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Recalls affecting Minnesota

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

16,944 recalls found
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Just announced

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

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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.

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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

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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.

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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.

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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.

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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

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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

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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2021

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

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▸Full report

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

Recall #:
88570
Lot/product code:
Item Number (Device Identifier; Serial number(s)): 02-012-38-1009 (10885862002358; 2109242, 2109243, 2109244, 2109245, 2109246, 2109247, 2109248, 2109249, 2109250, 2109251, 2109252, 2109253, 2109254, 2109255, 2109256, 2109257, 2109258, 2109261, 2109262, 2109263, 2109265, 2109267, 2109268, 2109269, 2109270, 2109271, 2109272, 2109273, 2109274, 2328032, 2328033, 2328034, 2356324, 2356325, 2356326, 2356327, 2356328, 2356329, 2356330, 2356331, 2356332, 2356334, 2356335, 2356336, 2573198, 2573199, 2573200, 2573201, 2573202, 2573203, 2573204, 2974115, 2974116, 2974117, 2974118, 2974119, 2991806, 2991807, 2991808, 2991809, 2991810, 3628492, 3628493, 3628494, 3628496, 3628499, 3628500, 3628501, 3628502, 3628503, 3628504, 3628506, 3628508, 3628509, 3628510, 3628511, 3826220, 3826221, 3826222, 3870061, 3870062, 3870063, 3870064, 3870065, 3870066, 3870067, 3870068, 3870069, 3870070, 3873437, 3873438, 3873439, 3873440, 3873441, 3873442, 3873444, 3873445, 3873446, 3873447, 3873448, 3873449, 3873451, 3873452, 3873453, 4036097, 4036098, 4036099, 4036100, 4036101, 4036102, 4036103, 4036104, 4036105, 4036108, 4036110, 4036111, 4095990, 4095991, 4095992, 4095993, 4095994, 4095995, 4095997, 4095998, 4095999, 4096000, 4096002, 4096003, 4096004, 4291075, 4291076, 4291077, 4291078, 4291079, 4291081, 4291082, 4291083, 4291085, 4291086, 4291087, 4291088, 4291090, 4291091, 4291092, 4291094, 4291095, 4291096, 4291097, 4291098, 4291099, 4291100, 4291101, 4291102, 4291103, 4706381, 4706382, 4706383, 4706384, 4706385, 4706386, 4706387, 4706389, 4706390, 4766526, 4766527, 4766528, 4766529, 4766530, 4766531, 4766532, 4766533, 4766534, 4901264, 4901265, 4901268, 4901269, 5080411, 5080412, 5080413, 5080415, 5080416, 5080417, 5080418, 5080419, 5080420, 5977948, 5977950, 6112212, 6112218, 6112224, 6112225, 6112226, 6112227, 6112228, 6112229, 6112231, 6561879, 6561886, 6561890, 6561891, 6561892, 