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Recalls affecting U.S. Virgin Islands

Data last updated: September 10, 2026 at 1:16 PM UTC

15,933 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 November 9, 2020

K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

Due to complaints received associated with cracked/split test tube caps.

ALL 50 STATES
Full report

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

Recall #:
86774
Lot/product code:
Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT
Recalling firm:
Helena Laboratories, Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2020

Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.

A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.

ALL 50 STATES
Full report

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

Recall #:
86872
Lot/product code:
Software version 1.3.80
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2020

CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000

Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.

ALL 50 STATES
Full report

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

Recall #:
86895
Lot/product code:
CareLinkTM Personal (MMT-7333) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424121  CareLinkTM system (MMT-7350) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424138
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2020

Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.

The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.

ALL 50 STATES
Full report

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

Recall #:
86829
Lot/product code:
Serial numbers:  SF16030134 SF16240121 SF16360313 SF16450067 SF17010227 SF17010247 SF17030358 SF17050642 SF17090981 SF17110474 SF17120491 SF17140419 SF17150846 SF17180407 SF17200722 SF17240406 SF18020067 SF18020101 SF18020103 SF18030281 SF18090439 SF18090443 SF18110356 SF18271901 SF18271902 SF18271903 SF18271904 SF18271905 SF18271907 SF18271908 SF18271909 SF18271910 SF18271911 SF18271912 SF18271913 SF18271914 SF18271915 SF18271916 SF18271917 SF18271918 SF18271919 SF18271920 SF18271921 SF18271922 SF18271923 SF18271924 SF18271938 SF18271941 SF18280055 SF18301062 SF18420402 SF18430101 SF18430150 SF18430151 SF18430154 SF18430155 SF18430156 SF18430158 SF18430159 SF18430161 SF18430163 SF18430164 SF18430169 SF18430171 SF18430172 SF18430173 SF18430174 SF18430176 SF18430177 SF18430179 SF18430181 SF18430182 SF18430183 SF18430187 SF18430188 SF18430193 SF18430194 SF18430195 SF18430196 SF18430197 SF19250492 SF19260529 SF19330724 SF19470574 SF19480478 SF19480479 SF19480480 SF19480484 SF19480485 SF19480486 SF19480487 SF19480488 SF19480489 SF19480490 SF19480491 SF19480492 SF19480493 SF19480494 SF19480495 SF19480496 SF19480497 SF19480498 SF19480499 SF19480500 SF19480621 SF19480622 SF19480623 SF19480624 SF19480625 SF19480626 SF19480627 SF19480628 SF19480629 SF19480630 SF19480631 SF19480632 SF19480633 SF19480634 SF19480635 SF19480636 SF19480637 SF19480638 SF19480639 SF19480640 SF19480641 SF19480642 SF19480643 SF19480644 SF19480645 SF19480646 SF19480647 SF19480648 SF19480649 SF19480650 SF19480651 SF19480652 SF19480653 SF19480654 SF19480655 SF19480656 SF19480658 SF19480659 SF19480660 SF19480661 SF19480662 SF19480663 SF19480664 SF19480665 SF19480666 SF19480667 SF19480668 SF19480669 SF19480670 SF19480671 SF19480672 SF19480673 SF19480674 SF19480675 