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Recalls affecting Puerto Rico

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

16,258 recalls found

Just announced

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

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

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IHigh risk
DrugUndeclaredRecalled March 29, 2021

Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Marketed Without An Approved NDA/ANDA: Product found to be tainted with not listed on the label tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.

ALL 50 STATES
Full report

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

Recall #:
D-0687-2021
Lot/product code:
all lots within expiry
Recalling firm:
Nuri Trading LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled March 29, 2021

Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Marketed Without An Approved NDA/ANDA: Product found to be tainted with not listed on the label tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.

ALL 50 STATES
Full report

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

Recall #:
D-0686-2021
Lot/product code:
all lots within expiry
Recalling firm:
Nuri Trading LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled March 29, 2021

Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

Marketed Without An Approved NDA/ANDA: Product found to be tainted with not listed on the label tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

ALL 50 STATES
Full report

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

Recall #:
D-0685-2021
Lot/product code:
all lots within expiry
Recalling firm:
Nuri Trading LLC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled March 29, 2021

69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC

Marketed Without An Approved NDA/ANDA: Product found to be tainted with not listed on the label tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.

ALL 50 STATES
Full report

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

Recall #:
D-0688-2021
Lot/product code:
all lots within expiry
Recalling firm:
Nuri Trading LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 30, 2021

Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

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-0354-2021
Lot/product code:
Lot #: GATCO 1805, Exp. Date 12/30/2024 Serial # 715122050894
Recalling firm:
Na Na Collection
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 30, 2021

PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

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-0353-2021
Lot/product code:
Lot #: GATCO 01671, Exp Date 12/30/2024 Serial # 728175421856
Recalling firm:
Na Na Collection
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 31, 2021

Imperial Platinum 2000, 1 capsule, UPC 718122040702

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

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-0371-2021
Lot/product code:
All
Recalling firm:
QMart
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 31, 2021

PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

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-0369-2021
Lot/product code:
All
Recalling firm:
QMart
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 31, 2021

IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

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-0368-2021
Lot/product code:
All
Recalling firm:
QMart
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 31, 2021

Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0

Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

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-0324-2021
Lot/product code:
Lot #: RX1662, RX1663, RX1664 Exp. 11/2022
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 31, 2021

Burro en Primavera, 2 capsules, UPC 638632431055

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

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-0370-2021
Lot/product code:
All
Recalling firm:
QMart
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 1, 2021

Power Wheelchair

Seat baseplate pin has broken in the field.

