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Recalls affecting South Dakota

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

16,341 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 May 28, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

ALL 50 STATES
Full report

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

Recall #:
88250
Lot/product code:
Lot Numbers: 1730500118 1813600098 1911900076 2002900137 1733300158 1819000139 1915800109 2009300076 1801700131 1822600144 1921700146 2023300126 1804000123 1830300170 1926100253 2027200177 1804500142 1831600080 1933700125 2028200196 1809400131 1910200092 1935100121
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 28, 2021

Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

ALL 50 STATES
Full report

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

Recall #:
88250
Lot/product code:
Lot Numbers: 1733700175 1806600076 1828200123 1930200088 1800300146 1814300196 1828900141 2012100137 1805200088 1822000084 1829500128 2027200247
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 28, 2021

HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

The pump has an impeller with a shroud height that did not meet the lower control limit.

ALL 50 STATES
Full report

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

Recall #:
88135
Lot/product code:
UDI: 00888707007139. Serial Number HW42843
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 28, 2021

Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

ALL 50 STATES
Full report

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

Recall #:
88250
Lot/product code:
Lot Numbers: 1834500202 1920500219 2014900143 2020400107 1914800210 2009300121 2017500133 2023300110
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 28, 2021

Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

ALL 50 STATES
Full report

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

Recall #:
88250
Lot/product code:
Lot Numbers: 1705400292
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 28, 2021

Stimulen Collagen Moisturizing Lotion, ST9555B

Dose audit failure after sterilization process

ALL 50 STATES
Full report

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

Recall #:
88163
Lot/product code:
Lot 2104007, EXP: 02/2024
Recalling firm:
Southwest Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 28, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

ALL 50 STATES
Full report

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

Recall #:
88250
Lot/product code:
Lot Numbers: 1726300131 1805900130 1911900083 2019900069 1731900198 1813600105 1926100249 2023300142 1800300137 1827600140 1926100293 2023300118 1802400067 1835100109 2002100137 2034400093
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 28, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

ALL 50 STATES
Full report

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

Recall #:
88250
Lot/product code:
Lot Numbers: 1729700119 1817700205 1910600266 2014900148 1810400147 1828900137 2014900151 2034400131
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 28, 2021

Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P

This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).

ALL 50 STATES
Full report

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

Recall #:
88250
Lot/product code:
Lot Numbers: 1725600117 1807300169 1904900113 2009300115 1729100070 1810400154 1909400116 2019500282 1731200151 1812900134 1920500220 2021000088 1732600132 1814300200 1926100254 2027200198 1734700110 1817100089 1930900078 2028200205 1800300131 1821300123 1930900075 2034400101 1805900127 1824700118 1930900076
Recalling firm:
Covidien, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 1, 2021

Medtronic Reveal LINQ LNQ11 / PA96000

Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.

ALL 50 STATES
Full report

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

Recall #:
88175
Lot/product code:
All serial numbers distributed on or after February 23, 2017    GTIN: 643169845763, 643169845770, 643169845787, 643169845794, 643169845800, 643169845817, 643169845824, 00643169845831, 00643169845848, 00643169845855, 00643169845862, 00643169845879, 00643169845893, 00763000188382, 00763000188399, 00763000188405, 00763000188412, 00763000188429, 00763000188436, 00763000188443, 00763000188450, 00763000188467, 643169845688, 643169845695, 643169845701, 643169845718, 643169845732, 643169845749, 643169845756
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 2, 2021

Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000

Excess nylon flash on the clip.