6561894, 6561896); 02-012-38-1011 (10885862002365; 2113460, 2113461, 2113462, 2113465, 2113466, 2113467, 2113468, 2113469, 2113470, 2113471, 2113472, 2113473, 2113474, 2113475, 2113476, 2113477, 2113478, 2113479, 2113480, 2113481, 2113483, 2113484, 2113485, 2113487, 2113488, 2256816, 2256817, 2256818, 2256819, 2256820, 2256821, 2378226, 2378227, 2378228, 2378229, 2378230, 2378231, 2378233, 2378234, 2573205, 2573206, 2573207, 2573208, 2573209, 2573210, 2573211, 2573212, 2778423, 2778424, 2778425, 2778426, 2778428, 2939331, 2939332, 2939333, 2939335, 2939337, 2939338, 2939339, 3565084, 3565085, 3565086, 3565087, 3565089, 3565091, 3565092, 3565093, 3565094, 3565095, 3565096, 3565097, 3565098, 3565099, 3565101, 3565102, 3565103, 3870053, 3870054, 3870055, 3870056, 3870058, 3870059, 3870060, 3891149, 3966070, 3966071, 3966073, 3966074, 3966075, 3966076, 3990899, 3990900, 3990901, 3990904, 3990905, 3990907, 4143249, 4143250, 4143251, 4143252, 4143253, 4143255, 4143256, 4143257, 4143258, 4143259, 4143260, 4143262, 4143263, 4143265, 4143266, 4143268, 4143269, 4143270, 4143271, 4143272, 4143273, 4143274, 4143275, 4143276, 4143277, 4476031, 4476032, 4476033, 4476034, 4476035, 4476036, 4476037, 4476038, 4476039, 4476040, 4476041, 4476043, 4476044, 4476045, 4476046, 4476047, 4476048, 4476050, 4476051, 4476052, 4476053, 4476054, 4476057, 4476060, 5236236, 5236238, 5882865, 5882867, 5882869, 5882871, 5882872); 02-012-38-1013 (10885862002372; 2112936, 2112937, 2112939, 2112942, 2112943, 2112945, 2112947, 2112948, 2112949, 2112950, 2112951, 2112952, 2112954, 2112956, 2112957, 2112959, 2112960, 2112962, 2112964, 2112966, 2362197, 2362198, 2362200, 2362205, 2362207, 2573351, 2573353, 2917120, 2917121, 2917124, 2917125, 2917126, 2917127, 2917128, 2917130, 2917131, 3615834, 3615835, 3615841, 3615842, 3826036, 3826037, 3826039, 3826041, 3826043, 3989617, 3989618, 3989619, 3989624, 4152499, 4152504, 4152505, 4152506, 4152510, 4152512, 4152514, 4152521, 5981031, 6411707); 02-012-38-1015 (10885862002389; 2112584, 2112588, 2112594, 2112596, 2112598, 2112600, 2112602, 2573354, 2573355, 2778422, 2901287, 2901289, 2901290, 2901293, 2901294, 3870048, 3870049, 3870051, 3870052, 3991107, 4120497, 4217789, 4217795, 4217813); 02-012-38-1509 (10885862178794; 3616081, 3616082, 3616083, 3616084, 3795243, 3795244, 3795245, 3795247, 3795248, 3836262, 3873433, 4310727, 4310729, 4310730, 4310731, 4310733, 4310734); 02-012-38-1511 (10885862178800; 3607850, 3662935, 3662937, 4259564, 4259566, 4259568, 4259570, 4259572); 02-012-38-1513 (10885862178817; 3873426, 4259573); 02-012-38-2009 (10885862002396; 2113395, 2113396, 2113397, 2113398, 2113399, 2113401, 2113402, 2113403, 2113404, 2113405, 2113406, 2113407, 2113408, 2113409, 2113410, 2113411, 2113412, 2113413, 2113414, 2113415, 2113416, 2113417, 2113418, 2113419, 2113420, 2113421, 2113422, 2113423, 2180482, 2180483, 2180484, 2180485, 2180486, 2180487, 2180488, 2180489, 2180490, 2180491, 2211710, 2211711, 2211712, 2211713, 2211714, 2211715, 2211716, 2211717, 2211718, 2275541, 2275542, 2275543, 2275544, 2275545, 2275546, 2288266, 2288267, 228826… (truncated, 81932 characters total — see the official FDA record for the full value)
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2021

