BIGNOPE
Ko-fi

Recalls affecting Puerto Rico

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

16,293 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
Class IHigh risk
DrugRecalled October 12, 2021

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets

ALL 50 STATES
Full report

The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0092-2022
Lot/product code:
Lot #: 163935, Exp: 10/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 13, 2021

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

ALL 50 STATES
Full report

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

Recall #:
88930
Lot/product code:
Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 13, 2021

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.

Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

ALL 50 STATES
Full report

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

Recall #:
89104
Lot/product code:
RPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615
Recalling firm:
Cook Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

ALL 50 STATES
Full report

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

Recall #:
88840
Lot/product code:
Serial Numbers/UDI: 20514657 (01)04562122958868(11)161220(21)20514657; 20659147 (01)04562122958868(11)20181124(21)20659147; 20659148 (01)04562122958868(11)20181124(21)20659148; 20659149 (01)04562122958868(11)20181124(21)20659149; 20659150 (01)04562122958868(11)20181124(21)20659150; 20659153 (01)04562122958868(11)20181126(21)20659153; 20659154 (01)04562122958868(11)20181126(21)20659154; 20659155 (01)04562122958868(11)20181126(21)20659155; 20659156 (01)04562122958868(11)20181126(21)20659156; 205G0225 (01)04562122958868(11)20170418(21)205G0225; 205G0226 (01)04562122958868(11)20170424(21)205G0226; 205P2146 (01)04562122958868(11)20170615(21)205P2146; 205P2147 (01)04562122958868(11)20170615(21)205P2147; 205P2148 (01)04562122958868(11)20170615(21)205P2148; 205P2149 (01)04562122958868(11)20170615(21)205P2149; 205Q0809 (01)04562122958868(11)20170707(21)205Q0809; 205Q0810 (01)04562122958868(11)20170707(21)205Q0810; 205Q0812 (01)04562122958868(11)20170707(21)205Q0812; 205Q0815 (01)04562122958868(11)20171006(21)205Q0815; 205T7139 (01)04562122958868(11)20171006(21)205T7139; 205T7143 (01)04562122958868(11)20171026(21)205T7143; 205V5544 (01)04562122958868(11)20171026(21)205V5544; 205V5545 (01)04562122958868(11)20171030(21)205V5545; 205V5547 (01)04562122958868(11)20171031(21)205V5547; 205V5548 (01)04562122958868(11)20171031(21)205V5548; G3005239 (01)04562122958868(11)20190308(21)G3005239; G3005240 (01)04562122958868(11)20190308(21)G3005240; G3025041 (01)04562122958868(11)20190603(21)G3025041; G3025042 (01)04562122958868(11)20190604(21)G3025042; G3025044 (01)04562122958868(11)20190605(21)G3025044; G3025045 (01)04562122958868(11)20190605(21)G3025045; G3025048 (01)04562122958868(11)20190606(21)G3025048; G3025049 (01)04562122958868(11)20190606(21)G3025049; G3037183 (01)04562122958868(11)20190624(21)G3037183; G3037184 (01)04562122958868(11)20190624(21)G3037184; G3037192 (01)04562122958868(11)20190709(21)G3037192; G3043580 (01)04562122958868(11)20190820(21)G3043580; G3043581 (01)04562122958868(11)20190820(21)G3043581; G3043582 (01)04562122958868(11)20190820(21)G3043582; G3052217 (01)04562122958868(11)20191016(21)G3052217; G3052218 (01)04562122958868(11)20191016(21)G3052218; G3052225 (01)04562122958868(11)20191202(21)G3052225; G3052234 (01)04562122958868(11)20200128(21)G3052234; G3052236 (01)04562122958868(11)20200109(21)G3052236; G3054831 (01)04562122958868(11)20200115(21)G3054831; G3054833 (01)04562122958868(11)20191212(21)G3054833; G3054840 (01)04562122958868(11)20200115(21)G3054840; G3080616 (01)04562122958868(11)20201215(21)G3080616; G3080617 (01)04562122958868(11)20201215(21)G3080617; G3106256 (01)04562122958868(11)20210413(21)G3106256; G3106258 (01)04562122958868(11)20210413(21)G3106258; G3111572 (01)04562122958868(11)20210413(21)G3111572; G3111573 (01)04562122958868(11)20210421(21)G3111573
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual

ALL 50 STATES
Full report

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

Recall #:
88849
Lot/product code:
Serial Numbers/UDI: G3024453 (01)04562122959278(11)191029(21)G3024453 G3024456 (01)04562122959278(11)191029(21)G3024456 G3042466 (01)04562122959278(11)191115(21)G3042466 G3042471 (01)04562122959278(11)191115(21)G3042471 G3042477 (01)04562122959278(11)191115(21)G3042477 G3042478 (01)04562122959278(11)191115(21)G3042478 G3042484 (01)04562122959278(11)191115(21)G3042484 G3042486 (01)04562122959278(11)191115(21)G3042486 G3042487 (01)04562122959278(11)191115(21)G3042487 G3042496 (01)04562122959278(11)191115(21)G3042496 G3042499 (01)04562122959278(11)191115(21)G3042499 G3042501 (01)04562122959278(11)191115(21)G3042501 G3042576 (01)04562122959278(11)191220(21)G3042576 G3042578 (01)04562122959278(11)191220(21)G3042578 G3042583 (01)04562122959278(11)191220(21)G3042583 G3042584 (01)04562122959278(11)191205(21)G3042584 G3042585 (01)04562122959278(11)191205(21)G3042585 G3042587 (01)04562122959278(11)191205(21)G3042587 G3042588 (01)04562122959278(11)191220(21)G3042588 G3082956 (01)04562122959278(11)200929(21)G3082956 G3085640 (01)04562122959278(11)200929(21)G3085640 G3085644 (01)04562122959278(11)200929(21)G3085644 G3095193 (01)04562122959278(11)201211(21)G3095193 G3095194 (01)04562122959278(11)201211(21)G3095194 G3095195 (01)04562122959278(11)201211(21)G3095195 G3095197 (01)04562122959278(11)201211(21)G3095197 G3095202 (01)04562122959278(11)201211(21)G3095202 G3095445 (01)04562122959278(11)201228(21)G3095445 G3111596 (01)04562122959278(11)210401(21)G3111596 G3111597 (01)04562122959278(11)210401(21)G3111597 G3111598 (01)04562122959278(11)210401(21)G3111598 G3111605 (01)04562122959278(11)210402(21)G3111605 G3111606 (01)04562122959278(11)210402(21)G3111606 G3114264 (01)04562122959278(11)210428(21)G3114264 G3114267 (01)04562122959278(11)210428(21)G3114267 G3114366 (01)04562122959278(11)210514(21)G3114366 G3114368 (01)04562122959278(11)210514(21)G3114368 G3114372 (01)04562122959278(11)210517(21)G3114372 G3114373 (01)04562122959278(11)210517(21)G3114373 G3114376 (01)04562122959278(11)210517(21)G3114376 G3114379 (01)04562122959278(11)210517(21)G3114379 G3114399 (01)04562122959278(11)210518(21)G3114399 G3114897 (01)04562122959278(11)210519(21)G3114897 G3114902 (01)04562122959278(11)210519(21)G3114902 G3118967 (01)04562122959278(11)210528(21)G3118967 G3118968 (01)04562122959278(11)210528(21)G3118968
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

ALL 50 STATES
Full report

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

Recall #:
88840
Lot/product code:
Serial Numbers: 205W3386 (01)04562122958974(11)171114(21)205W3386; 206F7900 (01)04562122958974(11)180926(21)206F7900; 206F7901 (01)04562122958974(11)180926(21)206F7901; 206F7936 (01)04562122958974(11)181113(21)206F7936; 206F7937 (01)04562122958974(11)181113(21)206F7937; 206F7940 (01)04562122958974(11)181113(21)206F7940; 206F7941 (01)04562122958974(11)181113(21)206F7941; 206F7942 (01)04562122958974(11)181113(21)206F7942; 206F7944 (01)04562122958974(11)181113(21)206F7944; 206F7945 (01)04562122958974(11)181113(21)206F7945; 206F7946 (01)04562122958974(11)181113(21)206F7946; 206F7947 (01)04562122958974(11)181114(21)206F7947; G3002552 (01)04562122958974(11)20190115(21)G3002552; G3024545 (01)04562122958974(11)190607(21)G3024545; G3037885 (01)04562122958974(11)20190719(21)G3037885; G3037887 (01)04562122958974(11)20190719(21)G3037887; G3042405 (01)04562122958974(11)190829(21)G3042405; G3042823 (01)04562122958974(11)20190807(21)G3042823; G3042828 (01)04562122958974(11)20190808(21)G3042828; G3045094 (01)04562122958974(11)20190822(21)G3045094; G3052105 (01)04562122958974(11)20191008(21)G3052105 G3052118 (01)04562122958974(11)20191025(21)G3052118 G3055549 (01)04562122958974(11)20191118(21)G3055549 G3055550 (01)04562122958974(11)20191118(21)G3055550 G3055552 (01)04562122958974(11)20191118(21)G3055552 G3055553 (01)04562122958974(11)20191118(21)G3055553 G3055554 (01)04562122958974(11)20191118(21)G3055554 G3055555 (01)04562122958974(11)20191118(21)G3055555 G3060234 (01)04562122958974(11)20191206(21)G3060234 G3060254 (01)04562122958974(11)20191206(21)G3060254 G3060275 (01)04562122958974(11)20191216(21)G3060275 G3060278 (01)04562122958974(11)20191216(21)G3060278 G3060690 (01)04562122958974(11)200127(21)G3060690 G3071074 (01)04562122958974(11)20200227(21)G3071074 G3080785 (01)04562122958974(11)201105(21)G3080785 G3090450 (01)04562122958974(11)201225(21)G3090450 G3110884 (01)04562122958974(11)210401(21)G3110884
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

