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Owens & Minor Distribution, Inc.

FDA Regulatory Profile

Owens & Minor Distribution, Inc. has 8 FDA recalls, 29 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Owens & Minor Distribution, Inc." and its spelling variant "Owens And Minor Distribution".

Latest recall
Z-1059-2023 · Class III · Jan 3, 2023
Latest inspection
Jul 15, 2026 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls8Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections29Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Owens & Minor Distribution, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Owens & Minor Distribution, Inc.: FDA inspections per year 2017: 5 inspections520172018: 0 inspections020182019: 2 inspections220192020: 2 inspections220202021: 2 inspections220212022: 3 inspections320222023: 4 inspections420232024: 1 inspections120242025: 1 inspections120252026: 2 inspections22026
YearInspectionsOAIWarning lettersRecall recordsClass I
202620000
202510000
202410000
202340010
202230010
202120000
202020000
201920000
201800000
201750000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

8 recall records from Mar 26, 2013 to Jan 3, 2023.

NumberClassProductDate
Z-1059-2023Class IIIFLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround…Jan 3, 2023
Z-0343-2023Class IIAero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734Oct 31, 2022
Z-0888-2017Class IIMedi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15…Oct 31, 2016
Z-0733-2016Class IIMediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per…Nov 17, 2015
Z-0735-2016Class IIMediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per…Nov 17, 2015
Z-0734-2016Class IIMediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per…Nov 17, 2015
Z-0416-2015Class IIMediChoice Dual-Release Folding Walker with 5" wheelJun 25, 2014
Z-1192-2013Class IIMediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001…Mar 26, 2013

Recent FDA inspections

29 inspections from Apr 13, 2010 to Jul 15, 2026. Showing the 20 most recent. View all 29 inspections

DateSiteProductClassificationFEI
Jul 15, 2026Kansas City, MOFood/CosmeticsNo Action Indicated (NAI)2000000369
Jan 9, 2026Saint Paul, MNFood/CosmeticsNo Action Indicated (NAI)1000116185
Oct 6, 2025Morgantown, WVFood/CosmeticsNo Action Indicated (NAI)3036002406
Apr 24, 2024Granite City, ILFood/CosmeticsNo Action Indicated (NAI)3004323091
May 23, 2023Cleveland, OHFood/CosmeticsNo Action Indicated (NAI)3010044066
May 18, 2023Gainesville, FLFood/CosmeticsNo Action Indicated (NAI)3010057947
May 9, 2023Albuquerque, NMFood/CosmeticsNo Action Indicated (NAI)3004670091
Apr 25, 2023Tulsa, OKFood/CosmeticsNo Action Indicated (NAI)3004322793
Oct 31, 2022Grimes, IAFood/CosmeticsNo Action Indicated (NAI)3010058080
Mar 9, 2022Wilsonville, ORFood/CosmeticsNo Action Indicated (NAI)3014585
Feb 22, 2022Houston, TXFood/CosmeticsNo Action Indicated (NAI)3004345005
Nov 2, 2021Ontario, CAFood/CosmeticsNo Action Indicated (NAI)1000124971
Sep 17, 2021Denver, COFood/CosmeticsNo Action Indicated (NAI)3007427957
Mar 18, 2020Ashland, VADevicesNo Action Indicated (NAI)2000028362
Jan 21, 2020Raleigh, NCFood/CosmeticsNo Action Indicated (NAI)3004349619
Nov 14, 2019Flower Mound, TXDevicesNo Action Indicated (NAI)3010376936
Oct 25, 2019Greensburg, PADevicesNo Action Indicated (NAI)2000000458
Dec 21, 2017Nashville, TNFood/CosmeticsNo Action Indicated (NAI)3004671924
Aug 28, 2017Albuquerque, NMFood/CosmeticsNo Action Indicated (NAI)3004670091
Feb 22, 2017Saint Paul, MNFood/CosmeticsNo Action Indicated (NAI)1000116185
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

20 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 2000000369Kansas City, MO1Jul 15, 2026
FEI 1000116185Saint Paul, MN2Jan 9, 2026
FEI 3036002406Morgantown, WV1Oct 6, 2025
FEI 3004323091Granite City, IL1Apr 24, 2024
FEI 3010044066Cleveland, OH1May 23, 2023
FEI 3010057947Gainesville, FL1May 18, 2023
FEI 3004670091Albuquerque, NM2May 9, 2023
FEI 3004322793Tulsa, OK2Apr 25, 2023
FEI 3010058080Grimes, IA1Oct 31, 2022
FEI 3014585Wilsonville, OR3Mar 9, 2022
FEI 3004345005Houston, TX1Feb 22, 2022
FEI 1000124971Ontario, CA1Nov 2, 2021
FEI 3007427957Denver, CO2Sep 17, 2021
FEI 2000028362Ashland, VA1Mar 18, 2020
FEI 3004349619Raleigh, NC2Jan 21, 2020
FEI 3010376936Flower Mound, TX1Nov 14, 2019
FEI 2000000458Greensburg, PA2Oct 25, 2019
FEI 3004671924Nashville, TN2Dec 21, 2017
FEI 1000477020Tolleson, AZ1Jan 23, 2017
FEI 3003399633Tracy, CA1Nov 20, 2015

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.