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Recalls affecting New Mexico

Data last updated: September 8, 2026 at 1:13 PM UTC

16,356 recalls found

Just announced

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

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

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-13-T, 133MV-14-T, 133MV-15-T, 133MV-16-T; STYLE 133LV-T: 133LV-11-T, 133LV-12-T, 133LV-13-T, 133LV-14-T, 133LV-15-T, 133LV-16-T; STYLE 133SV-T: 133SV-11-T, 133SV-12-T, 133SV-13-T, 133SV-14-T, 133SV-15-T, 133SV-16-T STYLE 133FX-T: 133FX-11-T, 133FX-12-T, 133FX-13-T, 133FX-14-T, 133FX-15-T, 133FX-16-T; STYLE 133MX-T: 133MX-11-T, 133MX-12-T, 133MX-13-T, 133MX-14-T, 133MX-15-T, 133MX-16-T; STYLE 133SX-T: 133SX-11-T, 133SX-12-T, 133SX-13-T, 133SX-14-T, 133SX-15-T, 133SX-16-T; Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS;    Product Code/UDI  STYLE 133FV-T: 133FV-11-T 10888628004221, 133FV-12-T 10888628004238, 133FV-13-T 10888628004245, 133FV-14-T 10888628004252, 133FV-15-T 10888628004269, 133FV-16-T 10888628004276;  STYLE 133MV-T: 133MV-11-T 10888628004405, 133MV-12-T 10888628004412, 133MV-13-T 10888628004429, 133MV-14-T 10888628004436, 133MV-15-T 10888628004443, 133MV-16-T 10888628004450;   STYLE 133LV-T: 133LV-11-T 10888628004344, 133LV-12-T 10888628004351, 133LV-13-T 10888628004368, 133LV-14-T 10888628004375, 133LV-15-T 10888628004382, 133LV-16-T 10888628004399;   STYLE 133FX-T: 133FX-11-T 10888628004283, 133FX-12-T 10888628004290, 133FX-13-T 10888628004306, 133FX-14-T 10888628004313, 133FX-15-T 10888628004320, 133FX-16-T 10888628004337;  STYLE 133MX-T: 133MX-11-T 10888628004467, 133MX-12-T 10888628004474, 133MX-13-T 10888628004481, 133MX-14-T 10888628004498, 133MX-15-T 10888628004504, 133MX-16-T 10888628004511;  STYLE 133SX-T: 133SX-11-T 10888628004580, 133SX-12-T 10888628004597, 133SX-13-T 10888628004603, 133SX-14-T 10888628004610, 133SX-15-T 10888628004627, 133SX-16-T 10888628004634;  STYLE 133SV-T: 133SV-11-T 10888628004528, 133SV-12-T 10888628004535, 133SV-13-T 10888628004542, 133SV-14-T 10888628004559, 133SV-15-T 10888628004566 133SV-16-T 10888628004573
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203, 115-222, 115-253, 115-272, 115-290, 115-322, 115-354, 115-378, 115-401, 115-435, 115-469, 115-507, 115-547, 115-586, 115-627, 115-666, 115-716; Style 120: 120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS    Product Code/UDI STYLE 110:110-090 10888628002159, 110-120 10888628002166, 110-150 10888628002173, 110-180 10888628002180, 110-210 10888628002197, 110-240 10888628002203, 110-270 10888628002210, 110-300 10888628002227, 110-330 10888628002234, 110-360 10888628002241, 110-390 10888628002258, 110-420 10888628002265, 110-450 10888628002272, 110-480 10888628002289, 110-510 10888628002296;  STYLE 115:115-150 10888628002302, 115-167 10888628002319, 115-185 10888628002326, 115-203 10888628002333, 115-222 10888628002340, 115-253 10888628002357, 115-272 10888628002364, 115-290 10888628002371, 115-322 10888628002388, 115-354 10888628002395, 115-378 10888628002401, 115-401 10888628002418, 115-435 10888628002425, 115-469 10888628002432, 115-507 10888628002449, 115-547 10888628002456, 115-586 10888628002463, 115-627 10888628002470, 115-666 10888628002487, 115-716 10888628002494;  STYLE 120:120-180 10888628002500, 120-220 10888628002517, 120-260 10888628002524, 120-300 10888628002531, 120-340 10888628002548, 120-400 10888628002555, 120-440 10888628002562, 120-500 10888628002579, 120-550 10888628002586, 120-600 10888628002593, 120-650 10888628002609;
