CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

Medline surgical convenience kits labeled as: EAR recalled

Medline Industries is recalling Medline surgical convenience kits labeled as: EAR, Medline product number, distributed nationwide in the US. The recall was initiated on 2 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 26AMF311; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25JMD500; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25DMJ849; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25CMD823; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25BMG250; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 24LMG633; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24KMB736; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24JMD634; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24IMD605; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBT243; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBD143; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24GMG103; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24DMI379; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24CBJ928; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24BME929; Medline product number/SKU DYNJ65706, UDI/DI 10193489284904 (each) 40193489284905 (case), Lot number 24AMF210; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24AMD338; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LME666; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LMB230; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMF895; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMD188; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23HMH838; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23HBG421; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23FBD203; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23EBL260; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23CMB011; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23CBU833; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBV592; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBJ850; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22ABL217; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21LBM269; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21HBC597; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21GBE864; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21FBJ082.

Quantity recalled620 kits

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-0173-2027
FDA event ID: 99886
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 2 Sep 2026
FDA classified: 15 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

2 Sep 2026	Recall initiated by company
15 Oct 2026	Classified by FDA	+43 days
21 Oct 2026	Published in enforcement report	+6 days

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

Reason for recall

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4) EAR, Medline product number/SKU DYNJ909020; 5) FEM CAROTID PACK, Medline product number/SKU DYNJ65706; 6) CAROTID CDS-LF, Medline product number/SKU CDS983139B.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Which lots are affected?

Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 26AMF311; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25JMD500; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25DMJ849; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25CMD823; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 25BMG250; Medline product number/SKU DYNJ909020B, UDI/DI 10198459159213 (each) 40198459159214 (case), Lot number 24LMG633; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24KMB736; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24JMD634; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24IMD605; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBT243; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24HBD143; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24GMG103; Medline product number/SKU DYNJ909020A, UDI/DI 10195327665760 (each) 40195327665761 (case), Lot number 24DMI379; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 24CBJ928; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24BME929; Medline product number/SKU DYNJ65706, UDI/DI 10193489284904 (each) 40193489284905 (case), Lot number 24AMF210; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 24AMD338; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LME666; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23LMB230; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMF895; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23KMD188; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23HMH838; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23HBG421; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23FBD203; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23EBL260; Medline product number/SKU DYNJ909020, UDI/DI 10195327248673 (each) 40195327248674 (case), Lot number 23CMB011; Medline product number/SKU DYNJ42922C, UDI/DI 10193489335019 (each) 40193489335010 (case), Lot number 23CBU833; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBV592; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22BBJ850; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 22ABL217; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21LBM269; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21HBC597; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21GBE864; Medline product number/SKU CDS983139B, UDI/DI 10193489211313 (each) 40193489211314 (case), Lot number 21FBJ082.

Where was it sold?

US Nationwide distribution.

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 27 Oct 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

9 other products · FDA event 99886

This product is part of a recall event; the main page for the event is Medline surgical convenience kits labeled as: Open Heart recalled.

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as: Open Heart recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as: Spinal CDS recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Product Name Aud Open Heart Pack, Medline Kit Number recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide

More recalls from Medline Industries

All 726

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Product Name Aud Open Heart Pack, Medline Kit Number recalled	Medline Industries	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,902

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Scout MD recalled by Merit Medical Systems	Merit Medical Systems	Other	7 states
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Perma-hand Silk Black Braided Sterile Nonabsorbable recalled by Ethicon	Ethicon	Packaging Defects	Nationwide