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Recalls affecting Utah

Data last updated: September 11, 2026 at 1:08 PM UTC

16,633 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 39-30-260-025 Material Number: M00573100

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27857328 GTIN: 8714729776529
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 39-30-260-025 Material Number: M00573100

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27465196 27566099 27603464 27641141 27731956 27855806 27998506 28297081 GTIN: 8714729776536
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 49-30-260-035 Material Number: M00573020

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27571949 GTIN: 8714729776734
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 49-30-450-035 Material Number: M00573030

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27951184 GTIN: 8714729776741
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers/UDI: 27877022 8714729750031 28098229 8714729750031 28329450 8714729750031 27803952 8714729750079 27877021 8714729750079 27914711 8714729750079 27950226 8714729750079 28110693 8714729750079 27950225 8714729750116 28018192 8714729750116 28253295 8714729750116 28069582 8714729750154 27751896 8714729750178 27983611 8714729750178 28296770 8714729750192 27658435 8714729750239 27891175 8714729750239 28018195 8714729750239 27914712 8714729750277
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

DREAMTOME 44-30MM/260CM Material Number: M00584050

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 27708191 27709633 27787771 27789167 27899695 27924755 27971482 27976277 27979230 28047306 28054381 GTIN: 8714729778271
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

DREAMTOME 49-30MM/450CM Material Number: M00584030

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27692922 GTIN: 8714729778257
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

HYDRATOME RX 44-30MM/450CM Material Number: M00583070

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27556713 27684748 27949033 GTIN: 8714729755227
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

HYDRATOME RX 49-20MM/260CM Material Number: M00583000

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27852433 28028722 GTIN: 8714729755159
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 39-20-450-025 Material Number: M00573090

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27632862 27855805 GTIN: 8714729776550
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 44-20-450-035 Material Number: M00573050

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27535120 27643043 27730949 27836207 27571950 27591704 27625065 27773387 GTIN: 8714729776666
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27482864 GTIN: 8714729953241
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

DREAMTOME 49-20MM/450CM Material Number: M00584020

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27802363 GTIN: 8714729778240
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

DREAMTOME 49-20MM/260CM Material Number: M00584000

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27566791 27604633 27690970 27802364 27951185 28028721 GTIN: 8714729778226
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.

Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89276
Lot/product code:
Lot Numbers 210414 - 210524
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 49-20-260-035 Material Number: M00573000

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27690967 27949032 27604634 27692921 GTIN: 8714729121169
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27482863 27532553 27602969 27652583 27723139 27758892 27796835 27846707 27899139 27966498 28021411 GTIN: 8714729953258
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

CovClear COVID-19 Rapid Antigen Test, ATG 900-031

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89315
Lot/product code:
All lots
Recalling firm:
Empowered Diagnostics LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

HYDRATOME RX 44-30MM/260CM Material Number: M00583050

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27503545 27539248 27622371 27830206 27836999 27892995 27940790 GTIN: 8714729755203
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.

Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89276
Lot/product code:
UDI-DI: 00606959051942 (USA); 00606959055483 (Korea) Product Identifier (Serial Numbers): H312385987BBD H31238613E4CA H31241259862E H31241349C52A H312413624849 H31246293D7F5 H29069399D107 H29669926A6D8 H296700951ED2 H296701855DD6 H29674238FF13 H296742474AEC H31220934079E H312209523678 H31220968B34A H280964980B5B H2967018997BA H296723150600 H2967242692F6 H296742253D2E H29674250278B H312207401CA9 H312208968320 H312209071F6D H31220910720A H3122091706B5 H31220928D42A H29670062E9A5 H29670177FD0C H2967017805FB H29672401D5F9 H29672403F6EB H29674270143B H297843621AFA H312413504133 H312209241E46 H312209466984 H2967239902AC H31220819B517 H312208463358 H31220879E1C7 H3122089792A9 H3122092149EB H3122086600E8 H3122093262A8 H31220939DC7B H31220950156A H312209603F02 H31220996D9FC H3122081028D6 H3122083329FD H31220840566E H312208540992 H3122086065DE H31220844104A H312209006BD2 H31220908E79A H3122093041BA H311986468D0A H31198653C37F H31198703E71B H311987378B57 H31199129B193 H311991651C9F H312002723AE6 H3120033750F7 H3120041817B5 H31200649CD3C H3120080642B0 H312008165B68 H312010168111 H3120105192CE H312010580F0F H31201122B781 H31201136E87D H31201153EB00 H31201160F3F3 H31206064B82A H31238478BB71 H31238600CF89 H312386149075 H31238626990F H312413562405 H312413642D7F H312413653CF6 H312413671FE4 H312413707283 H31245188BA57 H31246258C086 H3124630068AA H29670055B772 H29670089CD66 H29670120F70B H29670195440E H296723243DE1 H29672330621D H2967240593DD H29672456DFFE H296742224991 H29784208BBAC H312209272CDD H312209400CB2 H31192401F7C3 H311924097B8B H311924178B2D H3119242493DE H31192433FEB9 H31192470AB42 H3119247399D9 H31192474ED66 H31216909A045 H31216910245C H3121691573F1 H31217046BF77 H312170485609 H31217092492B H31217104A1D9 H312171178A9A H31217131DC1C H31217132EE87 H312171348BB1 H312171359A38 H31217137B92A H312171395054 H31217140809D H31217142A38F H31217146E5AB H312171491D5C H312171509945 H31217152BA57 H31217154DF61 H31217156FC73 H31217158150D H312171590484 H31217161A2A4 H3121716381B6 H31217165E480 H31217167C792 H312171683F65 H312171692EEC H31217171BB7C H3121717289E7 H31217173986E H31217174ECD1 H31217175FD58 H3121717826BD H312171793734 H31220719FFD0 H312207226B6B H312207237AE2 H312207240E5D H312207262D4F H312207314028 H31220733633A H312207341785 H31220737251E H312207432E32 H312207454B04 H312207476816 H312207522663 H3122075552DC H3122075771CE H31220881EE47 H3122095761D5 H312209630D99 H312209665A34 H31220997C875 H312208354CCB H312208376FD9 H31220842757C H31220849CBAF H312208573B09 H312208671161 H31220868E996 H312208743A22 H3122087708B9 H312209035949 H3121691135D5 H31217033A5D2 H312171480CD5 H31217176CFC3 H31220738DDE9 H312208175C69 H312208299F7F H31220869F81F H31220883CD55 H31220954534E H3119904310C5 H31200467A24A H31200537862E H312006146861 H312008735815 H31200991BBCB H312012037ADC H312022674DE5 H312058755374 H31207455FC11 H31208096B6B2 H31217042F953 H312170906A39 H31217144C6B9 H31217145D730 H31217166D61B H31217177DE4A H31220804772A H31220808BD46 H3122082002BE H3120592203AF H31217103D566 H31217147F422 H312208277601 H312208310AEF H312208526CA4 H31220919EFCB H312209983082 H31226199AC53 H3122724163BC H312272425127 H31227263731E H312272727B4F H31227280DB95 H31227293F0D6 H312273127543 H3122731722EE H31227319CB90 H312273252B94 H31227329E1F8 H31227335324C H31227386E47F H31227397EC2E H312274194795 H31227534F51C H31227562EE92 H3122756841C8 H31227577A0E7 H31227587232F H312276043010 H312276124CFE H31227623771F H3122764323CF H312276511905 H312276712AB5 H31227679A6FD H31227697D593 H312277031E73 H31227708A0A0 H31227719A8F1 H3122772548F5 H3122773663B6 H312277451C25 H31227758DE18 H31227769E5F9 H31227777155F H31227784A40C H31227785B585 H31227786871E H312277879697 H312278315DCE H31227838C00F H3122784333D4 H312278499C8E H312278702B27 H31227884EECB H31227908B0BB H31227914630F H312279389AD3 H312279436908 H3122796179AA H312279671C9C H3122797437DF H31227985A59E H31228003208F H312280089E5C H312280155C61 H31228023133F H3122803129F5 H3122804522D9 H312280524FBE H312280651169 H31228069DB05 H31228086B9E2 H31228090C50C H312280948328 H312280984944 H312281026BDA H312281040EEC H31228108C480 H312313453F9A H31231358FDA7 H31231369C646 H31231374047B H312313985407 H31231403B1C9 H31231406E664 H31231412B998 H31231421A16B H31231426D5D4 H31231430A93A H31231434EF1E H31231441F5BB H31231445B39F H31231450FDEA H3123145698DC H3123146491A6 H312314694A43 H31231472ED48 H31231474887E H312314804D92 H312314837F09 H31231488C1DA H31231500D98E H31231502FA9C H31231507AD31 H312315148672 H31231517B4E9 H31248710BC51 H31248711ADD8 H312487129F43 H312487138ECA H31248714FA75 H31248715EBFC H31248716D967 H31248717C8EE H312487183019 H312487192190 H312487209639 H3124872187B0 H312487308FE1 H31248733BD7A H31248734C9C5 H31248735D84C H31248736EAD7 H31248737FB5E H3124873803A9 H312487391220 H31248740C2E9 H31248741D360 H31248742E1FB H31248743F072 H31248752F823 H31248753E9AA H312487549D15 H312487558C9C H31248756BE07 H31248757AF8E H312487585779 H3124875946F0 H31248760F159 H31248770E881 H31248771F908 H31248772… (truncated, 7188 characters total — see the official FDA record for the full value)
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

