Particulate Matter recalls

1,046 recalls have been issued for particulate matter, from 2012 to 14 Oct 2026. 171 of them came in the last 12 months. 269 were classified Class I.

Total recalls1,046since 2012

Last 12 months171reported

Class I26926% of total

Ongoing287latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

1Nov '24 3 1 1Feb 1 1 14May 1 1 3Aug 7 6 16Nov 2 9 34Feb 3 2 23May 26 7 32Aug 13 4

Severity split

Class I 269 26%Class II 743 71%Class III 31 3%Other/pending 3

Why particulate matter is recalled

Particulate Matter1,046100%

Companies

Product types

Brands

By year

202615315%
2025545%
2024444%
2023515%
2022262%
2021252%
2020828%
2019919%
2018404%
2017434%

Ongoing particulate matter recalls

287 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
14 Oct 2026Drug	CLASS II	Imaavy (nipocalimab-aahu) Injection, 300 mg recalledImaavy	J&J Innovative Medicine	Particulate Matter	OH
14 Oct 2026Drug	ANNOUNCED	Par Health and Endo USA Argatroban Injection 250 mg/ (100 mg/mL) recalledPar Health and Endo USA	Par Health USA	Particulate Matter	Nationwide
9 Oct 2026Drug	ANNOUNCED	Par Pharmaceutical Brevital Sodium 500 mg/vial for Injection recalledPar Pharmaceutical	Par Health	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide

All particulate matter recalls, newest first

1,046 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
14 Oct 2026Drug	CLASS II	Imaavy (nipocalimab-aahu) Injection, 300 mg recalledImaavy	J&J Innovative Medicine	Particulate Matter	OH
14 Oct 2026Drug	ANNOUNCED	Par Health and Endo USA Argatroban Injection 250 mg/ (100 mg/mL) recalledPar Health and Endo USA	Par Health USA	Particulate Matter	Nationwide
9 Oct 2026Drug	ANNOUNCED	Par Pharmaceutical Brevital Sodium 500 mg/vial for Injection recalledPar Pharmaceutical	Par Health	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
21 Sep 2026Drug	ANNOUNCED	Par Pharmaceutical Dexmedetomidine HCl recalled by Par HealthPar Pharmaceutical	Par Health	Particulate Matter	Nationwide
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
16 Sep 2026Drug	CLASS I	Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine	American Regent	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
2 Sep 2026Drug	CLASS I	Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne	Fresenius Kabi USA	Particulate Matter	Nationwide
2 Sep 2026Drug	CLASS II	Acthar Gel (repository corticotropin injection) multiple-dose vial recalled	Mallinckrodt Hospital Products	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Tralement (trace elements injection 4*, USP) recalled by American RegentTralement	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	niCARdipine Hydrochloride Injection, USP, 25 mg/ (2.5 mg/mL) recalledNicardipine Hydrochloride	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Nitroglycerin injection, USP, 50 mg/ (5 mg/mL) recalledNitroglycerin	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Atropine Sulfate injection, USP, 1 mg/mL recalled by American RegentAtropine Sulfate	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS I	Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Acetylcysteine Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Multrys (Trace Elements Injection 4, USP), For intravenous infusion recalledMultrys	American Regent	Particulate Matter	Nationwide
26 Aug 2026Drug	CLASS II	Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalledCyanocobalamin	American Regent	Particulate Matter	Nationwide
19 Aug 2026Drug	CLASS I	Cefazolin in Dextrose, Injection recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.