ALL 50 STATES
Full report

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

Recall #:
93651
Lot/product code:
Model 712001 - UDI-DI 00884838028586, all serial numbers; Model 712002 - UDI-DI 00884838082373, all serial numbers; Model 712004 - UDI-DI 08436046002173, all serial numbers; Model 712006 - UDI-DI 00884838091504, serial numbers: SN20410556 and SN21410184; Model 712007 - UDI-DI)08436046002357, serial numbers: 26, 27, 19410038, 19410044, 19410046, 21410261, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410339, 21410340, 21410341, 21410342, 21410345, 22410022, 22410023, SN0410157, SN1410049, SN19410034, SN19410035, SN19410036, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410129, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, SN20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410555, SN20410556, SN20410557, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410094, SN21410099, SN21410103, SN21410104, SN21410105, SN21410117, SN21410118, SN21410119, SN21410130, SN21410131, SN21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, SN21410213, SN21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, and SNZY204110015.
Recalling firm:
SEDECAL SA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

ALL 50 STATES
Full report

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

Recall #:
88840
Lot/product code:
Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G3108401; G3114959 (01)04562122959841(11)210524(21)G3114959
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETBF2313C166EE STENT GRAFT ETBF2313C166EE ENDUR II BIF ETBF2513C124EE STENT GRAFT ETBF2513C124EE ENDUR II BIF ET

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

ALL 50 STATES
Full report

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

Recall #:
88951
Lot/product code:
Model Number/GTIN Code/Product Description: ETBF2513C145EE 00643169781047 V30584649 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593589 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593590 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593591 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593592 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593593 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593594 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593595 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE 00643169780798 V30595328 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE 00643169780798 V30595331 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE 00643169780798 V30595332 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE 00643169780934 V30595382 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595383 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595386 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595389 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595390 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595391 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE 00643169780972 V30595456 STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595505 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595515 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595516 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595517 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596585 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596586 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596587 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596625 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596626 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596634 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596635 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596637 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596639 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596640 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596641 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596644 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596645 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596646 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596648 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596649 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596650 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596651 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596655 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603296 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603298 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603309 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603310 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603311 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603312 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603313 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603315 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E 00643169232570 V30608080 STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE 00643169780897 V30609554 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609556 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609557 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609558 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609559 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609560 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609561 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609564 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E 00613994991430 V30616355 STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616364 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616365 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616368 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E 00… (truncated, 33700 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

GE Centricity Universal Viewer Zero Footprint Client

There is a potential to display incomplete patient imaging study.

ALL 50 STATES
Full report

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

Recall #:
88959
Lot/product code:
Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988.
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF231

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

ALL 50 STATES
Full report

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

Recall #:
88951
Lot/product code:
Model Number/GTIN Code/Product Description: ESBF2814C103EE 00643169780446 V30609409 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609410 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609411 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609412 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609415 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609417 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609420 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609421 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609423 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616743 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616746 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616748 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E 00643169439993 V30618898 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618899 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618902 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30618963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618964 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618965 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618966 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618967 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618968 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618969 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618970 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618971 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618972 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618973 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618974 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618975 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618976 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618977 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618978 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618979 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618980 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618982 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618983 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618984 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618988 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618989 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE 00763000098858 V30619120 STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619159 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619161 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625915 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625916 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625917 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625918 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625921 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625935 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625936 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625938 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625941 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625942 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625943 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625944 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625945 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625946 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625947 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625948 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625949 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625950 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625951 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625952 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643… (truncated, 12383 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

ALL 50 STATES
Full report

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

Recall #:
88951
Lot/product code:
Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122

There is a potential for the outer white Tyvek lid to debond from the sealed package.

Full report

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

Recall #:
88964
Lot/product code:
UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS); 39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS); 39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM); 39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE); 39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE); 39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE); 39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE); 39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM); 39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES); 39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES); 39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES)

To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.

Full report

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

Recall #:
88998
Lot/product code:
All lots with Instructions for Use Prior to PI-000078-10.0 (06/21)
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028

Xxx

Full report

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

Recall #:
88964
Lot/product code:
UDI number - (01) 07613327012996(17)261913(10); lot numbers - 86953401, 86953503
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 19, 2021

