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Recalls affecting Florida

Data last updated: September 9, 2026 at 1:18 PM UTC

17,524 recalls found
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Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

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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 Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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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. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

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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

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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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)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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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

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UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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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)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

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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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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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

Martina — Mangoes

Potential contamination with Salmonella

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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 IIModerate risk
DrugRecalled November 6, 2019

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

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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-0529-2020
Lot/product code:
UI1519001-A UI1519002-A UI1519003-A UI1519004-A
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

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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-0526-2020
Lot/product code:
Lot # NBSB19001DA3; Exp FEB 2021
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

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▸Full report

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

Recall #:
D-0528-2020
Lot/product code:
RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

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-0527-2020
Lot/product code:
RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 6, 2019

Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

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-0530-2020
Lot/product code:
RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2019

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.

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

Recall #:
90484
Lot/product code:
UDI-DI (GTIN): 04046963419639
Recalling firm:
Aesculap Implant Systems LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 13, 2019

Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with patient for nursing personnel.

A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.

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

Recall #:
86647
Lot/product code:
a) 1GE512055-40: 20170042941, 20170042942, 20170042943, 20170042944, 20170042945, 20170042946, 20170043764, 20170043765, 20170043766, 20170043767, 20170043768, 20170043769, 20170043770, 20170043771, 20170043772, 20170043773, 20170043774, 20170043775  b) 1GE512055-45: 20170055478, 20170055479, 20170055480, 20170055481, 20170055482, 20170055483, 20170055484, 20170055485, 20170055486, 20170055487, 20170055488, 20170055489, 20170055490, 20170056038, 20170056039, 20170056040, 20170056041, 20170056042, 20170056043, 20170056044, 20170056045, 20170056046, 20170056047, 20170056048, 20170056049, 20170056050, 20170056051, 20170056052, 20170056053, 20170056054, 20170056055, 20170056056, 20170056527, 20170056528, 20170056529, 20170056530, 20170056531, 20170056532, 20170056533, 20170056534, 20170056535, 20170056536, 20170056537, 20170056538, 20170056539, 20170056540, 20170056541, 20170056542, 20170056543, 20170056544, 20170056545, 20170056546, 20170058170, 20170058171, 20170058172, 20170058173, 20170058174, 20170058175, 20170058176, 20170058177, 20170058178, 20170058179, 20170058180, 20170058181, 20170058182, 20170058183, 20170058184, 20170058185, 20170058186, 20170058187, 20170058188, 20170058189, 20170058190, 20170058191, 20170058192, 20170058193, 20170058194, 20170058195, 20170059025, 20170059026, 20170059027, 20170059028, 20170059029, 20170059030, 20170059031, 20170059032, 20170059033, 20170059034, 20170059035, 20170059036, 20170059037, 20170059038, 20170059039, 20170059040, 20170059041, 20170059042, 20170059043, 20170059044, 20170059045, 20170059046, 20170059047, 20170059048, 20170059049, 20170059050, 20170059316, 20170059317, 20170059318, 20170059319, 20170059320, 20170059321, 20170059322, 20170059323, 20170059324, 20170059325, 20170059326, 20170059327, 20170059328, 20170060129, 20170060130, 20170060131, 20170060132, 20170060133, 20170060134, 20170060135, 20170060136, 20170060137, 20170060138, 20170060139, 20170060140, 20170060141, 20170060142, 20170060143, 20170060144, 20170060145, 20170060146, 20170060147, 20170060148, 20170060149, 20170060150, 20170060151, 20170060152, 20170060153, 20170060154, 20170061737, 20170061738, 20170061739, 20170061740, 20170061741, 20170061742, 20170061743, 20170061744, 20170061745, 20170061746, 20170061747, 20170061748, 20170061749, 20170061750, 20170061751, 20170061752, 20170061753, 20170061754, 20170061755, 20170061756, 20170061757, 20170061758, 20170061759, 20170061760, 20170061761, 20170061762, 20170063084, 20170063085, 20170063086, 20170063087, 20170063088, 20170063089, 20170063090, 20170063091, 20170063092, 20170063093, 20170063094, 20170063095, 20170063096, 20170064049, 20170064050, 20170064051, 20170064052, 20170064053, 20170064054, 20170064055, 20170064056, 20170064057, 20170064058, 20170064059, 20170064060, 20170064061, 20170064062, 20170064063, 20170064064, 20170064065, 20170064066  c) 1GE512055-85: 20180190190, 20180190191, 20180190192, 20180190193, 20180190194, 20180190195, 20180190196, 20180190197, 20180190198, 20180190199, 20180190200, 20180190201, 20180190202, 20180190203, 20180190204, 20180190205, 20180190206, 20180190207, 20180190208, 20180190209, 20180190210, 20180190211, 20180190212, 20180190213, 20180190214, 20180190215, 20180190216, 20180190217, 20180190218, 20180190219, 20180190914, 20180190915, 20180190916, 20180190917, 20180190918, 20180190919, 20180190920, 20180190921, 20180190922, 20180190923, 20180190924, 20180190925, 20180190926, 20180190927, 20180190928, 20180190929, 20180190930, 20180190931, 20180190932, 20180190933, 20180190934, 20180190935, 20180190936, 20180190937, 20180190938, 20180190939, 20180190940, 20180190941, 20180190942, 20180190943, 20180191864, 20180191865, 20180191866, 20180191867, 20180191868, 20180191869, 20180191870, 20180191871, 20180191872, 20180191873, 20180191874, 20180191875, 20180191876, 20180191877, 20180191878, 20180191879, 20180191880, 20180191881, 20180191882, 20180191883, 20180191884, 20180191885, 20180191886, 20180191887, 20180191888, 20180191889, 20180191890, 20180191891, 20180191892, 20180191893, 20180193407, 20180193408, 20180193409, 20180193410, 20180193411, 20180193412, 20180193413, 20180193414, 20180193415, 20180193416, 20180193417, 20180193418, 20180193419, 20180193420, 20180193421, 20180193428, 20180193429, 20180193430, 20180193431, 20180193432, 20180193433, 20180193434, 20180193435, 20180193436, 20180193437, 20180193438, 20180193439, 20180193440, 20180193441, 20180193442  d) 1GE512055-95: 20170114725, 20170116005, 20170116006, 20170116007, 20170116008, 20170116009, 20170116010, 20170116011, 20170116012, 20170116013, 20170116014, 20170116015, 20170116016, 20170116017, 20170116018, 20170116019, 20170116020, 20170116021, 20170116022, 20170116023, 20170116024, 20170116025, 20170116026, 20170116027, 20170116028, 20170116029, 20170116030, 20170116031, 20170116032, 20170116033, 20170116034, 20170116035, 20170116036, 20170116037, 20170116038, 20170116039, 20170116040, 20170116041, 20170116042, 20170116043, 20170116044, 2… (truncated, 11354 characters total — see the official FDA record for the full value)
Recalling firm:
Linet Spol. S.r.o.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 13, 2019

Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

Sterile barrier system may be compromised

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

Recall #:
84352
Lot/product code:
Lot codes: 70114704, 70120471, 70123847, 70123854, 70124528, 70124693, 70127336, 70130216, 70123853, 70129395, 7011472 05, 70121444, 70123849, 70124474, 70124529, 70124694, 70127498, 70131871, 70124527, 70113694, 70120282, 70121445, 70123850, 70124525, 70124689, 70124695, 70127499, 70120470, 70124692, 70120283, 70121668, 70123852, 70124526, 70124691, 70124696, 70128623, 70122004, 70127335  UDI Code: 04037691670164
Recalling firm:
GETINGE US SALES LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 13, 2019

Lamicel 20PK 5MM INTL

Routine sterilization dose does not meet the required Sterility Assurance Level.

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

Recall #:
84332
Lot/product code:
UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 13, 2019

Lamicel 10PK 10MM INTL

Routine sterilization dose does not meet the required Sterility Assurance Level.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
84332
Lot/product code:
UDI: 20613994728917; SPONGE 2205-501EX LAMICEL 10PK 10MM INTL; 2205-501EX; Lots 9767987, 9806170
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 13, 2019

Lamicel 20PK 3MM INTL Cervical dilator

Routine sterilization dose does not meet the required Sterility Assurance Level.

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

Recall #:
84332
Lot/product code:
UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2019

S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The SMART Control stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2 mm smaller in diameter than the unconstrained diameter of the stent. The stent is equipped with 12 tantalum markers, 6 at each end, to increase the visibility of the stent under fluoroscopic imaging. The SMART Control stent system is designed to be delivered through an appropriately sized catheter sheath introducer.

Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
84228
Lot/product code:
All Lot Codes. Affected SKUs: N1020ABR, N1020BBR, N1020TBR, N1040ABR, N1040BBR, N1040EBR, N1040TBR, N1060ABR, N1060BBR, N1060EBR, N1060TBR, N1080ABR, N1080BBR, N1080EBR, N1080TBR, N6120BV, N620ABR, N620BBR, N620TBR, N640ABR, N640BBR, N640TBR, N660ABR, N660BBR, N660TBR, N680ABR, N680BBR, N680TBR, N7120BV, N720ABR, N720BBR, N720TBR, N740ABR, N740BBR, N740TBR, N760ABR, N760BBR, N760TBR, N780ABR, N780BBR, N780TBR, N8120BV, N820ABR, N820BBR, N820TBR, N840ABR, N840BBR, N840EBR, N840TBR, N860ABR,  N860BBR, N860EBR, N860TBR, N880ABR, N880BBR, N880EBR, N880TBR, N920ABR, N920BBR, N920TBR, N940ABR, N940BBR, N940TBR, N960ABR, N960BBR, N960TBR, N980ABR, N980BBR, N980TBR.
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2019

Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. The delivery systems consist mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy Borst valve. The inner shaft terminates distally in a catheter tip and originates proximally in a luer hub designed to accept a 0.018 guidewire. The delivery systems have a nominal working length of 135 cm. The self-expanding PRECISE stent is constrained within the space between the inner shaft and the outer sheath, located between distal and proximal stent makers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment the stent forms an open lattice and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1-2mm smaller in diameter than the unconstrained diameter of the stent.

Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
84228
Lot/product code:
All Lot Codes. Affected SKUs: N1020SB, N1020SB, N1020SC, N1030SB, N1030SB, N1030SC, N1040SB, N1040SB, N1040SC, N520SB, N520SC,  N530SB, N530SC, N540SB, N540SC, N620SB, N620SC, N630SB, N630SC, N640SB, N640SC, N720SB, N720SC, N730SB, N730SC, N740SB, N740SC,  N820SB, N820SB, N820SC, N830SB, N830SB, N830SC, N840SB, N840SB, N840SC, N920SB, N920SB, N920SC, N930SB, N930SB, N930SC, N940SB, N940SB, N940SC, P05020RXB, P05030RXB, P05040RXB, P0520RXCE, P0530RXCE, P0540RXCE, P06020RXB, P06030RXB, P06040RXB, P0620RXCE, P0630RXCE, P0640RXCE, P07020RXB, P07030RXB, P07040RXB, P0720RXCE, P0730RXCE, P0740RXCE, P08020RXB, P08030RXB, P08040RXB, P0820RXCE, P0830RXCE, P0840RXCE, P09020RXB, P09030RXB, P0920RXCE, P0930RXCE, P0940RXCE, P10020RXB, P1020RXCE, P1030RXCE, P1040RXCE.
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2019

Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents contain tantalum markers at each end. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stents are designed to open to a preprogrammed diameter at body temperature. There are two delivery system configurations S.M.A.R.T. CONTROL and S.M.A.R.T. The stent is contained within the outer sheath of the delivery system. Once the distal end of the delivery system reaches the treatment site, the outer sheath of the delivery system is retracted to expose the stent and start its self-expansion. For the S.M.A.R.T. CONTROL Stent System, sheath retraction is achieved by grasping the handle in a fixed position with the tuning dial held between the thumb and index fingers, and rotating the tuning dial in a clockwise direction until the distal end of the stent is visibly apposed to the vessel wall. For the S.M.A.R.T. Stent System, sheath retraction is achieved by grasping the inner shaft in a fixed position and moving the outer sheath proximally relative t the inner shaft.

Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".