SF19480677 SF19480678 SF19480679 SF19480680 SF19480681 SF19480682 SF19480683 SF19480684 SF19480685 SF19480686 SF19480687 SF19480688 SF19480689 SF19480690 SF19480692 SF19480693 SF19480694 SF19480695 SF19480696 SF19480697 SF19480698 SF19480699 SF19480700 SF19480701 SF19480702 SF19480703 SF19480706 SF19480707 SF19480708 SF19480710 SF19480711 SF19480713 SF19480714 SF19480715 SF19480716 SF19480718 SF19480719 SF19480720 SF19490002 SF19490004 SF19490005 SF19490006 SF19490009 SF19490010 SF19490011 SF19490012 SF19490013 SF19490018 SF19490019 SF19490023 SF19490026 SF19490027 SF19490029 SF19490030 SF19490031 SF19490032 SF19490034 SF19490035 SF19490036 SF19490037 SF19490038 SF19490039 SF19490040 SF19490043 SF19490045 SF19490047 SF19490048 SF19490050 SF19490052 SF19490053 SF19490054 SF19490055 SF19490057 SF19490060 SF19490061 SF19490062 SF19490063 SF19490064 SF19490066 SF19490067 SF19490068 SF19490069 SF19490070 SF19490071 SF19490072 SF19490073 SF19490074 SF19490075 SF19490076 SF19490077 SF19490078 SF19490079 SF19490080 SF19490081 SF19490082 SF19490083 SF19490084 SF19490085 SF19490086 SF19490087 SF19490088 SF19490089 SF19490090 SF19490091 SF19490092 SF19490093 SF19490094 SF19490095 SF19490096 SF19490097 SF19490098 SF19490099 SF19490100 SF19500001 SF19500002 SF19500003 SF19500004 SF19500005 SF19500006 SF19500007 SF19500008 SF19500009 SF19500010 SF19500011 SF19500012 SF19500013 SF19500014 SF19500015 SF19500016 SF19500017 SF19500018 SF19500019 SF19500020 SF19500021 SF19500022 SF19500023 SF19500024 SF19500025 SF19500026 SF19500027 SF19500028 SF19500029 SF19500030 SF19500031 SF19500032 SF19500033 SF19500034 SF19500035 SF19500036 SF19500037 SF19500038 SF19500039 SF19500040 SF19500041 SF19500042 SF19500043 SF19500044 SF19500045 SF19500046 SF19500047 SF19500048 SF19500049 SF19500050 SF19500051 SF19500052 SF19500053 SF19500054 SF19500055 SF19500056 SF19500057 SF19500058 SF19500059 SF19500060 SF19500061 SF19500062 SF19500063 SF19500064 SF19500065 SF19500066 SF19500067 SF19500068 SF19500069 SF19500070 SF19500071 SF19500072 SF19500073 SF19500074 SF19500075 SF19500076 SF19500077 SF19500078 SF19500079 SF19500080 SF19500081 SF19500082 SF19500083 SF19500084 SF19500085 SF19500086 SF19500087 SF19500088 SF19500089 SF19500090 SF19500091 SF19500092 SF19500093 SF19500094 SF19500095 SF19500096 SF19500097 SF19500098 SF19500099 SF19500100 SF19501201 SF19501202 SF19501203 SF19501204 SF19501205 SF19501206 SF19501207 SF19501208 SF19501209 SF19501210 SF19501211 SF19501212 SF19501213 SF19501214 SF19501215 SF19501216 SF19501217 SF19501218 SF19501219 SF19501220 SF19501221 SF19501222 SF19501223 SF19501224 SF19501225 SF19501226 SF19501227 SF19501228 SF19501229 SF19501230 SF19501231 SF19501232 SF19501233 SF19501234 SF19501235 SF19501236 SF19501237 SF19501238 SF19501239 SF19501240 SF19501241 SF19501243 SF19501244 SF19501245 SF19501246 SF19501247 SF19501248 SF19501249 SF19501250 SF19501251 SF19501252 SF19501253 SF19501254 SF19501255 SF19501256 SF19501257 SF19501258 SF19501259 SF19501261 SF19501262 SF19501263 SF19501264 SF19501265 SF19501266 SF19501267 SF19501268 SF19501269 SF19501270 SF19501271 SF19501272 SF19501274 SF19501275 SF19501276 SF19501277 SF19501278 SF19501279 SF19501280 SF19501282 SF19501284 SF19501285 SF19501287 SF19501288 … (truncated, 44588 characters total — see the official FDA record for the full value)
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2020

Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

ALL 50 STATES
Full report

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

Recall #:
86880
Lot/product code:
GTIN 08714729423768: Lots 25928323, 25928324.   GTIN 08714729423829: Lots  25928325, 25928326, 25933063, 25933064, 25933065.   GTIN 08714729772743: Lot 25965814.   GTIN 08714729765837: Lot 25966020.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2020

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

ALL 50 STATES
Full report

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

Recall #:
86880
Lot/product code:
GTIN 08714729058410:  Lots  25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349.   GTIN 08714729067986:  Lots  25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104.   GTIN 08714729068020:  Lots  25578740, 25583824.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled November 17, 2020

PHARMORIGINS CORE with Natural Orange Flavor NATURAL ENERGY and IMMUNE HEALTH Dietary Supplement 30 Servings (45g) Supplement Facts***Hordenine HCL*** Manufactured by: Fusion Health Vitality, LLC 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004 888.964.5327 UPC 7 28028 21054 5

The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
F-0180-2021
Lot/product code:
Lot # s: 200313, 200321, 200326, 200402, 200406, 200410, 200414, 200416, 200424, 200501, 200525, 200527, 200604 & 200610.
Recalling firm:
Fusion Health and Vitality LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 17, 2020

Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden

Cross contamination: the excipient was found to be contaminated with theophylline.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0149-2021
Lot/product code:
Batch # 18472036, 18472041.
Recalling firm:
BASF Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" 1.5 CX 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3533  UDIs: 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 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7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587… (truncated, 12377 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 November 18, 2020

IceSeed" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR4518  UDIs: 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075  Batch Numbers: U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSphere" 1.5 CX 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3573  UDIs: 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133  Batch Numbers: U1458, U1457, U1459, U1460, U1461, U1429, U1428, U1426, U1427, U1425, U1430, U1333, U1331, U1232, U1230, U1334, U1332, U1335, U1330, U1229, U1231, U1222, U1221, U1219, U1220, U1184, U1182, U1180, U1179, U1183, U1181, U1162, U1161, U1160, U0982, U0981, U0977, U0980, U0922, U0923, U0920, U0921, U0872, U0870, U0871, U0873, U0519, U0518, U0508, U0303, U0300, U0301, U0302, U0472, U0299, U0298, U0262, U0260, U0259, U0257, U0258, U0261, U0239, U0240, U0219, X0230, U0220, U0207, U0193, U0184, U0168, U0169, U0167, U0125, U0124, U0126, U0127, U0128, U0099, U0098, U0058, U0059, U0057, U0052, U0051, U0018, U0017, T0802, T0828, T0829, T0803, T0820, T0798, T0800, T0799, T0780, T0704, T0694, T0695, T0703, T0682, T0683, T0671, T0670, T0655, T0656, T0658, T0657, T0653, T0654, T0593, T0594, T0583, T0584, T0577, T0578, T0567, T0458, T0455, T0456, T0379, T0378, T0366, T0367, T0350, T0349, T0326, T0327, T0308, T0307, T0301, T0302, T0205, T0204, T0102, T0101, T0093, T0094, T0080, T0081, T0072, T0073, A7127, A7126, A7117, A7118, A7104, A7103, A7079, A7078, A6998, A6999, X6978, A6965, A6964, A6949, A6948, A6932, A6933, A6870, A6871, A6860, A6861, A6854, A6855, A6786, A6785, A6767, A6768, A6756, A6755, A6745, A6746, A6691, A6690, A6680, A6679, A6670, A6669, A6642, A6643, A6632, A6633, A1977, A1976, A1973, A1974, A1966, A1967, A1780, A1779, A1762, A1763, A1465, A1466, A1443, A1442, A1428, A1427, A1395, A1396, A1275, A1274, A1181, A1182
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" i-Thaw" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR4070  UDIs: 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105  Batch Numbers: U1363, U0865, U0555, U0542, U0151, U0150, U0054, U0053, U0046, U0037, U0036, T0633, T0515, T0430, T0274, T0273, T0201, T0188, T0167, A7174, A7100, A7044, A7022, A7021, A6788, A6740, A2117, A2019, A1968, A1753, A1605, A1535, A1430, A1429, A1235, U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225, G5063, G5871, G5900, G5902, G5975, P1901
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