Full report

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

Recall #:
88160
Lot/product code:
a) PART NUMBER: 3387S-40 - DBS Lead with StimLoc LOTS # : VA21YUS, VA24RVV, VA25SDK, VA26Q2S, VA27X8H, VA2980G, VA29Z9A, VA2DA2Z, VA21ZJU, VA24S65, VA25WK1, VA26XP2, VA27ZRF, VA29814, VA2A5MJ, VA2DA5Y, VA21ZYP, VA24S66, VA2613V, VA26ZFU, VA281L5, VA2985H, VA2AK84, VA2DA9E, VA222L5, VA24SRF, VA261EL, VA275SC, VA2820Y, VA29BSM, VA2APV8, VA2DEKH, VA227E2, VA24UVS, VA263GC, VA275SD, VA282CS, VA29E09, VA2B3PB, VA2DVM9, VA22LDZ, VA24ZFG, VA26460, VA276GS, VA283SF, VA29LP7, VA2B3PN, VA2DVME, VA236DC, VA254MA, VA2696J, VA277EB, VA28C1Z, VA29LPC, VA2B3PQ, VA2DVNX, VA23BWB, VA254MC, VA2696L, VA27JJV, VA28C36, VA29PPY, VA2BFSP, VA23BXM, VA254MD, VA269LV, VA27MQ3, VA28DVB, VA29S0E, VA2BHV6, VA23J1U, VA2562G, VA26AGU, VA27RMG, VA28LVR, VA29S0F, VA2CEVY, VA23J4X, VA257LH, VA26E5P, VA27SW9, VA28NFL, VA29SB3, VA2CPP0, VA23L21, VA25QDQ, VA26E5R, VA27V4Y, VA28NG1, VA29UNG, VA2CXDR, VA23S64, VA25RHC, VA26K1N, VA27WDK, VA28SC8, VA29UPA, VA2D9X8, VA24R3X, VA25S3A, VA26K1R, VA27WDP, VA28XL0, VA29Z98, VA2DA0S, VA23LXN, VA23WY0, VA2446L, VA24AFN, VA24FA2, VA25DKB, VA23WXZ, VA23X94, VA249A6, VA24EYN, VA2562K, VA23LXN, VA23WY0, VA2446L, VA24AFN, VA24FA2, VA25DKB, VA23WXZ, VA23X94, VA249A6, VA24EYN and VA2562K b) PART NUMBER: 3389S-28 DBS Lead with StimLoc LOTS #: VA25K4W, VA25CMZ and VA25DKD c) PART NUMBER: 3389S-40 - DBS Lead with StimLoc LOTS #: VA21X0Y, VA24WXJ, VA260NN, VA27QE4, VA28NFM, VA29ZU0, VA2BE8A, VA2CQET, VA21ZJV, VA25101, VA26233, VA27RET, VA28SCE, VA2A3HK, VA2BEXC, VA2CQFM, VA21ZL1, VA259WX, VA2670U, VA27REU, VA28URD, VA2A6K7, VA2BF1G, VA2CQH2, VA227NQ, VA25B79, VA2672S, VA27SWB, VA28URE, VA2ACW4, VA2BFG0, VA2CRKW, VA228PU, VA25HSZ, VA26GGZ, VA27V8S, VA28XHX, VA2ACW5, VA2BHHW, VA2D6WD, VA22C6L, VA25N4Y, VA26GPA, VA27WDE, VA28ZQ0, VA2AD57, VA2BJEH, VA2D71G, VA22KF4, VA25N50, VA26KJ3, VA27ZA2, VA28ZQ2, VA2AD5G, VA2C8BG, VA2D730, VA22MXM, VA25N6D, VA26NWG, VA27ZRE, VA291YL, VA2AH9C, VA2CABX, VA2D739, VA22TDL, VA25RSZ, VA26Q16, VA280V2, VA291YM, VA2AHHR , VA2CBQ0, VA2D73E, VA22V9R, VA25TBA, VA26Q6E, VA283SH, VA2924E, VA2AHNG, VA2CFBH, VA2DAZA, VA22VZB, VA25UBK, VA26R4H, VA2865T, VA2924F, VA2AHNM, VA2CJ4Z , VA2DAZT, VA22Y79, VA25UG1, VA26TK5, VA2893X, VA29LPD, VA2AHT7, VA2CK66, VA2DB2C, VA237AP, VA25VKR, VA26XGF, VA289WG, VA29LUC, VA2AR36, VA2CK8L, VA2DB2L, VA2382J, VA25VQD, VA26ZFV, VA289WH, VA29MUW, VA2B3SB, VA2CLRF, VA2DB2V, VA2382Y, VA25XC7, VA272ZP, VA28DN6, VA29PLU, VA2B3SC, VA2CN0F, VA2DBAU, VA2384E, VA25YHU, VA275D6, VA28E06, VA29PM8, VA2B7G5, VA2CN0H, VA2DUR8, VA239JK, VA25YHW, VA276MJ, VA28KWJ, VA29UB3, VA2BDS1, VA2CN7Z, VA2DUR9, VA23P6D, VA25YR5, VA27E9P, VA28LHR, VA29UPD, VA2BDSE, VA2CN86, VA2DURH, VA23S5Z, VA25ZJ3, VA27JJS, VA28LHU, VA29UPH, VA2BDSX, VA2CN8A, VA24PD4, VA25ZJ6, VA27K8D, VA28M21, VA29ZES, VA2BE44, VA2CNX0, VA24RVR, VA25ZUB, VA27NE2, VA28M22, VA29ZM2, VA2BE7W, VA2CNXG, VA24WXH, VA25ZWB, VA27PDB, VA28M9B, VA29ZSC, VA2BE86, VA2CPPV, VA23MM7, VA23TVY, VA240PB, VA24237, VA2493U, VA24EYM, VA24L0S VA25LHE, VA23S65, VA23WXW, VA240YK, VA2440E, VA2493V, VA24G61 VA24M5P, VA25PZU, VA23TFY, VA23X95, VA241H1, VA244QV, VA24A58, VA24G7S, VA25B78, VA25QSW, VA23TVT, VA23XYL, VA241NE, VA245W8, VA24AYZ, VA24GWZ and VA25CF3 d) PART NUMBER: 3391S-40 - DBS Lead with StimLoc LOTS #: VA2391V, VA25B91, VA2AD6N, VA2BJWK, VA2DN50 and VA2DR23 e) PART NUMBER: 3550S-01 - Spare Parts Kit for StimLoc¿ Burr Hole Cover LOTS #: 082300620, 082307020, 082307620, 082329819, 082332919, 082335119, 082335320, 82316820 and 82326919 f) PART NUMBER: 924256 - StimLoc Burr Hole Cover LOTS #: 082202020A, 082203820A, 082211120A, 082228819A, 082234520A, 082202121A, 082207920A, 082214120A, 082232319A, 082235019A and 082224219A g) PART NUMBER: DB-5000 -StimLoc Support Clips LOTS #: 082104420
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