HYDRATOME RX 44-20MM/450CM Material Number: M00583060

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

HYDRATOME RX 49-30MM/260CM Material Number: M00583010

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27641142 28045346 GTIN: 8714729755166
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 44-30-450-035 Material Number: M00573070

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27737251 27970819 28289451 27821545 28019275 GTIN: 8714729776543
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

NIM TRIVANTAGE EMG Endotracheal Tube

There is potential for multiple issues due to a manufacturing nonconformity.

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89280
Lot/product code:
Products: 1) Product Number 8229705 (GTIN 00763000033934); Lots: 0218762694, 0218663943, 0219904500, 0220293429, 0220584798, 0220756285, 0220774358, 0221736070, 0221805033, 0222186741, 0222495993, 0222591367 2) Product Number 8229706 (GTIN 00763000033941); Lots: 0218663944, 0218664146, 0218762695, 0218762699, 0218762698, 0218762697, 0219010138, 0219010139, 0219010142, 0219010140, 0219010141, 0219278186, 0219272545, 0219278189, 0219278188, 0219278190, 0219444156, 0219444157, 0219278187, 0219444160, 0219444158, 0219444159, 0219444161, 0219836614, 0219972527, 0219969085, 0219972526, 0219972528, 0219836616, 0220087597, 0220087596, 0220087598, 0220293430, 0220293432, 0220293434, 0220293431, 0220293433, 0220293435, 0220371534, 0220371535, 0220371537, 0220371536, 0220517619, 0220517618, 0220584803, 0220584804, 0220734720, 0220769468, 0220769470, 0220878556, 0220769469, 0220878557, 0220934885, 0221123594, 0221123639, 0221248868, 0221248867, 0221248869, 0221493241, 0221543453, 0221543452, 0221637121, 0221637122, 0221710524, 0221805030, 0221805031, 0221805039, 0221805041, 0222048142, 0222024594, 0222057391, 0222140123, 0222200982, 0222200983, 0222200984, 0222239875, 0222239874, 0222352848, 0222396630, 0222428754, 0222465659, 0222495994, 0222495995, 0222495996, 0222542347, 0222542348, 0222563000, 0222563288, 0222738659, 0222719941, 0222684388 3) Product Number 8229707 (GTIN 00763000033958); Lots: 0218664151, 0218664148, 0218664149, 0218664157, 0218664156, 0218664155, 0218664150, 0218664154, 0218664158, 0218664153, 0218664152, 0218762700, 0218762705, 0218762701, 0218762704, 0218762703, 0218762806, 0218762702, 0218762807, 0218762812, 0218762809, 0218762814, 0218762815, 0219010143, 0219010144, 0219010145, 0219010806, 0219010807, 0219010809, 0219010813, 0219010811, 0219010810, 0219010808, 0219010812, 0219010814, 0219010816, 0219010818, 0219010819, 0219010817, 0219010820, 0219010815, 0219010821, 0219010822, 0219278191, 0219444374, 0219444375, 0219444376, 0219278193, 0219278196, 0219278195, 0219278192, 0219278197, 0219278194, 0219444369, 0219444370, 0219278198, 0219444371, 0219952959, 0219444372, 0219985176, 0219444373, 0219985177, 0219723502, 0219952958, 0220033883, 0220033885, 0220037915, 0220047459, 0220047460, 0220057008, 0220057009, 0220057010, 0220057011, 0220076607, 0220081032, 0220081037, 0220008824, 0220008823, 