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

Recall #:
84228
Lot/product code:
All Lot Codes. Affected SKUs: C06020MB, C06020MV, C06020SB, C06020SV, C06030MB, C06030MV, C06030SB, C06030SV, C06040MB, C06040MV, C06040SB, C06040SV, C06060MB, C06060MV, C06060SB, C06060SV, C06080MB, C06080MV, C06080SB, C06080SV, C06100MB, C06100MV, C06100SB, C06100SV, C07020MB, C07020MV, C07020SB, C07020SV, C07030MB, C07030MV, C07030SB, C07030SV, C07040MB, C07040MV, C07040SB, C07040SV, C07060MB, C07060MV, C07060SB, C07060SV, C07080MB, C07080MV, C07080SB, C07080SV, C07100MB, C07100MV, C07100SB, C07100SV, C08020MB, C08020MV, C08020SB, C08020SV, C08030MB, C08030MV, C08030SB, C08030SV, C08040MB, C08040MV, C08040SB, C08040SV, C08060MB, C08060MV, C08060SB, C08060SV, C08080MB, C08080MV, C08080SB, C08080SV, C08100MB, C08100MV, C08100SB, C08100SV, C09020MB, C09020MV, C09020SB, C09020SV, C09030MB, C09030MV, C09030SB, C09030SV, C09040MB, C09040MV, C09040SB, C09040SV, C09060MB, C09060MV, C09060SB, C09060SV, C09080MB, C09080MV, C09080SB, C09080SV, C09100MB, C09100MV, C09100SB, C09100SV, C10020MB, C10020MV, C10020SB, C10020SV, C10030MB, C10030MV, C10030SB, C10030SV, C10040MB, C10040MV, C10040SB, C10040SV, C10060MB, C10060MV, C10060SB, C10060SV, C10080MB, C10080MV, C10080SB, C10080SV, C10100MB, C10100MV, C10100SB, C10100SV, C12020MB, C12020MV, C12020SB, C12020SV, C12030MB, C12030MV, C12030SB, C12030SV, C12040MB, C12040MV, C12040SB, C12040SV, C12060MB, C12060MV, C12060SB, C12060SV, C12080MB, C12080MV, C12080SB, C12080SV, C14030MB, C14030MV, C14030SB, C14030SV, C14040MB, C14040MV, C14040SB, C14040SV, C14060MB, C14060MV, C14060SB, C14060SV, C14080MB, C14080MV, C14080SB, C14080SV.
Recalling firm:
Cardinal Health Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2019

BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.

BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.

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

Recall #:
84301
Lot/product code:
Lot: 65549
Recalling firm:
Leica Microsystems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84430
Lot/product code:
All Serial Numbers ( excluding devices with black retainer rings) ***NOT DISTRIBUTED WITHIN THE US***
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84430
Lot/product code:
All Serial Numbers ( excluding devices with black retainer rings)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84430
Lot/product code:
All Serial Numbers ( excluding devices with black retainer rings) ***NOT DISTRIBUTED WITHIN THE US***
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84430
Lot/product code:
All Serial Numbers ( excluding devices with black retainer rings)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.

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

Recall #:
84364
Lot/product code:
1) REF KB9000-01 Lot Numbers: 9798560, 49798543, 49976101, 49798578, 49976119, 50166762, 50166842, 50353058, 50353066, 50353074, 50353082, 50353091, 50353103, 50471126, 50575494, 50555223  2) REF 11-450A-00 Lot Numbers: 9798480, 50226649, 50226665, 49832318, 49976047, 50034962, 49976063, 49976071, 50167028, 50167052, 50166949, 50343909, 50353023, 50353031, 50353040, 50429112, 50465800, 50465797, 50555258, 50653675    3) REF 1150UTPP Lot Numbers: 49799386, 49843130, 49910865, 49976645, 49976637, 50166447, 50343870, 50352952, 50352961, 50352979, 50352987, 50352995, 50385594
Recalling firm:
DeRoyal Industries Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.

The products are labeled as Class II lasers. However, the level of laser radiation emitted by the distributed products may exceed the limit (1 mW) established for Class II lasers. These products would be more appropriately classified into laser Class IIIa (IEC Laser Class IIIR).

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

Recall #:
84499
Lot/product code:
The products involved are DeWALT laser distance measurers, model numbers DWO 165, DWO 1 65S, DW0330S and Stanley Fat Max FMHT77506 TLM 165. These products were produced for DeWALT and Stanley by a contract manufacturer..
Recalling firm:
STANLEY BLACK & DECKER INC.
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UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2019

LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

The abutment provided with the Implant System may be not meeting quality requirements, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.