ALL 50 STATES
Full report

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

Recall #:
88087
Lot/product code:
a) S701, Serial Numbers: 100005, 100011, 100012, 100015, 100017, 100021, 100022, 100028, 100032, 100034, 100037, 100053, 100055, 100059, 100060, 100068, 100075, 100079, 100082, 100083, 100090, 100095, 100098, 100103, 100106, 100116, 100119, 100122, 100124, 100128, 100132, 100135, 100139, 100141, 100148, 100149, 100205, 100208, 100211, 100213, 100221, 100230, 100231, 100232, 100234, 100236, 100238, 100239, 100245, 100247, 100251, 100252, 100254, 100255, 100262, 100265, 100269, 100303, 100305, 100306, 100311, 100348, 100366, 100377, 100378, 100380, 100383, 100390, 100391, 100392, 100393, 100394, 100395, 100396, 100399, 100400, 100401, 100403, 100405, 100406, 700002, 700003, 700004, 700005, 700006, 700008, 700010, 700021, 700022, 700023, 700024, 700025, 700026, 700027, 700028, 700029, 700031, 700036, 700037, 700039, 700040, 700042, 700043, 700044, 700046, 700047, 700048, 700049, 700050, 700051, 700055, 700062, 700067, 700081, 700083, 700084, 700086, 700089, 700091, 700092, 700093, 700095, 700096, 700097, 700100, 700102, 700103, 700104, 700105, 700106, 700107, 700109, 700111, 700112, 700117, 700118, 700120, 700123, 700124, 700125, 700127, 700128, 700129, 700130, 700133, 700136, 700137, 700138, 700139, 700141, 700144, 700145, 700147, 700148, 700149, 700150, 700151, 700152, 700153, 700155, 700156, 700160, 700162, 700163, 700164, 700167, 700169, 700170, 700171, 700173, 700176, 700177, 700181, 700182, 700184, 700187, 700188, 700189, 700306, 700309, 700310, 700311, 700312, 700313, 700316, 700317, 700318, 700329, 700334, 700335, 700336, 700337, 700338, 700339, 700340, 700344, 700345, 700346, 700353, 700355, 700356, 700357, 700359, 700360, 700362, 700363, 700364, 700366, 700368, 700369, 700371, 700373, 700388, 700389, 700390, 700392, 700393, 700394, 700396, 700397, 700399, 700403, 700404, 700643, 700709, 700710, 700712, 700721, 700725, 700735, 700736, 700737, 700738, 700740, 700741, 700742, 700744, 700745, 700747, 700748, 700770, 700772, 700776, 700777, 700785, 700786, 700788, 700791, 700793, 700795, 700796, 700797, 700799, 700801, 700802, 700804, 700805, 700818, 700823, 700835, 700836, 700848, 700849, 700855, 700856, 700860, 700861, 700864, 700865, 700867, 700871, 700873, 700874, 700879, 700881, 700887, 700898, 700912, 700917, 700931, 700932, 700935, 700937, 700938, 700939, 700950, 700951, 700952, 700955, 700958, 700960, 700961, 700962, 700970, 700976, 700979, 700989, 701007, 701008, 701012, 701021, 701026, 701029, 701032, 701033, 701038, 701042, 701051, 701053, 701055, 701059, 701061, 701062, 701063, 701071, 701073, 701074, 701077, 701078, 701080, 701081, 701082, 701091, 701097, 701098, 701099, 701100, 701106, 701132, 701136, 701137, 701138, 701139, 701141, 701144, 701146, 701151, 701156, 701157, 701161, 701167, 701172, 701178, 702097, 702104, 702131, 702138, 702165, 702167, 702220, 702223, 702298, 702299, 702300, 702301, 702304, 702318, 702320, 702321, 702322, 702323, 702325, 702327, 704574, 704583, 704590, 704593, 704594, 704598, 704599, 704600, 704631, 704637, 704639, 704642, 100002, 100003, 100004, 100007, 100008, 100009, 100010, 100013, 100014, 100016, 100018, 100019, 100020, 100023, 100025, 100026, 100027, 100030, 100031, 100033, 100035, 100036, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100054, 100056, 100057, 100058, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100069, 100070, 100071, 100072, 100073, 100076, 100077, 100078, 100081, 100084, 100085, 100086, 100087, 100088, 100091, 100092, 100093, 100094, 100096, 100097, 100099, 100100, 100101, 100102, 100104, 100109, 100111, 100112, 100114, 100115, 100117, 100118, 100120, 100121, 100123, 100126, 100127, 100129, 100130, 100131, 100133, 100136, 100137, 100138, 100140, 100142, 100143, 100144, 100145, 100146, 100147, 100150, 100151, 100152, 100153, 100154, 100155, 100156, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100171, 100172, 100173, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100182, 100183, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100195, 100196, 100197, 100198, 100200, 100201, 100202, 100203, 100206, 100210, 100212, 100214, 100215, 100216, 100218, 100219, 100220, 100222, 100224, 100225, 100228, 100229, 100235, 100237, 100240, 100241, 100242, 100243, 100244, 100246, 100248, 100249, 100250, 100257, 100259, 100260, 100263, 100266, 100267, 100268, 100270, 100271, 100272, 100275, 100278, 100279, 100280, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100292, 100294, 100295, 100296, 100298, 100300, 100301, 100302, 100307, 100308, 100310, 100312, 100314, 100315, 100316, 100317, 100318, 100321, 100342, 100349, 100353, 100354, 100355, 100356, 100357, 100358, 100359, 100360, 100361, 100362, 100364, 100365, 100367, 100368, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100379, 100381, 100382, 100384, 100385, 100386, 100387… (truncated, 23692 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 June 3, 2021