Model B35200 - Percept PC BrainSense Implantable Neurostimulator

During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

ALL 50 STATES
Full report

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

Recall #:
88889
Lot/product code:
GTIN 00763000253363, Serial Numbers: NPI714835H, NPI714811H, NPI714812H, NPI714814H, NPI714816H, NPI714817H, NPI714819H, NPI714820H, NPI714750H, NPI714764H, NPI714771H, NPI714794H, NPI714682H, NPI714709H, NPI714710H, NPI714594H, NPI714598H, NPI714599H, NPI714602H, NPI714603H, NPI714606H, NPI714564H, NPI714572H, NPI714574H, NPI714587H, NPI714588H, NPI714589H, NPI714373H, NPI714379H, NPI714331H, NPI714346H, NPI714358H, NPI714378H, NPI714128H, NPI714160H, NPI714060H, NPI713947H, NPI713956H, NPI713957H, NPI714001H, NPI714017H, NPI713948H, NPI713949H, NPI713951H, NPI713952H, NPI713953H, NPI713954H, NPI713955H, NPI713829H, NPI713371H, NPI713372H, NPI713422H, NPI713242H, NPI713188H, NPI712940H, NPI712785H, NPI712637H, NPI712405H, NPI712411H, NPI712412H, NPI712341H, NPI712302H, NPI712256H, NPI711876H, NPI711841H, NPI711475H, NPI711476H, NPI710876H, NPI710765H, NPI710561H, NPI710071H, NPI709964H, NPI709680H, NPI709654H, NPI709655H, NPI709575H, NPI708692H, NPI708699H, NPI708702H, NPI708709H, NPI708675H, NPI708653H, NPI708635H, NPI708457H, NPI708415H, NPI708417H, NPI708425H, NPI708367H, NPI708376H, NPI708358H, NPI708316H, NPI708288H, NPI708289H, NPI708292H, NPI708295H, NPI708299H, NPI708300H, NPI708305H, NPI708306H, NPI708309H, NPI708258H, NPI708262H, NPI708273H, NPI708127H, NPI708128H, NPI708153H, NPI708101H, NPI708102H, NPI708103H, NPI708106H, NPI708107H, NPI708110H, NPI708112H, NPI708113H, NPI708114H, NPI708117H, NPI708118H, NPI708120H, NPI708121H, NPI708123H, NPI708124H, NPI708125H, NPI708079H, NPI708080H, NPI708082H, NPI708083H, NPI708084H, NPI708085H, NPI708086H, NPI708087H, NPI708088H, NPI708089H, NPI708090H, NPI708091H, NPI708092H, NPI708093H, NPI708094H, NPI708095H, NPI708096H, NPI708097H, NPI708100H, NPI708105H, NPI708108H, NPI708109H, NPI708116H, NPI708126H, NPI708056H, NPI708059H, NPI708060H, NPI708062H, NPI708063H, NPI708064H, NPI708065H, NPI708066H, NPI708067H, NPI708068H, NPI708070H, NPI708071H, NPI708073H, NPI708074H, NPI708076H, NPI708077H, NPI708078H, NPI708081H, NPI708014H, NPI708037H, NPI708038H, NPI708039H, NPI708040H, NPI708041H, NPI708042H, NPI708043H, NPI708044H, NPI708045H, NPI708046H, NPI708048H, NPI708049H, NPI708050H, NPI708055H, NPI708057H, NPI707998H, NPI707999H, NPI708001H, NPI708002H, NPI708003H, NPI708004H, NPI708005H, NPI708007H, NPI708008H, NPI708009H, NPI708011H, NPI708012H, NPI708013H, NPI708015H, NPI708016H, NPI708017H, NPI708018H, NPI708020H, NPI708021H, NPI708022H, NPI708023H, NPI708024H, NPI708025H, NPI708026H, NPI708027H, NPI708028H, NPI708030H, NPI708031H, NPI708033H, NPI708034H, NPI708036H, NPI707947H, NPI707955H, NPI707956H, NPI707961H, NPI707964H, NPI707970H, NPI707972H, NPI707975H, NPI707978H, NPI707979H, NPI707982H, NPI707983H, NPI707985H, NPI707986H, NPI707987H, NPI707989H, NPI707990H, NPI707991H, NPI707992H, NPI707993H, NPI707995H, NPI707996H, NPI707997H, NPI708000H, NPI707942H, NPI707943H, NPI707944H, NPI707945H, NPI707946H, NPI707948H, NPI707949H, NPI707950H, NPI707951H, NPI707952H, NPI707953H, NPI707954H, NPI707957H, NPI707958H, NPI707959H, NPI707962H, NPI707963H, NPI707966H, NPI707968H, NPI707969H, NPI707971H, NPI707974H, NPI707976H, NPI707977H, NPI707918H, NPI707919H, NPI707920H, NPI707922H, NPI707923H, NPI707924H, NPI707925H, NPI707927H, NPI707928H, NPI707929H, NPI707930H, NPI707931H, NPI707932H, NPI707934H, NPI707935H, NPI707937H, NPI707938H, NPI707939H, NPI707880H, NPI707881H, NPI707883H, NPI707884H, NPI707885H, NPI707886H, NPI707888H, NPI707890H, NPI707905H, NPI707907H, NPI707914H, NPI707916H, NPI707870H, NPI707871H, NPI707872H, NPI707873H, NPI707874H, NPI707875H, NPI707877H, NPI707879H, NPI707889H, NPI707893H, NPI707894H, NPI707895H, NPI707896H, NPI707897H, NPI707898H, NPI707899H, NPI707900H, NPI707901H, NPI707902H, NPI707846H, NPI707847H, NPI707848H, NPI707849H, NPI707856H, NPI707857H, NPI707858H, NPI707860H, NPI707861H, NPI707862H, NPI707864H, NPI707865H, NPI707867H, NPI707868H, NPI707869H, NPI707828H, NPI707830H, NPI707831H, NPI707832H, NPI707833H, NPI707834H, NPI707835H, NPI707836H, NPI707837H, NPI707838H, NPI707839H, NPI707840H, NPI707841H, NPI707842H, NPI707843H, NPI707844H, NPI707845H, NPI707851H, NPI707852H, NPI707855H, NPI707811H, NPI707812H, NPI707813H, NPI707814H, NPI707816H, NPI707818H, NPI707819H, NPI707820H, NPI707821H, NPI707822H, NPI707824H, NPI707791H, NPI707792H, NPI707794H, NPI707795H, NPI707797H, NPI707798H, NPI707799H, NPI707800H, NPI707802H, NPI707804H, NPI707805H, NPI707806H, NPI707807H, NPI707808H, NPI707809H, NPI707774H, NPI707776H, NPI707777H, NPI707779H, NPI707780H, NPI707782H, NPI707783H, NPI707784H, NPI707786H, NPI707788H, NPI707789H, NPI707790H, NPI707749H, NPI707750H, NPI707752H, NPI707753H, NPI707754H, NPI707755H, NPI707756H, NPI707757H, NPI707758H, NPI707762H, NPI707763H, NPI707764H, NPI707765H, NPI707766H, NPI707767H, NPI707768H, NPI707769H, NPI707770H, NPI707771H, NPI707772H, NPI707720H, NPI707721H, NPI707722H, NPI707723H, NPI707724H, NPI707725H, NPI707727H, NPI707728H, NPI707730H, NPI707731H, NPI707732H, NPI707733H, NPI707… (truncated, 120757 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 19, 2021