ALL 50 STATES
Full report

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

Recall #:
87673
Lot/product code:
Gemini PWC- Model Number: P301; Part No: P30111ARMU; Serial Numbers: MU200900398, MU200401050, MU200900415, MU200401058, MU200401064, MU200401069, MU200401067, MU200401060, MU200900417, MU200900410, MU200401059, MU200401063, MU200401068, MU200401062, MU200401056, MU200401065, MU200401055, MU200401051, MU200900404, MU200900409, MU200900399, MU200900416, MU200900405, MU200900407, MU200401061, MU200401066, MU200401054, MU200401052 Gemini PWC - Model Number: P301; Part No: P3017-ARMU; Serial Numbers: MU200700022, MU200800669, MU200700024, MU200800660, MU200800665, MU200800661, MU200800664, MU200800668, MU200800663, MU200700028, MU200700021, MU200800659, MU200800667, MU200800662, MU200700026, MU200700025, MU200700023, MU200700027 Gemini PWC - Model Number: P301; Part No: P3017-SBMU; Serial Numbers: MU200700036, MU200800671, MU200800672, MU200800675, MU200800678, MU200800674, MU200700033, MU200800676 Regal PWC Model Number: P310; Part No: P310A-ARMUB; Serial Numbers: MU200900199, MU200900881, MU200900890, MU200900204, MU200900246, MU200900247, MU200900208 Vision CF PWC Model Number: P322; Part No: P322A3ARMUB; Serial Numbers: MU200600861, MU200600524, MU200600850, MU200600529, MU200600555, MU200600871, MU200600840, MU200600863, MU200600547, MU200600014, MU200600018, MU200600022, MU200600020, MU200600267, MU200600275, MU200600256, MU200600258, MU200600272, MU200600278, MU200600264, MU200600285, MU200600281, MU200600289, MU200900844, MU200600049, MU200600007, MU200600017, MU200600001, MU200600047, MU200600036, MU200600034, MU200600844, MU200600825, MU200600826, MU200600827, MU200600050, MU200600544, MU200600545, MU200600549, MU200600527, MU200600560, MU200600531, MU200600530, MU200600537, MU200600536, MU200600546, MU200600550, MU200600554, MU200900842, MU200900849, MU200900850, MU200900845, MU200600495, MU200600501, MU200600496, MU200600494, MU200600502, MU200600513, MU200600539, MU200600503, MU200600514, MU200600504, MU200600500, MU200600538, MU200600535, MU200600026, MU200600011, MU200600042, MU200600870, MU200600862, MU200600257, MU200600265, MU200600835, MU200600851, MU200600852, MU200600866, MU200600284, MU200600004, MU200600263, MU200600269, MU200600277, MU200600286, MU200600002, MU200600003, MU200600039, MU200600035, MU200600043, MU200600019, MU200600869, MU200600864, MU200600857, MU200600860, MU200600048, MU200600045, MU200900846, MU200900843, MU200900848, MU200600838, MU200600841, MU200600831, MU200600858, MU200600259, MU200600262, MU200600509, MU200600023, MU200600290, MU200600270, MU200600859, MU200600021, MU200600512, MU200600532, MU200600009, MU200600846, MU200600839, MU200600848, MU200600830, MU200600013, MU200600542, MU200600842, MU200600518, MU200600492, MU200600024, MU200600027, MU200600040, MU200600280, MU200600853, MU200600855, MU200600854, MU200600012, MU200600038, MU200600015, MU200600558, MU200600553, MU200600559, MU200600540, MU200600548, MU200600525, MU200600497, MU200600498, MU200600528, MU200600491, MU200600493, MU200600030, MU200600543, MU200600541, MU200600505, MU200600872, MU200900847, MU200600834, MU200600833, MU200600276, MU200600028, MU200600025, MU200600873, MU200600867, MU200600868, MU200600031, MU200600865, MU200600032, MU200600033, MU200600029, MU200600287 Vision CF PWC Model Number: P322; Part No: P322A4ARMUB; Serial Numbers: MU200600082, MU200600076, MU200600089, MU200600078, MU200600087, MU200600065, MU200600067, MU200600063, MU200600093, MU200600401, MU200600305, MU200600091, MU200600075, MU200900859, MU200600097, MU200600070, MU200600315, MU200900851, MU200900860, MU200900853, MU200900861, MU200600410, MU200600389, MU200600592, MU200600590, MU200600317, MU200600293, MU200600320, MU200600295, MU200600292, MU200600064, MU200600098, MU200600068, MU200600061, MU200600085, MU200600062, MU200600096, MU200600072, MU200900855, MU200900852, MU200600321, MU200600308, MU200600298, MU200600304, MU200600069, MU200600084, MU200600299, MU200600081, MU200600066, MU200600411, MU200600071, MU200600400, MU200600090, MU200600296, MU200600312, MU200600311, MU200600301, MU200600088, MU200600316, MU200600323, MU200600306, MU200600324, MU200600325, MU200600297, MU200600303, MU200600310, MU200600094, MU200900857, MU200900856, MU200900854, MU200900858, MU200600079, MU200600099, MU200600080, MU200600092, MU200600318, MU200600313, MU200600077, MU200600095 Vision Sport PWC Model Number: P326; Part No: P326AIARMUB; Serial Numbers: TMU200401384, TMU200401397, TMU200401407, TMU200401379, TMU200401380, TMU200401298, TMU200401299, TMU200401300, TMU200401302, TMU200401305, TMU200401306, TMU200401307, TMU200401311, TMU200401314, TMU200401316, TMU200401318, TMU200401319, TMU200401320, TMU200401321, TMU200401322, TMU200401323, TMU200401324, TMU200401429, TMU200401402, TMU200401403, TMU200401405, TMU200401304, TMU200401439, TMU200401432, TMU200401381, TMU200401392, TMU200401441, TMU200401438, TMU200401417, TMU200401427, TMU200401416, TMU200401450, TMU200401297, TMU200401317, TMU200401310, TMU200401413, TM… (truncated, 43178 characters total — see the official FDA record for the full value)
Recalling firm:
Merits Holdings Co. dba Merits Health Products, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 1, 2021

Scooter

Seat baseplate pin has broken in the field.