Five IceRod" i-Thaw" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3571  UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976  Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

Five IceSphere" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3570  UDIs: 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969  Batch Numbers: U1402, U1223, U1224, U1225, U1177, U1178, U1118, U1115, U1070, U1069, U0824, U0825, U0823, U0826, U0470, U0411, U0402, U0407, U0384, U0389, U0216, U0183, U0122, U0154, U0155, T0673, T0672, T0635, T0484, T0483, T0461, T0462, T0373, T0374, T0363, T0362, T0127, T0104, T0103, A7009, A6953, A6952, A6890, A6789, A6737, A2101, A2088, A1629, A1626, A1607, A1577, A1382, A1184
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3070  UDIs: 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082  Batch Numbers: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" i-Thaw" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3572  UDIs: 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983  Batch Numbers: U1423, U1422, U1329, U1227, U1091, U1128, U1127, U1090, U0976, U1011, U0919, U0917, U0868, U0869, U0738, U0739, U0403, U0404, U0297, U0296, U0256, U0255, U0217, U0218, U0034, U0176, U0033, U0032, U0016, U0040, U0015, T0759, T0758, T0731, T0651, T0634, T0524, T0507, T0502, T0470, T0429, T0401, T0391, T0372, T0351, T0319, T0306, T0281, T0271, T0247, T0198, T0189, T0161, T0084, T0074, T0008, A7231, A7212, A7206, A7188, A7040, A7018, A6983, A6898, A6886, A6878, A6867, A6864, A6843, A6824, A6787, A6718, A6687, A6671, A6663, A6646, A2138, A2124, A2100, A2099, A2082, A2053, A2013, A2001, A1994, A1975, A1945, A1892, A1761, A1748, A1688, A1685, A1612, A1596, A1519, A1502, A1497, A1479, A1447, A1424, A1405, A1378, A1377, A1356, A1347, A1340, A1320, A1227, A1218, A1202, A1187
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3608  UDIs: 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065  Batch Numbers: U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IcePearl" 2.1 CX Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3606  UDIs: 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041  Batch Numbers: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceFORCE" 2.1 CX Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3605  UDIs: 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034  Batch Numbers: U1030, U0904, U0864, U0856, U0763, U0649, T0153, A7062, A7061, A6930, A6758, A1781, A1776, A1565, A1550, A1435, A1291
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSeed" 1.5 MRI Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3192  UDIs: 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266  Batch Numbers: U1438, U1439, U0962, U0961, U0437, U0378, T0697, T0688, T0388, T0387, A7150, A7149, A2018, A2017, A1711, A1710, A1689, A1403, A1404, A0896, A0897
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSeed" 1.5 MRI 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3194  UDIs: 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280  Batch Numbers: U1368, U1367, U1040, U0396, U0380, U0375, U0374, U0242, U0241, T0532, T0533, T0531, T0530, T0444, T0443, T0442, T0353, T0354, T0262, T0263, A6720, A6719, A6698, A6697, A2049, A2050, A1999, A1998, A1990, A1991, A1891, A1890, A1844, A1845, A1690, A1562, A1563, A1533, A1326, A1325, A1197, A1196, A1041, A1040, A1008, A1007, A0955, A0954
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" 1.5 MRI Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3193  UDIs: 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273  Batch Numbers: U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, A1150
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceEDGE" 2.4 90p Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3506  UDIs: 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594  Batch Numbers: U0288, U0287, U0062, U0060, T0433, T0434, T0416, T0417, X6836, A6781, A6782, A6762, A6761, A2078, A2079, A1529, A1373, A1374
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSeed" 1.5 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3201  UDIs: 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181  Batch Numbers: U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, A0574
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSeed" 1.5 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3202  UDIs: 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235  Batch Numbers: U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, A0284
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)