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

ALL 50 STATES
Full report

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

Recall #:
88087
Lot/product code:
a) L300, Serial Numbers: 712118, 713277, 713352, 713357, 713365, 713381, 713390, 713398, 713403, 713405, 713406, 713420, 713440, 713443, 713447, 713454, 713456, 713459, 713461, 713464, 713469, 713470, 713474, 713480, 713483, 713500, 713501, 713506, 713508, 713513, 713515, 713516, 713519, 713528, 713530, 713538, 713542, 713543, 713544, 713548, 713592, 713593, 713614, 713621, 713624, 713625, 713630, 713631, 713633, 713637, 713642, 713646, 713649, 713650, 713651, 713652, 713666, 713669, 713675, 713682, 713695, 713701, 713711, 713719, 713728, 713732, 713738, 713744, 713755, 713766, 713796, 713799, 713842, 714095, 714101, 714274, 714280, 719937, 719963, 719998, 720049, 720218, 720222, 720253, 720280, 707669, 713278, 713312, 713318, 713319, 713320, 713326, 713333, 713335, 713363, 713368, 713372, 713385, 713386, 713388, 713389, 713393, 713399, 713401, 713404, 713407, 713408, 713409, 713411, 713414, 713419, 713426, 713431, 713445, 713446, 713449, 713450, 713453, 713457, 713458, 713460, 713462, 713463, 713468, 713471, 713473, 713475, 713476, 713479, 713481, 713485, 713486, 713487, 713488, 713490, 713492, 713494, 713495, 713496, 713497, 713499, 713503, 713504, 713505, 713507, 713509, 713510, 713518, 713522, 713523, 713524, 713529, 713531, 713532, 713534, 713539, 713540, 713550, 713551, 713552, 713554, 713556, 713558, 713559, 713561, 713563, 713564, 713565, 713566, 713567, 713568, 713569, 713570, 713572, 713575, 713576, 713578, 713579, 713580, 713583, 713584, 713586, 713587, 713590, 713591, 713613, 713615, 713616, 713617, 713619, 713620, 713622, 713623, 713635, 713638, 713639, 713640, 713643, 713655, 713656, 713657, 713659, 713661, 713662, 713664, 713665, 713667, 713668, 713670, 713671, 713672, 713673, 713676, 713677, 713681, 713683, 713686, 713687, 713689, 713694, 713697, 713698, 713702, 713705, 713706, 713707, 713708, 713709, 713712, 713714, 713716, 713717, 713724, 713727, 713729, 713730, 713733, 713735, 713739, 713741, 713742, 713743, 713746, 713749, 713750, 713753, 713756, 713758, 713760, 713763, 713767, 713768, 713771, 713773, 713774, 713775, 713776, 713777, 713779, 713780, 713781, 713782, 713786, 713787, 713788, 713789, 713790, 713791, 713792, 713794, 713795, 713797, 713798, 713801, 713802, 713803, 713805, 713806, 713807, 713808, 713809, 713813, 713814, 713815, 713816, 713817, 713820, 713822, 713823, 713824, 713825, 713827, 713828, 713829, 713830, 713831, 713832, 713833, 713849, 713853, 713858, 713859, 713863, 713866, 713971, 713988, 714040, 714046, 714050, 714055, 714056, 714058, 714060, 714061, 714085, 714096, 714104, 714107, 714111, 719820, 719959, 719960, 719965, 719970, 719977, 720008, 720013, 720015, 720026, 720030, 720034, 720037, 720040, 720123, 720239, 720278 b) L301, Serial Numbers: 100547, 100752, 100822, 100829, 100843, 100845, 100846, 100850, 100852, 100853, 100857, 100863, 100865, 100866, 100867, 100868, 100869, 100870, 100871, 100874, 100875, 100876, 100878, 100879, 100881, 100883, 100884, 100889, 100890, 100891, 100892, 100893, 100894, 100895, 100896, 100897, 100899, 100900, 100903, 100904, 100911, 100912, 100913, 100914, 100915, 100916, 100919, 100920, 100921, 100923, 100925, 100926, 100927, 100928, 100929, 100930, 100931, 100932, 100936, 100937, 100938, 100939, 100940, 100941, 100942, 100944, 100946, 100947, 100948, 100949, 100950, 100952, 100955, 100956, 100957, 100958, 100959, 100960, 100962, 100964, 100967, 100968, 100969, 100970, 100971, 100972, 100973, 100975, 100976, 100977, 100979, 100980, 100981, 100982, 100983, 100985, 100986, 100988, 100989, 100990, 100991, 100993, 100994, 100995, 100996, 100997, 100999, 101000, 101002, 101003, 101004, 101006, 101008, 101009, 101010, 101011, 101012, 101014, 101015, 101016, 101017, 101018, 101020, 101021, 101022, 101024, 101025, 101032, 101033, 101034, 101036, 101037, 101039, 101040, 101042, 101043, 101044, 101046, 101048, 101050, 101052, 101053, 101059, 101060, 101061, 101063, 101064, 101065, 101066, 101067, 101068, 101069, 101072, 101073, 101074, 101075, 101076, 101078, 101080, 101082, 101083, 101086, 101087, 101088, 101089, 101090, 101091, 101092, 101093, 101096, 101097, 101098, 101099, 101101, 101103, 101104, 101105, 101106, 101108, 101109, 101110, 101111, 101113, 101114, 101118, 101120, 101122, 101125, 101126, 101127, 101129, 101130, 101131, 101132, 101133, 101134, 101135, 101136, 101137, 101138, 101140, 101141, 101142, 101143, 101144, 101148, 101149, 101152, 101153, 101154, 101155, 101157, 101158, 101159, 101161, 101165, 101170, 101173, 101174, 101176, 101177, 101178, 101179, 101180, 101181, 101182, 101184, 101185, 101186, 101187, 101190, 101191, 101193, 101200, 101202, 101207, 101208, 101209, 101210, 101211, 101214, 101218, 101221, 101223, 101224, 101225, 101227, 101228, 101229, 101231, 101233, 101234, 101235, 101236, 101238, 101242, 101243, 101244, 101245, 101246, 101247, 101249, 101251, 101254, 101258, 101261, 101262, 101263, 101264, 101267, 101268, 101270, 101271, 101272, 101274, 101275, 101276, 101279, 101283, 101285, 101286, 101288, 1012… (truncated, 533506 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 June 3, 2021

HeartWare HVAD Pump Implant Kit, REF 1125

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
Full report

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

Recall #:
88197
Lot/product code:
GTIN: 00888707000222, 00888707007641, 00888707005685 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Driveline Extension Cable, REF 100

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
Full report

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

Recall #:
88197
Lot/product code:
GTIN: 00888707009294, 00888707000345, 00763000187651 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Pump Implant Kit, REF 1153

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
Full report

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

Recall #:
88197
Lot/product code:
GTIN: 00888707000147 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Implant Kit, REF 1104JP

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
Full report

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

Recall #:
88197
Lot/product code:
GTIN: 00888707005838 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Driveline Extension Cable, REF 100US

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
Full report

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

Recall #:
88197
Lot/product code:
GTIN: 00888707000024 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Pump Accessories, REF MCS1753AK

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
Full report

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

Recall #:
88197
Lot/product code:
GTIN: 00888707005371, 00888707007597 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Outflow Graft, REF MCS1725OG

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
Full report

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

Recall #:
88197
Lot/product code:
GTIN: 00888707007627, 00888707007634 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

HeartWare HVAD Implant Kit, REF MCS1705PU

Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

ALL 50 STATES
Full report

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

Recall #:
88197
Lot/product code:
GTIN: 00888707005715, 00888707007160, 00888707007139, 00888707005364, 00888707009041 All serial numbers
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 3, 2021

Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

ALL 50 STATES
Full report

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

Recall #:
88087
Lot/product code:
a) L200, Serial Numbers: 464370, 464446, 464458, 464460, 464462, 464468, 464470, 464475, 464481, 464482, 464483, 464490, 464498, 464500, 464508, 464512, 464516, 464519, 464526, 464528, 464532, 464563, 464590, 705134, 705580, 705587, 705711, 705751, 706215, 708261, 708589, 708797, 708798, 708802, 708815, 708819, 708820, 708832, 708841, 708843, 708844, 708848, 708851, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 708896, 708907, 708910, 708913, 708914, 708917, 708923, 708928, 708932, 708933, 708935, 708936, 708937, 708938, 708940, 708941, 708943, 708956, 708958, 708963, 708974, 708977, 708981, 708982, 708986, 708987, 709002, 709004, 709006, 709007, 709008, 709013, 709016, 709027, 709033, 709034, 709039, 709042, 709044, 709045, 711776, 711780, 711795, 711804, 711814, 711823, 711839, 711852, 711866, 711868, 711875, 711893, 711894, 711899, 711914, 711917, 711925, 711938, 711947, 711954, 711971, 711997, 712053, 712056, 712084, 712086, 712088, 712093, 712098, 712125, 712129, 712131, 712174, 712177, 712178, 712219, 712232, 712239, 712249, 712257, 712279, 712284, 712286, 712290, 712350, 712352, 712385, 712390, 712410, 712414, 712428, 712436, 712442, 712449, 712470, 712475, 712489, 712491, 712521, 712537, 712571, 712598, 712631, 712848, 713367, 714102, 714105, 714785, 719943, 720012, 720109, 720110, 720119, 720142, 720228, 464359, 464382, 464387, 464388, 464444, 464447, 464452, 464457, 464467, 464471, 464473, 464477, 464486, 464491, 464492, 464501, 464505, 464506, 464511, 464514, 464517, 464521, 464523, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464568, 464570, 464576, 464694, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705563, 705576, 705579, 705584, 705591, 705622, 705628, 705702, 705706, 705713, 705728, 705753, 705795, 705812, 706007, 706098, 706200, 706256, 706321, 706328, 706350, 706372, 706379, 706392, 706441, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708351, 708585, 708595, 708618, 708619, 708620, 708764, 708816, 708824, 708826, 708831, 708853, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708905, 708912, 708915, 708916, 708918, 708920, 708922, 708924, 708925, 708929, 708930, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708950, 708952, 708959, 708960, 708965, 708966, 708967, 708968, 708969, 708971, 708975, 708976, 708978, 708980, 708983, 708984, 708992, 708997, 709000, 709003, 709009, 709014, 709023, 709024, 709025, 709029, 709037, 709040, 709041, 709043, 711763, 711765, 711768, 711771, 711773, 711777, 711791, 711843, 711863, 711865, 711867, 711869, 711870, 711872, 711879, 711885, 711887, 711890, 711897, 711898, 711910, 711915, 711918, 711922, 711923, 711924, 711926, 711927, 711928, 711929, 711931, 711942, 711946, 711963, 711965, 711970, 711980, 711982, 711987, 712009, 712017, 712026, 712058, 712083, 712107, 712114, 712137, 712145, 712210, 712255, 712256, 712264, 712302, 712312, 712321, 712396, 712397, 712459, 712477, 712534, 712742, 712820, 712829, 712843, 713710, 714062, 714791, 714827, 715058, 719969, 719972, 720019, 720122, 720124, 720132, 720134, 720135, 720141, 720144, 720145, 720147, 720172, 720173, 720183, 720184, 720191, 720198, 720234, 720240, 720242, 720250, 720309. b) L201, Serial Numbers: 100197, 100197, 716267, 716291, 716760, 716845, 716997, 718600, 718990, 742235, 742270, 742333, 742343, 742359, 742372, 742390, 742461, 742514, 742556, 742588, 742625, 742754, 743187, 743229, 743329, 743535, 744054, 746443, 746451, 751482, 100140, 100164, 100165, 100174, 100181, 100186, 100221, 100243, 100282, 100287, 100290, 100401, 100407, 100410, 100707, 100750, 100827, 100838, 100839, 716162, 716208, 716288, 716289, 716290, 716309, 716419, 716421, 716423, 716424, 716426, 716435, 716605, 716629, 716641, 716715, 716750, 716759, 716769, 716779, 716803, 716836, 716868, 716990, 716994, 717000, 717009, 717034, 717040, 717053, 717070, 717077, 717083, 717098, 717099, 717108, 717118, 717124, 717153, 717156, 717166, 717182, 717189, 717197, 717248, 717250, 717274, 717302, 717306, 717310, 717314, 717369, 717378, 717413, 717491, 717504, 717525, 717533, 717570, 717577, 717583, 717593, 717600, 717653, 717700, 717816, 717877, 717878, 717885, 717896, 717906, 717917, 717931, 717963, 717978, 717991, 717994, 717996, 718005, 718021, 718137, 718242, 718418, 718492, 718494, 718504, 718528, 718552, 718558, 718601, 718605, 718608, 718617, 718627, 718630, 718631, 718640, 718659, 718667, 718668, 718672, 718675, 718676, 718680, 718683, 718697, 718705, 718711, 718713, 718716, 718733, 718743, 718747, 718748, 718762, 718775, 718778, 718784, 718794, 718801, 718805, 718806, 718807, 718820, 718831, 718833, 718852, 718860, 718868, 718881, 718882, 718883, 718890, 718892, 718893, 718894, 718896, 718900, 718901, 718908, 718914, 718915, 718931, 718972, 718979, 718989, 719003, 719014, 719016, 719045, 719948, 724869, 725647, 725651, 725749, 725774, 725775, 725787, 725949, 726012, 726021, 72602… (truncated, 181610 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 June 3, 2021

VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

ALL 50 STATES
Full report

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

Recall #:
88087
Lot/product code:
a) U225, Serial Numbers: 707340, 100094, 100142, 100152, 100160, 100184, 100309, 100364, 100807, 100880, 100908, 100913, 700015, 700197, 700469, 700559, 700563, 700576, 700586, 700598, 700613, 700655, 700681, 700682, 700722, 700725, 700782, 700824, 700895, 700942, 700961, 700998, 701017, 701030, 701045, 701094, 701118, 701127, 701212, 701230, 701264, 701336, 701339, 701343, 701407, 701477, 701504, 702448, 702462, 702471, 702654, 702673, 702685, 702809, 703137, 703696, 703697, 703784, 703827, 703875, 703883, 703998, 707324, 707337, 707338, 707347, 707348, 707398, 707430, 707477, 707502, 707503, 707505, 707510, 707511, 707512, 707522, 707524, 707538, 707546, 707566, 707587, 707590, 707597, 100016, 100021, 100023, 100048, 100053, 100059, 100060, 100061, 100064, 100065, 100070, 100072, 100073, 100075, 100077, 100082, 100087, 100088, 100089, 100090, 100093, 100097, 100098, 100100, 100101, 100103, 100105, 100107, 100108, 100109, 100113, 100114, 100115, 100116, 100117, 100118, 100120, 100121, 100122, 100123, 100125, 100126, 100128, 100129, 100130, 100131, 100134, 100135, 100137, 100138, 100140, 100143, 100144, 100145, 100147, 100151, 100153, 100154, 100155, 100156, 100161, 100168, 100169, 100170, 100172, 100173, 100174, 100176, 100181, 100183, 100185, 100186, 100187, 100190, 100191, 100195, 100196, 100197, 100198, 100233, 100238, 100241, 100252, 100266, 100269, 100271, 100273, 100276, 100278, 100282, 100289, 100293, 100296, 100304, 100312, 100313, 100316, 100388, 100395, 100398, 100424, 100428, 100471, 100543, 100545, 100579, 100581, 100595, 100602, 100604, 100610, 100616, 100627, 100712, 100717, 100720, 100734, 100747, 100787, 100800, 100804, 100806, 100810, 100819, 100827, 100828, 100832, 100834, 100835, 100845, 100849, 100850, 100851, 100852, 100853, 100856, 100858, 100865, 100874, 100879, 100887, 100888, 100889, 100890, 100892, 100894, 100895, 100900, 100901, 100902, 100905, 100906, 100907, 100909, 100915, 100916, 100917, 100919, 100921, 100922, 100923, 100924, 100926, 100928, 100929, 100930, 100931, 100932, 100933, 100934, 100935, 700002, 700006, 700013, 700016, 700021, 700024, 700025, 700027, 700035, 700039, 700040, 700043, 700044, 700047, 700048, 700052, 700056, 700060, 700063, 700064, 700067, 700071, 700075, 700077, 700080, 700082, 700083, 700084, 700085, 700088, 700089, 700092, 700094, 700099, 700100, 700102, 700103, 700104, 700105, 700108, 700109, 700110, 700115, 700121, 700125, 700128, 700132, 700134, 700138, 700142, 700145, 700146, 700148, 700151, 700152, 700153, 700155, 700156, 700157, 700159, 700160, 700165, 700170, 700180, 700188, 700189, 700198, 700202, 700203, 700205, 700206, 700209, 700210, 700211, 700214, 700215, 700216, 700217, 700221, 700222, 700225, 700246, 700249, 700268, 700271, 700274, 700278, 700279, 700281, 700285, 700288, 700291, 700292, 700389, 700425, 700427, 700428, 700429, 700430, 700431, 700432, 700433, 700434, 700435, 700446, 700447, 700448, 700449, 700450, 700451, 700452, 700453, 700454, 700455, 700457, 700458, 700459, 700461, 700462, 700463, 700464, 700465, 700467, 700468, 700470, 700471, 700472, 700473, 700474, 700475, 700476, 700477, 700478, 700479, 700480, 700481, 700482, 700483, 700484, 700485, 700486, 700487, 700490, 700491, 700492, 700493, 700494, 700495, 700496, 700497, 700498, 700499, 700500, 700503, 700504, 700506, 700508, 700510, 700511, 700512, 700513, 700514, 700515, 700516, 700522, 700523, 700524, 700525, 700526, 700527, 700528, 700529, 700530, 700531, 700532, 700533, 700534, 700535, 700536, 700537, 700538, 700540, 700541, 700542, 700543, 700544, 700545, 700546, 700547, 700548, 700549, 700550, 700551, 700553, 700555, 700558, 700560, 700561, 700562, 700564, 700566, 700567, 700568, 700570, 700571, 700572, 700573, 700574, 700575, 700577, 700578, 700579, 700580, 700581, 700583, 700584, 700585, 700587, 700588, 700590, 700591, 700592, 700593, 700594, 700595, 700596, 700597, 700599, 700600, 700603, 700604, 700605, 700606, 700607, 700608, 700609, 700610, 700611, 700612, 700614, 700615, 700616, 700617, 700620, 700622, 700623, 700624, 700625, 700626, 700627, 700628, 700629, 700631, 700632, 700633, 700635, 700636, 700637, 700639, 700640, 700641, 700642, 700643, 700644, 700645, 700647, 700648, 700651, 700652, 700653, 700654, 700658, 700659, 700660, 700661, 700663, 700664, 700665, 700666, 700667, 700668, 700670, 700671, 700672, 700673, 700674, 700676, 700677, 700679, 700680, 700683, 700684, 700686, 700687, 700688, 700689, 700690, 700691, 700693, 700694, 700695, 700696, 700698, 700699, 700704, 700705, 700710, 700711, 700712, 700714, 700715, 700716, 700717, 700718, 700719, 700720, 700723, 700724, 700727, 700728, 700729, 700730, 700731, 700732, 700733, 700734, 700736, 700737, 700739, 700740, 700741, 700742, 700743, 700745, 700748, 700749, 700750, 700751, 700752, 700753, 700754, 700755, 700756, 700757, 700758, 700760, 700761, 700764, 700766, 700767, 700768, 700770, 700772, 700773, 700774, 700775, 700776, 700778, 700779, 700780, 700781, 700783, 700785, 700788, 700789, 700790, 700791… (truncated, 47436 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 June 3, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