ALL 50 STATES
Full report

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

Recall #:
87673
Lot/product code:
Pioneer 3 Scooter - Model Number: S131; Part No: S13152ARMU; Serial Numbers: MU200900928, MU200600612, MU200600610, MU200600887, MU200600621, MU200600620, MU200600619, MU200600618, MU200600608, MU200600616, MU200600609, MU200600607, MU200600615, MU200600613, MU200900930, MU200600892, MU200600874, MU200600889, MU200600877, MU200600617, MU200600888, MU200600876, MU200600883, MU200600879, MU200600885, MU200900923, MU200600886, MU200600893, MU200600890, MU200600611, MU200600875 Pioneer 3 Scooter - Model Number: S131; Part No: S13152SBMU; Serial Numbers: MU200900944, MU200900942 Pioneer 4 Scooter - Model Number: S141; Part No: S14151ARMU; Serial Numbers: MU200900956, MU200900953 Pioneer 4 Scooter - Model Number: S141; Part No: S14152ARMU; Serial Numbers: MU200800943, MU200600346, MU200600353, MU200600357, MU200800940, MU200900961, MU200801127, MU200801132, MU200800947, MU200600360, MU200800938, MU200801131, MU200600358, MU200600359, MU200600344, MU200801134, MU200600354, MU200600356, MU200600351, MU200600345, MU200600355, MU200600348, MU200801122, MU200801128, MU200900971, MU200600347, MU200600361, MU200600352, MU200600349, MU200600350, MU200800931, MU200800951, MU200800949, MU200801121, MU200800941, MU200800939, MU200800942, MU200801133, MU200801125, MU200900970, MU200801123 Pioneer 4 Scooter - Model Number: S141; Part No: S14152SBMU; Serial Numbers: MU200800952, MU200501029, MU200500382, MU200501033, MU200500381, MU200501039, MU200500363, MU200500359, MU200801161, MU200500372, MU200801157, MU200501031, MU200500364, MU200501044, MU200501042, MU200800962, MU200500378, MU200601118, MU200601123, MU200601112, MU200601110, MU200601111, MU200800957, MU200801152, MU200800976, MU200601114, MU200601121, MU200601126, MU200800975, MU200801168, MU200901022, MU200501032, MU200501046, MU200901029, MU200901020, MU200500376, MU200501028, MU200501036, MU200501041, MU200501037, MU200501040, MU200601125, MU200601120, MU200501047, MU200501038, MU200501043, MU200501034, MU200501035, MU200501030, MU200601116, MU200601117, MU200601115, MU200901004, MU200901023, MU200901007, MU200901014, MU200901008, MU200901016, MU200901000, MU200601113, MU200500365, MU200500373, MU200500371, MU200500361, MU200500374, MU200500367, MU200800973, MU200500360 Pioneer 1 Scooter - Model Number: S235; Part No: S2354-ARMUB; Serial Numbers: MU200600053, MU200600052, MU200600051, MU200600054 Pioneer 1 Scooter - Model Number: S235; Part No: S2354-SBMUB; Serial Numbers: MU200600056, MU200600058, MU200600059 Pioneer 2 Scooter - Model Number: S245; Part No: S2454-ARMUB; Serial Numbers: MU200400958, MU200400969, MU200601135, MU200400960, MU200400967, MU200400968, MU200400965, MU200400964, MU200400966, MU200400962, MU200400963 Pioneer 2 Scooter - Model Number: S245; Part No: S2454-SBMUB; Serial Numbers: MU200400975, MU200400988, MU200400979 Pioneer 9 Scooter - Model Number: S331; Part No: S331-1ARMU; Serial Numbers: MU200801178, MU200700070, MU200700075, MU200700076, MU200700069, MU200801188 Pioneer 10 Scooter - Model Number: S341; Part No: S341-1ARMU; Serial Numbers: MU200800993, MU200800992, MU200800991, MU200800994, MU200800979, MU200800977, MU200800983, MU200800989, MU200800995, MU200800990 Silverado Extreme Scooter - Model Number: S940; Part No: S940A-SDMU; Serial Numbers: MU200800528, MU200700079, MU200800531, MU200800526, MU200800535, MU200700085, MU200700081 Silverado Scooter - Model Number: S941; Part No: S941A1SVMU; Serial Numbers: MU200800538
Recalling firm:
Merits Holdings Co. dba Merits Health Products, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 6, 2021

Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan. 2. Astra family: Astra XT DR MRI SureScan, Astra XT SR MRI SureScan.

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

ALL 50 STATES
Full report

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

Recall #:
87662
Lot/product code:
all codes
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 6, 2021

PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

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-0382-2021
Lot/product code:
all lots
Recalling firm:
Hyobin LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 6, 2021

PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

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-0381-2021
Lot/product code:
all lots
Recalling firm:
Hyobin LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 6, 2021

Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Percepta family: Percepta CRT-P MRI SureScan, Percepta Quad CRT-P MRI SureScan. 2. Serena family: Serena CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan. 3. Solara family: Solara CRT-P MRI SureScan, Solara Quad CRT-P MRI SureScan.

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

ALL 50 STATES
Full report

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

Recall #:
87662
Lot/product code:
all codes
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 April 6, 2021

Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. 2090 Carelink 2. 29901 Encore

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

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Full report

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

Recall #:
87662
Lot/product code:
all codes
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 April 6, 2021

CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

ALL 50 STATES
Full report

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

Recall #:
87662
Lot/product code:
all codes
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 April 6, 2021

CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

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Full report

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

Recall #:
87654
Lot/product code:
All serial numbers
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 April 6, 2021

CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

ALL 50 STATES
Full report

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

Recall #:
87654
Lot/product code:
all serial numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled April 6, 2021

Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

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

Recall #:
D-0383-2021
Lot/product code:
all lots
Recalling firm:
Hyobin LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 7, 2021

Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

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Full report

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

Recall #:
87705
Lot/product code:
UDI: 04015630939381
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled April 7, 2021

Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

ALL 50 STATES
Full report

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

Recall #:
87705
Lot/product code:
UDI: 04015630939374
Recalling firm:
Roche Diagnostics Operations, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled April 8, 2021

Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3

Marketed without an approved NDA/ANDA: Products found to contain not listed on the label sildenafil and/ or tadalafil

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Full report

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

Recall #:
D-0642-2021
Lot/product code:
all lots
Recalling firm:
NSNY Distributor Inc
View official FDA record (opens in a new tab)