	EUDAMED	Class I	Active
Ornex + Med-Stop	ORNEX66VCA	EUDAMED	Class I	Active
Comfort Glide	CGWEDGE-RXL	EUDAMED	Class I	Active
Medline Industries, Inc.	DYNJ55209	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ46330C	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ0780009N	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ53822	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ900807C	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ52926A	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ43808C	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ52451	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ45515A	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ9717153R	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ47733	FDA UDI	Class II	Active
Medline Industries, Inc.	BMH03OML	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ16027F	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ27589C	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ14231C	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ908875F	FDA UDI	Class II	Active
Medline Industries, Inc.	CDS984660N	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ82317D	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ34420P	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ905311K	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ48098F	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ69838D	FDA UDI	Class II	Active
Medline	ECVC5700	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ35678D	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ44593A	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ903866A	FDA UDI	Class II	Active
Medline	DYNJAETC85S	FDA UDI	Class II	Active
Medline	5310306RH	FDA UDI	Class I	Active
Medline	5091122R	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ47164	FDA UDI	Class II	Active
Medline	31068RH	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNDL1595A	FDA UDI	Class I	Active
Medline	DYNDJ1055	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ45944A	FDA UDI	Class II	Active
Medline Industries, Inc.	DYKM1255	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ900755D	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ0392258M	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ0805062F	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ0299312B	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ66322C	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ0468381N	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ900045D	FDA UDI	Class II	Active
Medline Industries, Inc.	DYNJ67608	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ63211A	FDA UDI	Class I	Active
Medline Industries, Inc.	DYNJ65575	FDA UDI	Class II	Active
Medline	MNS11800	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Medline International France FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 27, 2021	Z-0360-2022	—	terminated	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Oct 27, 2021	Z-0358-2022	—	terminated	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Oct 27, 2021	Z-0359-2022	—	terminated	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Oct 27, 2021	Z-0362-2022	—	terminated	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Oct 27, 2021	Z-0361-2022	—	terminated	NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Aug 6, 2021	Z-2575-2021	—	terminated	Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Aug 6, 2021	Z-2574-2021	—	terminated	Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Jul 1, 2021	Z-2232-2021	—	terminated	The kits may contain an expired component.
Jul 1, 2021	Z-2234-2021	—	terminated	The kits may contain an expired component.
Jul 1, 2021	Z-2233-2021	—	terminated	The kits may contain an expired component.
Jul 1, 2021	Z-2231-2021	—	terminated	The kits may contain an expired component.
May 25, 2021	Z-2080-2021	—	terminated	Potential for mold contamination (Aspergillus vadensis)
Apr 30, 2021	Z-1841-2021	—	open, classified	The devices may not meet the minimum required sterility assurance level.
Mar 15, 2021	Z-1407-2021	—	open, classified	Possible false negative or false positive results due to the product being compromised during shipment.
Jan 25, 2021	Z-1249-2021	—	terminated	Product was compromised during shipment.
Jan 15, 2021	Z-1135-2021	—	terminated	Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
Nov 13, 2020	Z-0782-2021	—	terminated	The cylindrical sponge component is not x-ray detectable.
Nov 13, 2020	Z-0780-2021	—	terminated	The cylindrical sponge component is not x-ray detectable.
Nov 13, 2020	Z-0779-2021	—	terminated	The cylindrical sponge component is not x-ray detectable.
Nov 13, 2020	Z-0783-2021	—	terminated	The cylindrical sponge component is not x-ray detectable.
Nov 13, 2020	Z-0781-2021	—	terminated	The cylindrical sponge component is not x-ray detectable.
Nov 5, 2020	Z-0615-2021	—	terminated	RevMedX Trauma Dressing is being recalled due to package seal integrity.
Oct 1, 2020	Z-0297-2021	—	terminated	Product compromised during shipment.
Sep 15, 2020	Z-0055-2021	—	open, classified	The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Sep 14, 2020	Z-0067-2021	—	terminated	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sep 14, 2020	Z-0062-2021	—	terminated	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sep 14, 2020	Z-0065-2021	—	terminated	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sep 14, 2020	Z-0066-2021	—	terminated	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sep 14, 2020	Z-0063-2021	—	terminated	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sep 14, 2020	Z-0068-2021	—	terminated	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sep 14, 2020	Z-0061-2021	—	terminated	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sep 14, 2020	Z-0064-2021	—	terminated	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sep 1, 2020	Z-0058-2021	—	terminated	There have been reports of the suction catheter coming apart from the device assembly during use.
Aug 12, 2020	Z-3013-2020	—	terminated	Potential of incomplete seals impacting the sterility of the kit.
Jul 28, 2020	Z-3054-2020	—	terminated	Product was shipped with refrigeration (ice) instead of frozen (dry ice).
Jul 9, 2020	Z-2766-2020	—	terminated	Potential risk of brush detachment during cleaning.
Jun 30, 2020	Z-2725-2020	—	open, classified	There are reports of the suction catheter coming apart from the device assembly during use.
Jun 30, 2020	Z-2724-2020	—	open, classified	There are reports of the suction catheter coming apart from the device assembly during use.
Mar 9, 2020	Z-2040-2020	—	terminated	Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
Feb 10, 2020	Z-1546-2020	—	terminated	Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
Feb 10, 2020	Z-1544-2020	—	terminated	Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
Feb 10, 2020	Z-1545-2020	—	terminated	Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
Jan 21, 2020	Z-1357-2020	—	terminated	The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
Jan 21, 2020	Z-1358-2020	—	terminated	The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
Jan 7, 2020	Z-0865-2020	—	terminated	There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
Oct 30, 2019	Z-0698-2020	—	open, classified	The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit.