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.

There was an increase in complaints related to tip breaks and wobble/vibration.

ALL 50 STATES
▸Full report

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

Recall #:
88586
Lot/product code:
(1) REF 1882916, GTIN/UPN 20763000041223 - Lot/serial numbers 0217968715, 0218283722, 0218283942, 0218356873, 0218356874, 0218356875, 0218623544, 0219369113, 0219501397, 0219700166, 0220118673, 0220659645, 0220784922, 0220826101, 0220826102, 0221020300, 0221118606, 0221118607, 0221118608, 0221198946, 0221198951, 0221198952, 0221430166, 0221489935, 0221611652, 0221791819, 0221791821; (2) REF 1883514, GTIN/UPN 20763000040967 - Lot/serial numbers 0218283532, 0218791333, 0219215919; (3) REF 1884013, GTIN/UPN 20763000041230 - Lot/serial numbers 0217969616, 0217969617, 0218283944, 0218572177, 0219010745, 0219110914, 0221170726, 0221603993, 0221783424, 0221791809; (4) REF 1884020, GTIN/UPN 20763000040301 - Lot/serial numbers 0219501396, 0220648062, 0220649166, 0220892207, 0221156835, 0221271500; (5) REF 1884032, GTIN/UPN 00763000036140 - Lot/serial numbers 0220057395, 0220057397; (6) REF 1884033, GTIN/UPN 00763000036447 - Lot/serial numbers 0220057389, 0220057390, 0220057392; (7) REF 1882902HRE, GTIN/UPN 00763000036720 - Lot/serial numbers 0217969607, 0218283720, 0218283721, 0219215912, 0219435041, 0221527810, 0221969518; (8) REF 1882905HRE, GTIN/UPN 00763000036782 - Lot/serial numbers 0217968718, 0217968719, 0218283717, 0218283719, 0218356097, 0218790225, 0219215913, 0220177024, 0220659109, 0220659110, 0220878176, 0221091604, 0221091605, 0221118614, 0221258284, 0221527812, 0221611654; (9) REF 1882924HRE, GTIN/UPN 00763000036744 - Lot/serial numbers 0220057236, 0220057237, 0220057238, 0220057239, 0220057241, 0220057242, 0220057243, 0220057244, 0220560777, 0220659671, 0220878169, 0221072336, 0221156836, 0221275006, 0221611653, 0221619324, 0221791822; (10) REF 1882936E, GTIN/UPN 00763000036799 - Lot/serial numbers 0218377217, 0219660525; (11) REF 1882937E, GTIN/UPN 00763000036805 - Lot/serial numbers 0218377221, 0219661147, 0221279640; (12) REF 1882979HRE, GTIN/UPN 00763000033552 - Lot/serial numbers 0217970486, 0217970490, 0218162629, 0218547894; (13) REF 1883080HRE, GTIN/UPN 00763000033989 - Lot/serial numbers 0217261083, 0217261084, 0217261085, 0218354891, 0218421177, 0218790160, 0219036457; (14) REF 1883480HRE, GTIN/UPN 00763000033996 - Lot/serial numbers 0217261083, 0217261084, 0217261085, 0218354891, 0218421177, 0218790160, 0219036457; (15) REF 1883502HRE, GTIN/UPN 00763000036713 - Lot/serial numbers 0217666178, 0217666179, 0218356088, 0218356089, 0218790221, 0219215911, 0219435040, 0220929595, 0221072335, 0221110715, 0221110717, 0221118531, 0221182357, 0221468015; (16) REF 1883506HRE, GTIN/UPN 00763000037376 - Lot/serial numbers 0217666180, 0217666181, 0217667208, 0218356103, 0218790743, 0219728474, 0220070439, 0220118669, 0220158600, 0220484568, 0221119048, 0221258278, 0221468019, 0221611257, 0221611258; (17) REF 1883512HRE, GTIN/UPN 00763000037369 - Lot/serial numbers 0218356098, 0218356099, 0218356100; (18) REF 1883516HRE, GTIN/UPN 00763000037383 - Lot/serial numbers 0217665427, 0217665428, 0217665429, 0217666173, 0217666174, 0217666175, 0217666176, 0217666177, 0218572169, 0219699597, 0219728468, 0219728469, 0219848777, 0219848778, 0219848779, 0219859949, 0220124591, 0220124592, 0220124593, 0220266094, 0220313525, 0220313606, 0220313607, 0220313608, 0220313609, 0220313610, 0220313611, 0220313612, 0220484569, 0220484570, 0220891745, 0220892206, 0221111087, 0221111089, 0221111092, 0221111093, 0221118545, 0221261887, 0221271501, 0221279626, 0221279627, 0221477061, 0221477062, 0221477063, 0221477064, 0221611647, 0221611648, 0221611649, 0221791908, 0221791910, 0221791911; (19) REF 1884005HRE, GTIN/UPN 00763000036737 - Lot/serial numbers 0217968722, 0218161789, 0218161790, 0218356090, 0218790222; (20) REF 1884030HRE, GTIN/UPN 00763000036751 - Lot/serial numbers 0219968104, 0220031839, 0220031841, 0220031842, 0220031843, 0220484572, 0220560783, 0221118618, 0221258283, 0221468017, 0221698794, 0222008093; (21) REF 1884031HRE, GTIN/UPN 00763000036768 - Lot/serial numbers 0219968105, 0220032167, 0220032168, 0220032169, 0220468850, 0220583927, 0220934514, 0221072334, 0221279641, 0221792010, 0222008095; (22) REF 1884033HRE, GTIN/UPN 00763000036775 - Lot/serial numbers 0220057245, 0220057386, 0220057387; (23) REF 1884380HR, GTIN/UPN 20763000038162 - Lot/serial numbers 0217261579, 0217261580, 0217261581, 0217261582, 0217911696, 0217911698, 0217968713, 0218283533, 0218356295, 0218356302, 0218356303, 0218356304, 0218356305, 0218356866, 0218356867, 0218356870, 0218356871, 0218356872, 0218404708, 0218404710, 0218572170, 0218572171, 0218572172, 0218572173, 0218572174, 0218572175, 0218653925, 0218655886, 0218655887, 0218655888, 0218790744, 0218790745, 0218791326, 0218791327, 0218791328, 0218791329, 0218791330, 0218791331, 0218791332, 0219215917, 0219423535, 0219488214, 0219488215, 0219488216, 0219488217, 0219488218, 0219501398, 0219501399, 0219501400, 0219501401, 0219550301, 0219556484, 0219568999, 0219569000, 0219569001, 0219594771, 0219594772, 0219594773, 0219619651, 0219632566, 0219632567, 0219679070,… (truncated, 6050 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2021