0220010546, 0220010547, 0220008825, 0220010548, 0220087591, 0220087602, 0220087599, 0220087601, 0220087600, 0220087603, 0220142052, 0220087886, 0220142053, 0220142054, 0220142055, 0220142060, 0220149776, 0220149778, 0220230467, 0220230468, 0220230472, 0220230469, 0220142057, 0220142058, 0220142059, 0220149779, 0220142063, 0220142064, 0220142062, 0220142065, 0220370784, 0220370785, 0220371526, 0220371528, 0220371527, 0220371530, 0220371529, 0220371531, 0220371532, 0220371533, 0220517189, 0220517190, 0220517620, 0220517621, 0220517191, 0220517193, 0220517194, 0220517192, 0220517195, 0220517196, 0220517197, 0220517199, 0220517200, 0220517198, 0220517201, 0220517202, 0220622252, 0220622253, 0220637407, 0220637408, 0220637409, 0220637410, 0220688264, 0220688265, 0220691509, 0220691510, 0220734718, 0220756281, 0220756282, 0220756283, 0220756284, 0220769471, 0220804919, 0220769472, 0220798476, 0220813969, 0220813970, 0220817687, 0220817686, 0220826216, 0220826217, 0220845825, 0220846126, 0220857889, 0220878558, 0220878559, 0220878561, 0220878560, 0220878562, 0220878563, 0220913062, 0220935486, 0220935487, 0220935488, 0220935489, 0220974382, 0221040035, 0221056071, 0221040036, 0221056072, 0221082044, 0221069155, 0221082126, 0221073627, 0221090328, 0221090327, 0221097604, 0221097605, 0221098067, 0221098066, 0221118571, 0221118572, 0221123591, 0221123638, 0221146333, 0221146457, 0221146458, 0221146460, 0221146459, 0221146461, 0221146462, 0221146463, 0221146879, 0221146889, 0221146901, 0221248875, 0221248876, 0221248877, 0221248878, 0221248879, 0221248880, 0221248881, 0221248882, 0221248883, 0221248884, 0221248885, 0221378722, 0221378724, 0221378725, 0221379386, 0221379387, 0221379388, 0221493665, 0221493866, 0221514981, 0221526915, 0221526917, 0221526918, 0221526920, 0221526919, 0221571421, 0221599118, 0221599117, 0221599181, 0221599119, 0221651974, 0221637118, 0221656119, 0221656118, 0221659143, 0221659144, 0221736003, 0221736005, 0221766209, 0221766208, 0221766211, 0221736786, 0221805043, 0221772984, 0221886337, 0221805044, 0221893434, 0221893435, 0221897719, 0221897720, 0221893433, 0221924396, 0221931540, 0221938902, 0221938901, 0221962166, 0221967955, 0222057392, 0222024589, 0222069694, 0222093329, 0222069692, 0222069693, 0222093330, 0222101075, 0222110921, 0222110922, 0222136940, 0222106107, 0222139599, 0222139600, 0222140118, 0222140119, 0222140125, 0222140446, 0222163047, 0222140120, 0222168488, 0222168489, 0222168491, 0222168492, 0222168493, 0222202227, 0222202226, 0222202228, 0222202230, 0222202231, 0222239881, 0222202232, 0222239878, 0222239882, 0222239883, 0222239884, 0222240046, 0222240047, 0222239885, … (truncated, 9812 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

FDA has not published a risk classification for this recall yet.

Recall #:
89468
Lot/product code:
Lot Numbers: 27481920 27524107 27525279 27530542 27574053 27598798 27652479 27722062 27722511 27742261 27758891 27795634 27846706 27897451 27969768 28027118 28070708 GTIN: 8714729953234
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)