ALL 50 STATES
Full report

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

Recall #:
88107
Lot/product code:
a) J274, Serial Numbers: 100000, 100001, 100005, 100008, 100009, 100010, 100016, 100017, 100019, 100021, 100026, 100028, 100031, 100032, 100033, 100034, 100036, 100037, 100038, 100041, 100042, 100044, 100045, 100046, 100047, 100049, 100051, 100052, 100055, 100056, 100057, 100060, 100062, 100075, 100084, 100088, 100095, 100098, 100100, 100101, 100102, 100103, 100106, 100107, 100109, 100112, 100114, 100115, 100116, 100118, 100120, 100121, 395016, 100012, 100013, 100018, 100020, 100029, 100030, 100043, 100054, 100065, 100105, 100117, 394733, 394736, 394741, 394742, 394743, 394745, 394746, 394747, 394748, 394749, 394750, 394751, 394752, 394753, 394754, 394755, 394756, 394757, 394758, 394759, 394762, 394763, 394764, 394765, 394766, 394767, 394768, 394769, 394770, 394771, 394772, 394773, 394774, 394775, 394776, 394777, 394778, 394779, 394780, 394781, 394782, 394783, 394784, 394785, 394786, 394787, 394788, 394789, 394790, 394791, 394792, 394793, 394794, 394795, 394796, 394797, 394798, 394799, 394800, 394801, 394802, 394803, 394804, 394805, 394806, 394807, 394808, 394809, 394810, 394811, 394812, 394813, 394814, 394815, 394816, 394817, 394818, 394819, 394820, 394821, 394825, 394826, 394827, 394828, 394829, 394830, 394831, 394832, 394833, 394834, 394835, 394836, 394837, 394838, 394839, 394840, 394841, 394842, 394843, 394844, 394845, 394846, 394847, 394848, 394849, 394850, 394851, 394852, 394853, 394854, 394855, 394856, 394857, 394858, 394859, 394860, 394861, 394862, 394863, 394864, 394865, 394866, 394867, 394868, 394869, 394870, 394871, 394874, 394875, 394876, 394877, 394878, 394879, 394880, 394882, 394883, 394884, 394885, 394886, 394887, 394888, 394890, 394891, 394892, 394893, 394894, 394895, 394896, 394897, 394898, 394899, 394900, 394901, 394902, 394903, 394905, 394906, 394907, 394908, 394909, 394910, 394911, 394912, 394915, 394916, 394917, 394918, 394919, 394920, 394921, 394922, 394923, 394924, 394925, 394926, 394927, 394928, 394929, 394931, 394932, 394933, 394934, 394935, 394936, 394937, 394938, 394939, 394940, 394941, 394942, 394943, 394944, 394945, 394946, 394947, 394948, 394949, 394950, 394951, 394952, 394953, 394954, 394955, 394956, 394957, 394958, 394959, 394960, 394961, 394962, 394963, 394964, 394965, 394966, 394967, 394968, 394969, 394970, 394971, 394972, 394973, 394974, 394975, 394976, 394977, 394978, 394979, 394980, 394981, 394982, 394983, 394984, 394985, 394986, 394987, 394988, 394989, 394990, 394991, 394992, 394993, 394994, 394995, 394996, 394997, 394998, 394999, 395000, 395001, 395002, 395003, 395004, 395005, 395006, 395007, 395008, 395009, 395010, 395011, 395013, 395014, 395017, 395018, 395019, 395020, 395022, 395023, 395024, 395025, 395026, 395027, 395028, 395029, 395030, 395031, 395032, 395033, 395034, 395035, 395036, 395037, 395038, 395039, 395040, 395041 b) J277, Serial Numbers: 101302, 104161, 100001, 100002, 100003, 100005, 100007, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100016, 100020, 100021, 100022, 100024, 100025, 100027, 100028, 100029, 100030, 100031, 100033, 100034, 100035, 100037, 100039, 100040, 100041, 100042, 100044, 100045, 100047, 100049, 100051, 100052, 100057, 100061, 100062, 100071, 100108, 100111, 100130, 100143, 100158, 100240, 100248, 100277, 100313, 100330, 100417, 100421, 100427, 100445, 100450, 100452, 100457, 100475, 100486, 100494, 100516, 100553, 100555, 100563, 100576, 100611, 100686, 100736, 100749, 100779, 100780, 100807, 100839, 100864, 100886, 100916, 100923, 100964, 100969, 100983, 100988, 101018, 101042, 101062, 101073, 101093, 101122, 101157, 101302, 101305, 101322, 101420, 101437, 101452, 101502, 101672, 101766, 101793, 101797, 101915, 101929, 102052, 102080, 102137, 102218, 102276, 102310, 102315, 102335, 102368, 102395, 102428, 102475, 102496, 102506, 102526, 102542, 102553, 102554, 102573, 102576, 102589, 102606, 102647, 102653, 102654, 102672, 102703, 102710, 102767, 102793, 102805, 102842, 102853, 102961, 103001, 103029, 103032, 103159, 103221, 103235, 103259, 103391, 103410, 103483, 103506, 103531, 103551, 103743, 103758, 103820, 103838, 103890, 103930, 104056, 104058, 104090, 104161, 104187, 104246, 104358, 104422, 104487, 104502, 104796, 104798, 104802, 104855, 104872, 104957, 104985, 105136, 105167, 105234, 431078, 431204, 431361, 431408, 431427, 431438, 431482, 431505, 431506, 431550, 431599, 431717, 431749, 431962, 432068, 432161, 432171, 432210, 432250, 432425, 432446, 432569, 432590, 432693, 432878, 432907, 432916, 432986, 433029, 433058, 433075, 433247, 433258, 433268, 433288, 433301, 433376, 433436, 433447, 433448, 433450, 433452, 433453, 433454, 433455, 433456, 433457, 433458, 433460, 433462, 433464, 433469, 433479, 433489, 100070, 100072, 100073, 100074, 100075, 100076, 100078, 100079, 100080, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100109, 100110, 100112, 10011… (truncated, 132635 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 June 3, 2021

