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Recalls affecting Montana

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

16,414 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

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

Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060

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: 27463326 27468730 27553568 27590928 27629941 27684747 27764231 27794744 27837500 27931763 27986550 28058938 GTIN: 8714729778288
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/450CM Material Number: M00584070

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: 27625066 27805561 GTIN: 8714729778295
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

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 49-30MM/260CM Material Number: M00584010

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: 27566790 27641143 27852432 GTIN: 8714729778233
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 39-30-450-025 Material Number: M00573110

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

HYDRATOME RX 44-20MM/260CM Material Number: M00583040

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: 27439836 27440919 27493069 27496980 27499896 27750785 27753215 27825981 27879216 27880741 27931764 27934862 28032489 28043447 GTIN: 8714729755197
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 44-20MM/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

JAGTOME RX 44-30-260-035 Material Number: M00573060

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 27522394 27566792 27589267 27618168 27726335 27758466 27795807 27822419 27458135 27472063 27553565 27649356 27706277 27758465 27773622 27821544 27865086 27986549 28017367 28289453 GTIN: 8714729776673
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 Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481

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: M00575241 RX CHOLANGIOGRAM KIT: Lot Numbers"27879206, 28103331, 28336117 UDI: 8714729818380; M00575281 RX CHOLANGIOGRAM KIT Lot Numbers: 27803953, 27878151, 27919775 UDI: 8714729818410 M00575321 RX CHOLANGIOGRAM KIT Lot Numbers: 27955111, 28024443, 28269925 UDI: 8714729818427; M00575361 RX CHOLANGIOGRAM KIT Lot Number:28074763 UDI:8714729818458; M00575381 RX CHOLANGIOGRAM KIT Lot Numbers: 27755939, 27990502 UDI: 8714729818465; M00575401 RX CHOLANGIOGRAM KIT Lot NUmber: 28311945 UDI:8714729818472; M00575441 RX CHOLANGIOGRAM KIT Lot Numbers: 27673853, 27891176 , 28024444 UDI: 8714729818489; M00575481 RX CHOLANGIOGRAM KIT Lot Numbers: 27919776, 28060354 UDI: 8714729818496.
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 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)
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

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

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

ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

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

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

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 39-20-260-025 Material Number: M00573080

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: 27505913 27563424 27629942 27731957 27755861 27839657 27846391 27986551 27991931 28036372 GTIN: 8714729776642
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

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

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

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

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)