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

ALL 50 STATES
Full report

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

Recall #:
89711
Lot/product code:
(UDI): (01)00817170020086; Lot: 2009231440; Serial Numbers: 807483, 807484, 807485, 807486, 807487, 807489, 807490, 807491, 807492, 807493, 807494, 807495, 807496, 807497, 807498, 807499, 807500, 807502, 807651, 807652, 807653, 807507, 807508, 807509, 807510, 807511, 807512, 807513, 807514, 807515, 807516, 807517, 807518, 807519, 807520, 807521, 807522, 807523, 807524, 807525, 807526, 807527, 807528, 807529, 807530, 807531, 807532, 807533, 807534, 807535, 807536, 807537, 807538, 807539, 807540, 807541, 807542, 807543, 807544, 807545, 807546, 807547, 807548, 807549, 807550, 807551, 807552, 807553, 807554, 807654, 807655, 807656, 807657, 807658
Recalling firm:
InfuTronix LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
GTIN: 08714729283805 Lot Numbers: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699. Exp. 05/19/2022 to 05/13/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
GTIN: 08714729283836 Batches: 25576770, 25576881, 25576882, 25576883, 25576884, 25576885, 25608762, 25623386, 25623387, 25623388, 25623389, 25623390, 25623391, 25623392, 25623393, 25623394, 25623395, 25623396, 25623397, 25623398, 25649814, 25649817, 25649820, 25649821, 25649825, 25649826, 25649830, 25649831, 25678823, 25678827, 25678832, 25678837, 25680097, 25704217, 25704218, 25704219, 25704220, 25704221, 25704222, 25704223, 25739152, 25739153, 25739154, 25739155, 25739157, 25739158, 25771773, 25771774, 25771775, 25771776, 25771777, 25771778, 25836083, 25836084, 25836085, 25836086, 25836087, 25836088, 25836089, 25836090, 25836091, 25836092, 25878557, 25878558, 25878559, 25878980, 25878981, 25878982, 25878983, 25878984, 25878985, 25940124, 25940125, 25942723, 25947907, 25947909, 25947911, 25947913, 25947915, 25975775, 25975776, 25975777, 25975778, 25995786, 25996198, 26000471, 26000476, 26000477, 26000478, 26000479, 26000580, 26000700, 26010393, 26010394, 26010395, 26010396, 26058288, 26058291, 26058293, 26058294, 26058295, 26058296, 26058297, 26087734, 26087735, 26087736, 26087737, 26087738, 26087739, 26087740, 26087741, 26123187, 26123188, 26123189, 26123190, 26123191, 26123247, 26123248, 26123249, 26175470, 26175471, 26175472, 26175473, 26207983, 26207984, 26207985, 26207986, 26207987, 26207988, 26207989, 26207990, 26207991, 26238132, 26238133, 26238134, 26240368, 26240370, 26240371, 26240373, 26247248, 26247249, 26247250, 26247251, 26247252, 26247253, 26247254, 26247255, 26247256, 26247257, 26283632, 26283633, 26283634, 26283635, 26283636, 26283637, 26283638, 26283639, 26284140, 26284141, 26284142, 26284143, 26324749, 26324751, 26324752, 26324754, 26350404, 26350405, 26350406, 26350407, 26356444, 26366753, 26366754, 26366755, 26366756, 26366757, 26406522, 26406523, 26406524, 26406525, 26406526, 26406527, 26406528, 26406529, 26406530, 26406531, 26426921, 26426922, 26426923, 26428970, 26429811, 26429812, 26435537, 26435538, 26435539, 26435580, 26452047, 26456916, 26456917, 26462399, 26473523, 26473769, 26473770, 26473771, 26473772, 26473773, 26473774, 26495372, 26495950, 26500637, 26500638, 26512452, 26512453, 26512454, 26512455, 26512456, 26512457, 26512458, 26512459, 26512480, 26512481, 26512483, 26512485, 26549972, 26552065, 26556788, 26556789, 26559542, 26559543, 26559544, 26559548, 26581407, 26581408, 26582103, 26582104, 26582105, 26582106, 26582107, 26588072, 26588073, 26588074, 26588075, 26588076, 26628443, 26628444, 26638830, 26638831, 26651713, 26651714, 26651715, 26651716, 26665561, 26665567, 26665571, 26665572, 26665573, 26685875, 26685876, 26685877, 26685878, 26685879, 26699192, 26699193, 26699194, 26699195, 26699196, 26699197, 26728782, 26728784, 26728785, 26759345, 26760530, 26778894, 26778895, 26778896, 26778897, 26778898, 26779080, 26779081, 26779082, 26779083, 26793782, 26793783, 26793784, 26808197, 26808198, 26808199, 26808300, 26808301, 26808302, 26808303, 26848720, 26848721, 26848722, 26848723, 26848724, 26848725, 26871168, 26871169, 26871170, 26871171, 26871172, 26871173, 26871174, 26910997, 26910998, 26910999, 26911840, 26911841, 26911842, 26911845, 26919040, 26919041, 26919042, 26960166, 26960167, 26960168, 26960169, 26960170, 26960171, 26960172, 26960173, 26960174, 26960175, 27009668, 27027289, 27027290, 27027291, 27027292, 27062054, 27062055, 27062056, 27062057, 27065830, 27065831, 27065832, 27065833, 27065834, 27065835, 27100017, 27100018, 27100019, 27100240, 27100241, 27100242, 27110096, 27110097, 27121582, 27121583, 27121584, 27121585, 27121620, 27121621, 27121625, 27148636, 27148637, 27148638, 27162326, 27162327, 27162328, 27162329, 27182896, 27182897, 27182898, 27182899, 27203768, 27203769, 27203770, 27203771, 27203772, 27203773, 27255217, 27255219, 27255220, 27255221, 27255222, 27255223, 27308422, 27308423, 27308424, 27308425, 27335091, 27335092, 27335093, 27335094, 27340629, 27340630, 27340632, 27340633, 27340634, 27340638, 27347592, 27347593, 27384705, 27384706, 27384713, 27384715. Exp. 05/10/2022 to 05/26/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