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

ALL 50 STATES
Full report

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

Recall #:
88107
Lot/product code:
a) V272, Serial Numbers: 100002, 100014, 100017, 100021, 100028, 100037, 100048, 100052, 100053, 100054, 100065, 100067, 100068, 100075, 100077, 100080, 100092, 100093, 100096, 100097, 100098, 100099, 100101, 100104, 100106, 100107, 100108, 100114, 100116, 100118, 100119, 100120, 100124, 100127, 100136, 100152, 100153, 100155, 100159, 100161, 100162, 100165, 100168, 100170, 100171, 100173, 100175, 100176, 100179, 100194, 100195, 100199, 100201, 100202, 100203, 100205, 100206, 100211, 100212, 100216, 100218, 100219, 100221, 100224, 100226, 100227, 100228, 100230, 100232, 100233, 100237, 100238, 100240, 100241, 100242, 100245, 100247, 100249, 100250, 100253, 100256, 100257, 100258, 100261, 100266, 100270, 100272, 100276, 100277, 100280, 100281, 100287, 100289, 100290, 604977, 604982, 604984, 604986, 604987, 604988, 604991, 604992, 604998, 604999, 605002, 605003, 605004, 605005, 605006, 605007, 605009, 605010, 605011, 605013, 605014, 605015, 605017, 605020, 605021, 605022, 605023, 605025, 605026, 605027, 605028, 605029, 605035, 605036, 605037, 605039, 605041, 605047, 605049, 605051, 605052, 605055, 605057, 605058, 605061, 605062, 605063, 605064, 605065, 605070, 605073, 605075, 605076, 605079, 605080, 605082, 605085, 605087, 605088, 605090, 605096, 605098, 605099, 605100, 605103, 605108, 605112, 605115, 605117, 605118, 605120, 605124, 605127, 605128, 605129, 605133, 605135, 605136, 605137, 605140, 605141, 605147, 605149, 605150, 605151, 605152, 605153, 605154, 605155, 605158, 605159, 605161, 605162, 605163, 605164, 605166, 605168, 605170, 605172, 605173, 605174, 605175,   b) V273, Serial Numbers: 100001, 100002, 100006, 100007, 100013, 100014, 100015, 100017, 100019, 100030, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100042, 100044, 100045, 100046, 100047, 100048, 100049, 100054, 100056, 100057, 100058, 100060, 100062, 100066, 100067, 100069, 100071, 100072, 100076, 100083, 100084, 100086, 100087, 100088, 100089, 100090, 100091, 100093, 100096, 100097, 100100, 100101, 100103, 100104, 100107, 100116, 100117, 100118, 100119, 100120, 100121, 100123, 100126, 100128, 100131, 100134, 100135, 100138, 100139, 100140, 100141, 100142, 100143, 100146, 100148, 100152, 100154, 100155, 100156, 100157, 100159, 100166, 100168, 100174, 100175, 100180, 100182, 100184, 100185, 100187, 100192, 100197, 100199, 100201, 100202, 100206, 100209, 100211, 100212, 100213, 100219, 100227, 100229, 100230, 100232, 100234, 100235, 100237, 100241, 100242, 100244, 100245, 100249, 100250, 100251, 100253, 100254, 100255, 100259, 100263, 100265, 100266, 100270, 100275, 100277, 100284, 100285, 100286, 100288, 100289, 100290, 100294, 100296, 100298, 100299, 100300, 100301, 100302, 100303, 100304, 100306, 100307, 100309, 100311, 100317, 100319, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100328, 100333, 100334, 100335, 100336, 100339, 100340, 100341, 100344, 100345, 100347, 100348, 100349, 100350, 100352, 100353, 100355, 100357, 100358, 100361, 100363, 100366, 100367, 100369, 100370, 100375, 100376, 100377, 100378, 100379, 100380, 100381, 100382, 100383, 100385, 100386, 100388, 100390, 100394, 100396, 100397, 100398, 100402, 100404, 100405, 100407, 100408, 100414, 100417, 100419, 100426, 100428, 100429, 100430, 100431, 100432, 100434, 100435, 100436, 100437, 100439, 100442, 100443, 100444, 100445, 100446, 100452, 100455, 100457, 100459, 100460, 100461, 100464, 100465, 100466, 100469, 100476, 100479, 100481, 100484, 100486, 100487, 100488, 100491, 100494, 100496, 100500, 100503, 100504, 100505, 100510, 100511, 100513, 100516, 100517, 100518, 100519, 100520, 100523, 100526, 100528, 100531, 100533, 100535, 100536, 100541, 100542, 100543, 100544, 100547, 100549, 100551, 100555, 100556, 100557, 100559, 100560, 100561, 100562, 100563, 100564, 100566, 100567, 100572, 100573, 100574, 100575, 100578, 100579, 100580, 100583, 100584, 100588, 100589, 100591, 100592, 100593, 100594, 100595, 100596, 100597, 100603, 100604, 100605, 100607, 100608.100611, 100613, 100615, 100617, 100618, 100622, 100627, 100629, 100630, 100632, 100637, 100638, 100641, 100643, 100644, 100645, 100646, 100647, 100653, 100654, 100658, 100659, 100660, 100661, 100664, 100665, 100666, 100667, 100668, 100669, 100670, 100671, 100674, 100675, 100676, 100679, 100680, 100682, 100683, 100684, 100685, 100686, 100687, 100688, 100689, 100690, 100692, 100693, 100694, 100695, 100697, 100700, 100701, 100702, 100706, 100708, 100709, 100712, 100714, 100715, 100716, 100717, 100719, 100721, 100722, 100723, 100725, 100726, 100727, 100730, 100731, 100735, 100736, 100740, 100742, 100744, 100745, 100747, 100748, 100751, 100753, 100755, 100757, 100758, 100759, 100761, 100763, 100764, 100765, 100766, 100767, 100769, 100774, 100776, 100779, 100781, 100782, 100783, 100784, 100787, 100788, 100789, 100791, 100795, 100797, 100798, 100799, 100805, 100806, 100807, 100808, 100810, 100812, 100814, 100815, 100816, 100817, 100818, 100820, 100821, 100822, 100824, 100825, 100826, 100827, 100… (truncated, 13731 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)