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

Recall #:
85369
Lot/product code:
The UDI number for the affected lots are as follows:  Product Name Part #  LOCATOR Overdenture Implant, 2.4mmD x 12mmL,2.5mm Cuff 07451 Lot # L17MB; UDI Number: 00840481101496  LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 4mm Cuff 07456 Lot # Ll5PB; L166F; UDI Number: 00840481101526  LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 4mm Cuff 07465 Lot # L15H7; L15H9; UDI Number: 00840481101571  LOCATOR Overdenture Implant, 2.9mmD x 14mmL, 4mm Cuff 07467 Lot # USHA UDI Number: 00840481101595  LOCATOR Overdenture Implant, 3.4mmD x 12mmL, 4mm Cuff 07476 Lot # L17VE; UDI Number: 00840481126116
Recalling firm:
Zest Anchors LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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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-0615-2020
Lot/product code:
HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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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-0616-2020
Lot/product code:
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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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-0612-2020
Lot/product code:
AR171764A 11/2019 AR171875A 11/2019 AR171876A 11/2019 AR171981A 11/2019 AR180020C 1/2020 AR180206A 1/2020 AR180207A 1/2020 AR180208A 1/2020 AR180438A 2/2020 AR180439A 2/2020 AR180481A 3/2020 AR180482A 3/2020 AR180483A 3/2020 AR181690A 10/2020 AR181691A 10/2020 AR181806A 11/2020 AR190058A 12/2020 AR190059A 12/2020 AR190183A 1/2021 AR190184A 1/2021 AR171984A 12/2019 AR180020B 1/2020 AR180675A 4/2020 AR180868B 5/2020 AR181807A 11/2020 AR190366B 2/2021 AR171986A 12/2019 AR171987A 12/2019 AR180255A 1/2020 AR180441A 2/2020 AR180442A 2/2020 AR180559A 3/2020 AR180560A 3/2020 AR180594A 3/2020 AR180595A 3/2020 AR180829A 4/2020 AR180831A 5/2020 AR180832A 5/2020 AR180868A 5/2020 AR181807C 11/2020 AR190085A 12/2020 AR190086A 12/2020 AR190087A 12/2020 AR190124A 1/2021 AR190542B 3/2021 AR190609A 3/2021 AR190610A 3/2021 AR171875B 11/2019 AR180483B 3/2020 AR181807B 11/2020 AR190008B 12/2020 AR171763A 11/2019 AR171764B 11/2019 AR171874A 11/2019 AR171875C 11/2019 AR171877B 11/2019 AR171878B 11/2019 AR171982A 11/2019 AR171983A 12/2019 AR171985A 12/2019 AR180016A 12/2019 AR180017A 12/2019 AR180018A 12/2019 AR180019A 12/2019 AR180020A 1/2020 AR180208B 1/2020 AR180256A 1/2020 AR180291A 1/2020 AR180292A 1/2020 AR180293A 1/2020 AR180294A 2/2020 AR180295A 2/2020 AR180364A 2/2020 AR180365A 2/2020 AR180366A 2/2020 AR180367A 2/2020 AR180368A 2/2020 AR180440B 2/2020 AR180484A 3/2020 AR180485A 3/2020 AR180556A 3/2020 AR180557A 3/2020 AR180558A 3/2020 AR180596A 3/2020 AR180597A 3/2020 AR180598A 3/2020 AR180599A 3/2020 AR180675B 4/2020 AR180676A 4/2020 AR180677A 4/2020 AR180678A 4/2020 AR180679A 4/2020 AR180801A 4/2020 AR180802A 4/2020 AR180803A 4/2020 AR180869A 5/2020 AR180870A 5/2020 AR180871A 5/2020 AR180872A 5/2020 AR180994A 5/2020 AR180995A 5/2020 AR180996A 5/2020 AR180997A 6/2020 AR180998A 6/2020 AR181158A 7/2020 AR181159A 7/2020 AR181160A 7/2020 AR181161A 7/2020 AR181692A 10/2020 AR181693A 10/2020 AR181694A 10/2020 AR181709A 10/2020 AR181710A 11/2020 AR181711A 11/2020 AR181808A 11/2020 AR181809A 11/2020 AR190004A 12/2020 AR190005A 12/2020 AR190006A 12/2020 AR190007A 12/2020 AR190008A 12/2020 AR190088A 12/2020 AR190089A 12/2020 AR190090A 12/2020 AR190121A 12/2020 AR190122A 12/2020 AR190123A 12/2020 AR190125B 1/2021 AR190181A 1/2021 AR190182A 1/2021 AR190364A 2/2021 AR190365A 2/2021 AR190366A 2/2021 AR190509A 3/2021 AR190510A 3/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)