Batches: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. GTIN: 08714729283843 Exp. 05/27/2022 to 05/26/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
Batches: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
GTIN: 8714729283829 Batches: 25623385, 25678822, 25739151, 25771772, 25975774, 26010392, 26051928, 26087733, 26123186, 26175469, 26406521, 26429810, 26456904, 26579839, 26581406, 26601326, 26660957, 26793786, 26896864, 27026985, 27096335, 27226570, 27255234, 27400203. Exp. 05/23/2022 to 05/28/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
Batches: 25608760, 25612672, 25649815, 25649818, 25649822, 25649823, 25649827, 25649828, 25649832, 25649833, 25678824, 25678828, 25678829, 25678833, 25678834, 25678838, 25680098, 25680099, 25704224, 25704225, 25704226, 25704227, 25704228, 25704229, 25739159, 25739160, 25739161, 25739162, 25739163, 25739164, 25739165, 25739166, 25739167, 25739168, 25788242, 25789369, 25789801, 25836093, 25836094, 25836095, 25836096, 25836097, 25836098, 25836099, 25836140, 25836141, 25836142, 25836143, 25836144, 25836145, 25878556, 25894780, 25894781, 25894782, 25916457, 25939485, 25939684, 25940126, 25940127, 25940131, 25947920, 25947921, 25975779, 25975780, 25975781, 25975782, 25975783, 25975784, 25975785, 25975786, 25975787, 26000581, 26000582, 26000583, 26000584, 26051925, 26051926, 26051927, 26058299, 26058420, 26058421, 26058422, 26058425, 26096221, 26096222, 26096223, 26099224, 26123192, 26123193, 26123194, 26123195, 26123196, 26123250, 26123251, 26175474, 26175475, 26175476, 26175477, 26175478, 26175479, 26175500, 26207992, 26207993, 26207994, 26207995, 26207996, 26207997, 26207998, 26238135, 26240374, 26240376, 26240377, 26240378, 26247258, 26247259, 26247280, 26247281, 26247282, 26247283, 26247284, 26247285, 26284144, 26284145, 26284146, 26284147, 26284148, 26284149, 26284150, 26284151, 26324756, 26324758, 26324760, 26324762, 26324764, 26324765, 26324767, 26350408, 26351999, 26356443, 26366758, 26366759, 26366760, 26366761, 26366762, 26366763, 26366764, 26366765, 26366766, 26395974, 26406533, 26406534, 26406535, 26406536, 26406537, 226435588, 26456918, 26456919, 26473775, 26473776, 26473777, 26473778, 26491312, 26491313, 26491314, 26491319, 26491480, 26512487, 26512488, 26512490, 26527375, 26527376, 26527377, 26527378, 26551465, 26551466, 26551467, 26551468, 26551470, 26577498, 26613121, 26614494, 26614495, 26614496, 26614497, 26614498, 26614800, 26614801, 26628445, 26628446, 26628447, 26651711, 26651712, 26665036, 26665037, 26665038, 26665039, 26665360, 26665361, 26696684, 26696685, 26696686, 26696687, 26706788, 26706789, 26706790, 26706791, 26706792, 26706793, 26706794, 26760454, 26760456, 26760458, 26760459, 26760520, 26760521, 26760522, 26760523, 26760524, 26760525, 26779085, 26799125, 26799126, 26799127, 26799128, 26799129, 26818882, 26818883, 26818884, 26818885, 26818886, 26818887, 26818888, 26818889, 26818890, 26818891, 26818892, 26848726, 26848727, 26848728, 26848729, 26848730, 26848731, 26888163, 26888164, 26888165, 26888166, 26888167, 26888168, 26910996, 26919048, 26919049, 26919050, 26919051, 26919341, 26990595, 26990596, 26990598, 26990599, 26990980, 26990981, 26990982, 27008813, 27008814, 27008815, 27008816, 27008817, 27009671, 27027284, 27027285, 27027286, 27027287, 27027288, 27055010, 27055018, 27062058, 27065836, 27065837, 27065838, 27065839, 27074113, 27074114, 27100243, 27100244, 27110098, 27110099, 27110720, 27121586, 27121587, 27121588, 27121589, 27148635, 27162330, 27162331, 27162332, 27183300, 27183301, 27183302, 27203774, 27203775, 27203776, 27203777, 27203778, 27203779, 27255225, 27255226, 27255227, 27255228, 27255229, 27255230, 27255231, 27255232, 27255233, 27265232, 27269957, 27269958, 27269959, 27308426, 27308427, 27335095, 27335096, 27335097, 27347594, 27347595, 27347596, 27384709, 27393786, 27407169, 27408779, 27408920, 274089216406538, 26426920, 26435582, 26435583, 26435585, 26435586, 26435587, 26435588, 26456918, 26456919, 26473775, 26473776, 26473777, 26473778, 26491312, 26491313, 26491314, 26491319, 26491480, 26512487, 26512488, 26512490, 26527375, 26527376, 26527377, 26527378, 26551465, 26551466, 26551467, 26551468, 26551470, 26577498, 26613121, 26614494, 26614495, 26614496, 26614497, 26614498, 26614800, 26614801, 26628445, 26628446, 26628447, 26651711, 26651712, 26665036, 26665037, 26665038, 26665039, 26665360, 26665361, 26696684, 26696685, 26696686, 26696687, 