Sep 18, 2019	Z-0513-2020	—	terminated	Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.
Sep 6, 2019	Z-2756-2019	—	open, classified	The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.
Aug 9, 2019	Z-2358-2019	—	open, classified	Samples in the identified lot were found to have incomplete or open packaging seals.
May 30, 2019	Z-1984-2019	—	open, classified	The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.
May 28, 2019	Z-2044-2020	—	terminated	Loose silicone particulate was found to be present on the shaft of the silicone catheters.
May 28, 2019	Z-2042-2020	—	terminated	Loose silicone particulate was found to be present on the shaft of the silicone catheters.
May 28, 2019	Z-2043-2020	—	terminated	Loose silicone particulate was found to be present on the shaft of the silicone catheters.
May 10, 2019	Z-2067-2019	—	terminated	This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment which directly impacts amount of occlusion force necessary to fully seal the tube. This defect prevents the pump from complete occlusion and results in the potential for over-infusion of drug product into the patient.
May 3, 2019	Z-2066-2019	—	terminated	The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients due to the incomplete occlusion caused by variation in tubing wall thickness.
Apr 25, 2019	Z-2203-2019	—	terminated	Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
Jan 31, 2019	Z-0174-2020	—	open, classified	Potential for the Semi-Rigid canister lid to fragment during use.
Aug 30, 2018	Z-0088-2019	—	terminated	Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
Jun 15, 2018	Z-3210-2018	—	terminated	There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
Apr 24, 2018	Z-1933-2018	—	terminated	The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Apr 24, 2018	Z-1934-2018	—	terminated	The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Apr 24, 2018	Z-1936-2018	—	terminated	The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Apr 24, 2018	Z-1931-2018	—	terminated	The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Apr 24, 2018	Z-1935-2018	—	terminated	The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Apr 24, 2018	Z-1932-2018	—	terminated	The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Feb 1, 2018	Z-2948-2018	—	terminated	Packaged with an incorrect overwrap.
Jan 12, 2018	Z-2378-2018	—	terminated	One of the cases of product might not have been sterilized.
Oct 23, 2017	Z-0162-2018	—	terminated	Possible open seal on top portion of the package. Could cause breach of sterility.
Oct 10, 2017	Z-0113-2018	—	terminated	Products labeled as sterile were distributed prior to sterilization
Oct 10, 2017	Z-0112-2018	—	terminated	Products labeled as sterile were distributed prior to sterilization
Aug 10, 2017	Z-0164-2018	—	terminated	The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
Aug 10, 2017	Z-0163-2018	—	terminated	The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
Jul 18, 2017	Z-0295-2018	—	terminated	Product did not undergo correct sterilization procedures and may potentially be non-sterile.
Apr 12, 2017	Z-2977-2018	—	terminated	Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.
Apr 12, 2017	Z-2979-2018	—	terminated	Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.
Apr 12, 2017	Z-2980-2018	—	terminated	Multiple surgical packs were assembled with a non-sterile CHG applicators labeled as "ChloraPrep" (kit component numbers: 29183, 52115, 82279, and 82281). The non-sterile components 29183, 52115, 82279, and 82281 should have been placed inside the sterile portion of the pack, where it would subsequently be exposed to the ethylene oxide sterilization process. However, the components were not placed in the sterile portion of the pack during assembly and were never exposed to the sterilization process. Components 29183, 52115, 82279, and 82281 were inadvertently released non-sterile. The remainder of the pack components were properly sterilized and only components 29183, 52115, 82279, and 82281 were affected. Components 29183, 52115, 82279, and 82281 are manufactured by Becton, Dickinson (BD) and are labeled "ChloraPrep". ChloraPrep" applicators contain 2% w/v chlorhexidine gluconate (CHG) in 70% v/v isopropyl alcohol (IPA). The applicators are used to facilitate skin preparation for various preoperative and pre-injection procedures.
Apr 12, 2017	Z-2976-2018	—	terminated	Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.
Apr 12, 2017	Z-2978-2018	—	terminated	One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.
Dec 14, 2016	Z-2105-2017	—	terminated	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
Dec 14, 2016	Z-2107-2017	—	terminated	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
Dec 14, 2016	Z-2106-2017	—	terminated	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
Dec 14, 2016	Z-2104-2017	—	terminated	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
Dec 14, 2016	Z-2103-2017	—	terminated	Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
Nov 23, 2016	Z-1074-2017	—	terminated	Medline Industries, Inc is recalling Unna Z Unna Boot Bandage 3X10 and Unna Z Unna Boot Bandage 4X10 due to contamination of the products with common mold (Cladosporium sphaerospermum/cladosporioides/herbarum/phaenocomae/halotolerans and Penicillium corylophilum)..
Aug 10, 2016	Z-0352-2017	—	terminated	Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
May 11, 2016	Z-2404-2016	—	terminated	There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup has the correct mL markings for the other gradations, but sequentially, the markings are listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL.
Aug 3, 2015	Z-2458-2015	—	terminated	The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
Jul 8, 2015	Z-2433-2015	—	terminated	Charging base of surgical clippers overheats and smokes.
Mar 20, 2014	Z-1649-2014	—	terminated	This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.
Nov 4, 2013	Z-1612-2014	—	terminated	There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens.
Aug 14, 2013	Z-1051-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1048-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1054-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1049-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1050-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1046-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1047-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1056-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1052-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Aug 14, 2013	Z-1055-2014	—	terminated	Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.