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1883080EM, Rotatable Fusion Blade, Quadcut 3.0 mm x 13 cm; (2) REF 1883480EM, Rotatable Fusion Blade, Quadcut, 3.4 mm x 13 cm; (3) REF 1884006EM, Rotatable Fusion Blade, RAD 40; (4) REF 1884012EM, Rotatable Fusion Blade, RAD 12; (5) REF 1884080EM, Rotatable Fusion Blade, Tricut, 13 cm; (6) REF 1884380EM, Rotatable Fusion Blade, Quadcut, 4.3 mm x 13 cm.

There was an increase in complaints related to tip breaks and wobble/vibration.

ALL 50 STATES
▸Full report

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

Recall #:
88586
Lot/product code:
(1) REF 1883080EM, GTIN/UPN 00763000034009, Lot/serial numbers: 0217668426, 0217668430, 0217668431, 0218547904, 0219386765, 0219387546, 0221279639, 0221597049; (2) REF 1883480EM, GTIN/UPN 00763000034016, Lot/serial numbers: 0218355352, 0218355353, 0218355354, 0218548106, 0218975242, 0218975243, 0219488206, 0219810719, 0221111103, 0221275012, 0221367934, 0221597050, 0221791924; (3) REF 1884006EM, GTIN/UPN 00763000043254, Lot/serial numbers: 0217260953, 0217260954, 0217260955, 0217260956, 0217260957, 0217260958, 0217260959, 0217969622, 0217969623, 0217969624, 0217969625, 0217970026, 0217970027, 0218162408, 0218162409, 0218282135, 0218282136, 0218282139, 0218311142, 0218311143, 0218311144, 0218311145, 0218356286, 0218356287, 0218356288, 0218356289, 0218356290, 0218356291, 0218356292, 0218975837, 0219215914, 0219215915, 0219215916, 0219715476, 0219715477, 0219811260, 0220659888, 0220804521, 0220826103, 0220878167, 0220878168, 0220929588, 0220996074, 0221199850, 0221367938, 0221477065, 0221477146, 0221586895, 0221618118, 0221791912, 0222046728, 0222046729; (4) REF 1884012EM, GTIN/UPN 00763000043247, Lot/serial numbers: 0217667211, 0217667212, 0217667213, 0217667214, 0217667215, 0217667216, 0218159075, 0218159076, 0218159077, 0218159452, 0218159453, 0218159455, 0218159456, 0218159457, 0218159458, 0218423331, 0218975832, 0219036454, 0219036455, 0219122536, 0219122537, 0221791915; (5) REF 1884080EM, GTIN/UPN 00763000033842, Lot/serial numbers: 0217258057, 0217258058, 0217258059, 0217258060, 0217258061, 0217258062, 0217258063, 0217922715, 0217922716, 0217968723, 0217968724, 0217968725, 0217969086, 0217969087, 0217969088, 0217969089, 0217969090, 0217969091, 0217969092, 0217969093, 0217969094, 0217969095, 0217969096, 0217969098, 0217969099, 0217969100, 0218351460, 0218351462, 0218351463, 0218351464, 0218351465, 0218354786, 0218354787, 0218354788, 0218354789, 0218496725, 0218569925, 0218572166, 0218572167, 0218577805, 0218578866, 0218578867, 0218578868, 0218761931, 0218761932, 0218761933, 0218761934, 0218761935, 0218761936, 0218772873, 0218795848, 0218795849, 0218795850, 0218795851, 0218962903, 0218972892, 0218972893, 0218972894, 0218972895, 0218972896, 0219090839, 0219180699, 0219214780, 0219214781, 0219214782, 0219214783, 0219214784, 0219434676, 0219488207, 0219745076, 0220804698, 0220929480, 0220929481, 0220929482, 0220929483, 0221091281, 0221111100, 0221279635, 0221430167, 0221476225, 0221477046, 0221477047, 0221477048, 0221477049, 0221477051, 0221619326, 0221619330, 0221619331, 0221619332, 0221619333, 0221619334, 0221784366, 0221786297, 0221791918, 0221805157, 0221805158, 0221824122, 0221824123; (6) REF 1884380EM, GTIN/UPN 00763000034023, Lot/serial numbers: 0217258064, 0217258065, 0217260946, 0217260947, 0217260948, 0217260949, 0217260950, 0217260951, 0217260952, 0217262726, 0218179453, 0218348413, 0218355677, 0218355678, 0218355679, 0218355680, 0218355681, 0218355682, 0218355683, 0218355684, 0218355685, 0218422557, 0218422558, 0218496125, 0218497688, 0218497689, 0218497690, 0218572168, 0218683395, 0218683396, 0218683397, 0218683398, 0218795858, 0218795859, 0218795860, 0218975828, 0218975829, 0218975830, 0219215906, 0219215907, 0219215908, 0219215910, 0219653288, 0219653289, 0219802564, 0219834731, 0219848776, 0219854757, 0219890572, 0219890573, 0220484577, 0220484578, 0220659891, 0220659896, 0220703724, 0220703986, 0220703987, 0220703988, 0220703989, 0220878170, 0220878171, 0220878172, 0220878173, 0221072337, 0221110719, 0221110720, 0221118536, 0221118537, 0221118538, 0221118539, 0221181704, 0221182518, 0221271504, 0221278671, 0221279628, 0221279629, 0221305678, 0221319087, 0221468021, 0221477059, 0221477060, 0221489745, 0221489926, 0221611261, 0221616348, 0221619315, 0221619316, 0221619317, 0221619318, 0221792011, 0221805165, 0221805386, 0221805388, 0221824447, 0221824448, 0221824449;
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2021

Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 40A2500, Nucleus Removal Angled Blade, 25 cm x 4.0 mm; (2) REF 40R2000, Nucleus Removal Set, 20 cm x 4.0 mm; (3) REF 40R2500, Nucleus Removal Set, 25 cm x 4.0 mm; (4) REF 40S2000, Nucleus Removal Straight Blade, 20 cm x 4.0 mm; (5) REF 40S2500, Nucleus Removal Straight Blade, 25 cm x 4.0 mm; (6) REF 45A2000, Nucleus Removal Angled Blade, 20 cm x 4.5 mm; (7) REF 45A2500, Nucleus Removal Angled Blade, 25 cm x 4.5 mm; (8) REF 45R2000, Nucleus Removal Set, 20 cm x 4.5 mm; (9) REF 45R2500, Nucleus Removal Set, 25 cm x 4.5 mm; (10) REF 45S2000, Nucleus Removal Straight Blade, 20 cm x 4.5 mm; (11) REF 45S2500, Nucleus Removal Straight Blade, 25 cm x 4.5 mm.

There was an increase in complaints related to tip breaks and wobble/vibration.

ALL 50 STATES
▸Full report

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

Recall #:
88586
Lot/product code:
(1) REF 40A2500, GTIN/UPN 00763000033835, Lot/serial number 0220002825; (2) REF 40R2000, GTIN/UPN 00763000033866, Lot/serial number 0218179458; (3) REF 40R2500, GTIN/UPN 00763000033798, Lot/serial number 0218299192; (4) REF 40S2000, GTIN/UPN 00763000033873, Lot/serial number 0218179459; (5) REF 40S2500, GTIN/UPN 00763000043193, Lot/serial number 0220226674; (6) REF 45A2000, GTIN/UPN 00763000033880, Lot/serial number 0220443669; (7) REF 45A2500, GTIN/UPN 00763000043223, Lot/serial number 0218323602; (8) REF 45R2000, GTIN/UPN 00763000033897, Lot/serial numbers 0218284087, 0218292178, 0218973633; (9) REF 45R2500, GTIN/UPN 00763000033811, Lot/serial number 0218297618; (10) REF 45S2000, GTIN/UPN 00763000033903, Lot/serial number 0218299193; (11) REF 45S2500, GTIN/UPN 00763000043216, Lot/serial number 0218297619.
Recalling firm:
Medtronic Xomed, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 2, 2021

REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US

Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

ALARAZCACOCTDCFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWIWV
▸Full report

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

Recall #:
88683
Lot/product code:
serial numbers 22689696 through 23569078
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 2, 2021

Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

Labeling: Incorrect Instructions

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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-0005-2022
Lot/product code:
Lot # CB21024, Exp 2/2023
Recalling firm:
RISING PHARMACEUTICALS
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 3, 2021

Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

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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-0815-2021
Lot/product code:
Lot #: UV1198
Recalling firm:
Morton Grove Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 3, 2021

Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

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-0816-2021
Lot/product code:
Lot #: UV1159
Recalling firm:
Morton Grove Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 3, 2021

Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

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-0814-2021
Lot/product code:
Lot #: UV1335; UV1352; and UV1373
Recalling firm:
Morton Grove Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2021

ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D

The devices malfunction under specific operator workflows.

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▸Full report

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

Recall #:
88501
Lot/product code:
Software versions 2.1.0-2.3.0, Serial numbers 116280503226 thru 121250000503 manufactured from 01-July-2016 thru 01-Jul-2021.
Recalling firm:
Welch Allyn Inc Mortara
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2021

cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190

False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment

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

Recall #:
88607
Lot/product code:
All lot numbers
Recalling firm:
Roche Molecular Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 7, 2021

Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

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▸Full report

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

Recall #:
88623
Lot/product code:
All Lots manufactured by Eco-Med Pharmaceutical, Inc
Recalling firm:
DJO, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 7, 2021

Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:

Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

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▸Full report

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

Recall #:
88721
Lot/product code:
Serial Numbers: 22753580
Recalling firm:
W L Gore & Associates, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 7, 2021

GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.

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Recall #:
88623
Lot/product code:
All Lots Manufactured by Eco-Med Pharmaceutical, Inc
Recalling firm:
DJO, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

There is a breach in the product packaging that renders the product non-sterile.

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Recall #:
88762
Lot/product code:
Catalog number/Model number: 383536; Batch numbers/UDI numbers: Lot: 1193055/(17)240630(10)1193055(30)80/(01)50382903835367, 2024-06-30;  Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367, 2024-06-30 Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367, 2024-06-30 Lot: 1188953: (17)240630(10)1188953(30)80/(01)50382903835367, 2024-06-30
Recalling firm:
Becton Dickinson Infusion Therapy Systems Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

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Recall #:
88651
Lot/product code:
All lots
Recalling firm:
Datascope Corp.
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UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2021

Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and Vitrification Thaw Kit (Vit Kit-Thaw) for optimal recovery of specimens. Vitrification Freeze kit (which includes the VS Vitrification Solution) are cryopreservation media intended for use in the vitrification of oocytes (MII) and pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Catalog numbers: 90133-SO Vitrification Freeze kit, contained 9x1 mL. Vitrification solution, VS, Catalog #90132. Product form: Liquid. Equilibration Solution-ES is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 7.5% (v/v) of each DMSO and ethylene glycol and 20% (v/v) Dextran Serum Supplement (DSS). Vitrification Solution-VS is a HEPES buffered solution of Medium-199 containing gentamicin sulfate, 15% (v/v) of each DMSO and ethylene glycol, 20% (v/v) DSS and 0.5 M sucrose. DSS is a protein supplement consisting of 50 mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Vit Kit-Freeze for a final concentration of 10 mg/mL HSA and 4 mg/mL Dextran. These two solutions are to be used in sequence according to the step-wise microdrop vitrification protocol. Vitrification Solution-VS Aseptically filtered. Test results reported on C of A Vit Kit -Freeze (Vitrification Freeze Kit) with Gentamycin and DSS Contains 2 x 1 mL Equilibration Solution- ES; 2 X 1 mL Vitrification Solution-VS ...90133-DCOS...RX Only...Sterile ...20YY-MM-DD

Due to a component in kit being labeled with the incorrect Expiration Date

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Recall #:
88720
Lot/product code:
Catalog number: 90133-SO Vitrification Freeze kit Lot/Unit numbers: 90132210403; UDI # 00893727002811 Product code MLQ
Recalling firm:
Fujifilm Irvine Scientific, Inc.
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