26706788, 26706789, 26706790, 26706791, 26706792, 26706793, 26706794, 26760454, 26760456, 26760458, 26760459, 26760520, 26760521, 26760522, 26760523, 26760524, 26760525, 26779085, 26799125, 26799126, 26799127, 26799128, 26799129, 26818882, 26818883, 26818884, 26818885, 26818886, 26818887, 26818888, 26818889, 26818890, 26818891, 26818892, 26848726, 26848727, 26848728, 26848729, 26848730, 26848731, 26888163, 26888164, 26888165, 26888166, 26888167, 26888168, 26910996, 26919048, 26919049, 26919050, 26919051, 26919341, 26990595, 26990596, 26990598, 26990599, 26990980, 26990981, 26990982, 27008813, 27008814, 27008815, 27008816, 27008817, 27009671, 27027284, 27027285, 27027286, 27027287, 27027288, 27055010, 27055018, 27062058, 27065836, 27065837, 27065838, 27065839, 27074113, 27074114, 27100243, 27100244, 27110098, 27110099, 27110720, 27121586, 27121587, 27121588, 27121589, 27148635, 27162330, 27162331, 27162332, 27183300, 27183301, 27183302, 27203774, 27203775, 27203776, 27203777, 27203778, 27203779, 27255225, 27255226, 27255227, 27255228, 27255229, 27255230, 27255231, 27255232, 27255233, 27265232, 27269957, 27269958, 27269959, 27… (truncated, 5190 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
GTIN: 08714729283812 Lot Numbers: 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612673, 25612674, 25623377, 25623378, 25623379, 25623380, 25623381, 25623382, 25623383, 25623384, 25640115, 25649813, 25649816, 25678821, 25678826, 25678831, 25678836, 25680096, 25704209, 25704210, 25704211, 25704212, 25704213, 25704214, 25704215, 25704216, 25739146, 25739147, 25739149, 25739150, 25771761, 25771762, 25771763, 25771764, 25771765, 25771766, 25771767, 25771768, 25771769, 25771770, 25771771, 25836081, 25836082, 25878553, 25878554, 25878555, 25894783, 25916270, 25916271, 25916445, 25916446, 25940122, 25940123, 25947675, 25947677, 25947678, 25947900, 25947902, 25947904, 25947905, 25975766, 25975767, 25975768, 25975769, 25975770, 25975771, 25975772, 25975773, 26000472, 26000473, 26000474, 26000475, 26000696, 26000697, 26000698, 26000699, 26010388, 26010389, 26010390, 26010391, 26058285, 26058286, 26087174, 26087175, 26087176, 26087177, 26087178, 26087179, 26087720, 26087721, 26087722, 26087723, 26087724, 26087725, 26087726, 26087727, 26087728, 26087729, 26087730, 26087731, 26087732, 26123182, 26123183, 26123184, 26123185, 26123244, 26123245, 26123246, 26175465, 26175466, 26175467, 26175468, 26207974, 26207975, 26207976, 26207977, 26207978, 26207979, 26207980, 26207981, 26207982, 26238131, 26240367, 26247246, 26247247, 26283625, 26283626, 26283627, 26283628, 26283629, 26283630, 26283631, 26324745, 26324747, 26344528, 26344529, 26348351, 26356445, 26366747, 26366748, 26366749, 26366750, 26366751, 26366752, 26406514, 26406515, 26406516, 26406517, 26406518, 26406519, 26406520, 26429809, 26435534, 26435535, 26435536, 26444430, 26447362, 26447363, 26449367, 26456914, 26456915, 26473765, 26473766, 26473767, 26473768, 26495948, 26499146, 26501878, 26511846, 26512444, 26512445, 26512446, 26512447, 26512448, 26512449, 26512450, 26512451, 26540309, 26556786, 26556787, 26559139, 26559540, 26559541, 26559546, 26559547, 26581401, 26581402, 26581403, 26581404, 26581405, 26582100, 26582101, 26582102, 26588068, 26588069, 26588070, 26588071, 26628440, 26628441, 26628442, 26638828, 26638829, 26651717, 26660956, 26665449, 26665450, 26665458, 26665560, 26677021, 26685872, 26685873, 26685874, 26699186, 26699187, 26699188, 26699189, 26699190, 26699191, 26728358, 26728359, 26728780, 26728781, 26769421, 26778891, 26778892, 26778893, 26792383, 26792384, 26792386, 26793780, 26793781, 26808194, 26808195, 26808196, 26818638, 26818639, 26818880, 26818881, 26848716, 26848717, 26848718, 26848719, 26872354, 26872355, 26872356, 26872357, 26872358, 26906626, 26906627, 26906628, 26906629, 26906630, 26906631, 26919043, 26919044, 26919045, 26919046, 26919047, 26940194, 26956470, 26956471, 26956472, 26956473, 26956474, 26956475, 26956476, 26956477, 26956478, 26956479, 27008818, 27008819, 27025671, 27027293, 27027294, 27027295, 27027296, 27027297, 27027298, 27027299, 27065828, 27065829, 27074111, 27074112, 27100015, 27100016, 27110095, 27121580, 27121581, 27121622, 27121623, 27121624, 27162322, 27162323, 27162324, 27162325, 27182893, 27182894, 27182895, 27183306, 27183307, 27183308, 27203712, 27203713, 27203714, 27203715, 27203716, 27203717, 27203718, 27203719, 27203760, 27203761, 27203762, 27203763, 27203764, 27203765, 27203766, 27203767, 27255211, 27255212, 27255213, 27255214, 27265231, 27269950, 27269951, 27269953, 27269954, 27269955, 27308420, 27308421, 27335099, 27335460, 27340626, 27340636, 27340637, 27347590, 27347591, 27384704, 27393782, 27408924 Exp. 05/10/2022 to 05/31/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
Full report

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

Recall #:
88991
Lot/product code:
Batches: 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170, 25806714, 25819946, 25819947, 25819948, 25836147, 25836148, 25850475, 25850476, 25850477, 25850478, 25850479, 25850540, 25850541, 25878986, 25878987, 25878988, 25878989, 25878990, 25878991, 25930854, 25940128, 25940129, 25940130, 25963979, 25969161, 25969162, 25975788, 25975789, 25975790, 25975791, 26010399, 26010400, 26047895, 26047896, 26047897, 26047898, 26047899, 26048760, 26058432, 26059172, 26123198, 26123199, 26123240, 26123241, 26123242, 26123243, 26123252, 26123253, 26175502, 26175503, 26175504, 26175505, 26207999, 26208000, 26208001, 26208002, 26208003, 26240379, 26247286, 26247287, 26247288, 26247289, 26284152, 26284153, 26284154, 26284155, 26284156, 26324769, 26324771, 26324773, 26324775, 26350409, 26356442, 26366767, 26366768, 26366769, 26366770, 26366771, 26366772, 26366773, 26366774, 26406539, 26406560, 26406561, 26406562, 26435589, 26435590, 26435591, 26440046, 26457040, 26457041, 26473800, 26473801, 26489988, 26491481, 26491482, 26491483, 26491484, 26499145, 26543699, 26545849, 26545850, 26545851, 26546369, 26549973, 26559545, 26581409, 26581410, 26581827, 26600543, 26600544, 26621751, 26628098, 26638074, 26651704, 26651705, 26651706, 26651709, 26674679, 26675080, 26675081, 26677000, 26677001, 26677002, 26686240, 26696688, 26696689, 26706795, 26706796, 26706797, 26718376, 26718377, 26739329, 26739331, 26739335, 26758738, 26759340, 26759342, 26760526, 26760527, 26760528, 26760529, 26779086, 26779087, 26779088, 26779089, 26779090, 26779092, 26779093, 26808304, 26808305, 26808306, 26808307, 26848733, 26848734, 26848735, 26848736, 26848737, 26888169, 26888170, 26888171, 26888172, 26919342, 26919343, 26919344, 26919345, 26940195, 26940196, 26940197, 26940198, 26990983, 26990984, 26990985, 26990986, 26990987, 26990988, 26990989, 26990990, 26990991, 27008809, 27008810, 27008811, 27008812, 27055019, 27055120, 27062059, 27065900, 27065901, 27074115, 27074116, 27121590, 27121591, 27121596, 27121598, 27121599, 27121626, 27148639, 27148780, 27148781, 27183303, 27183304, 27183305, 27183311, 27183312, 27219848, 27220333, 27233915, 27263158, 27263159, 27265233, 27265234, 27269980, 27269981, 27269982, 27308428, 27335462, 27347597, 27347598, 27384710, 27428069 GTIN: 08714729283874 Exp. 05/18/2022 to 06/03/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)