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133P-FV: 133P-FV-11, 133P-FV-12, 133P-FV-13, 133P-FV-14, 133P-FV-15, 133P-FV-16; STYLE 133P-MV: 133P-MV-11, 133P-MV-12, 133P-MV-13, 133P-MV-14, 133P-MV-15, 133P-MV-16; STYLE 133P-LV: 133P-LV-11, 133P-LV-12, 133P-LV-13, 133P-LV-14, 133P-LV-15, 133P-LV-16; STYLE 133P-FX: 133P-FX-11, 133P-FX-12, 133P-FX-13, 133P-FX-14, 133P-FX-15, 133P-FX-16; STYLE 133P-MX:133P-MX-11,133P-MX-12, 133P-MX-13, 133P-MX-14, 133P-MX-15, 133P-MX-16; STYLE 133P-SX: 133P-SX-11, 133P-SX-12, 133P-SX-13, 133P-SX-14, 133P-SX-15, 133P-SX-16; STYLE 133P-SV: 133P-SV-11,133P-SV-12, 133P-SV-13, 133P-SV-14, 133P-SV-15, 133P-SV-16; STYLE 133P-FV-T:133P-FV-11-T, 133P-FV-12-T, 133P-FV-13-T, 133P-FV-14-T, 133P-FV-15-T, 133P-FV-16-T; STYLE 133P-MV-T: 133P-MV-11-T, 133P-MV-12-T, 133P-MV-13-T, 133P-MV-14-T, 133P-MV-15-T, 133P-MV-16-T; STYLE 133P-LV-T: 133P-LV-11-T, 133P-LV-12-T, 133P-LV-13-T, 133P-LV-14-T, 133P-LV-15-T, 133P-LV-16-T; STYLE 133P-FX-T: 133P-FX-11-T, 133P-FX-12-T, 133P-FX-13-T, 133P-FX-14-T, 133P-FX-15-T, 133P-FX-16-T; STYLE 133P-MX-T: 133P-MX-11-T, 133P-MX-12-T, 133P-MX-13-T, 133P-MX-14-T, 133P-MX-15-T, 133P-MX-16-T; STYLE 133P-SX-T: 133P-SX-11-T, 133P-SX-12-T, 133P-SX-13-T, 133P-SX-14-T, 133P-SX-15-T, 133P-SX-16-T; STYLE 133P-SV-T: 133P-SV-11-T, 133P-SV-12-T, 133P-SV-13-T, 133P-SV-14-T, 133P-SV-15-T, 133P-SV-16-T These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS;    Product Code/UDI STYLE 133P-FV:133P-FV-11 10888628009646, 133P-FV-11-T 10888628009653, 133P-FV-12 10888628009660, 133P-FV-12-T 10888628009677, 133P-FV-13 10888628009684, 133P-FV-13-T 10888628009691, 133P-FV-14 10888628009707, 133P-FV-14-T 10888628009714, 133P-FV-15 10888628009721, 133P-FV-15-T 10888628009738, 133P-FV-16 10888628009745;  STYLE 133P-MV: 133P-MV-11 10888628010000, 133P-MV-12 10888628010024, 133P-MV-13 10888628010048, 133P-MV-14 10888628010062, 133P-MV-15 10888628010086, 133P-MV-16 10888628010109;  STYLE 133P-LV:  133P-LV-11 10888628009882, 133P-LV-12 10888628009905, 133P-LV-13 10888628009929, 133P-LV-14 10888628009943, 133P-LV-15 10888628009967, 133P-LV-16 10888628009981;  STYLE 133P-FX: 133P-FX-11 10888628009769, 133P-FX-12 10888628009783, 133P-FX-13 10888628009806, 133P-FX-14 10888628009820, 133P-FX-15 10888628009844, 133P-FX-16 10888628009868;  STYLE 133P-MX: 133P-MX-11 10888628010123, 133P-MX-12 10888628010147, 133P-MX-13 10888628010161, 133P-MX-14 10888628010185, 133P-MX-15 10888628010208, 133P-MX-16 10888628010222;   STYLE 133P-SX: 133P-SX-11 10888628010369, 133P-SX-12 10888628010383, 133P-SX-13 10888628010406, 133P-SX-14 10888628010420, 133P-SX-15 10888628010444, 133P-SX-16 10888628010468;  STYLE 133P-SV: 133P-SV-11 10888628010246, 133P-SV-12 10888628010260, 133P-SV-13 10888628010284, 133P-SV-14 10888628010307, 133P-SV-15 10888628010321, 133P-SV-16 10888628010345;  STYLE 133P-FV-T: 133P-FV-11-T 10888628009653, 133P-FV-12-T 10888628009677, 133P-FV-13-T 10888628009691, 133P-FV-14-T 10888628009714, 133P-FV-15-T 10888628009738, 133P-FV-16-T 10888628009752;  STYLE 133P-MV-T: 133P-MV-11-T 10888628010017, 133P-MV-12-T 10888628010031, 133P-MV-13-T 10888628010055, 133P-MV-14-T 10888628010079, 133P-MV-15-T 10888628010093, 133P-MV-16-T 10888628010116;   STYLE 133P-LV-T: 133P-LV-11-T 10888628009899, 133P-LV-12-T 10888628009912, 133P-LV-13-T 10888628009936, 133P-LV-14-T 10888628009950, 133P-LV-15-T 10888628009974, 133P-LV-16-T 10888628009998;  STYLE 133P-FX-T: 133P-FX-11-T 10888628009776, 133P-FX-12-T 10888628009790, 133P-FX-13-T 10888628009813, 133P-FX-14-T 10888628009837, 133P-FX-15-T 10888628009851, 133P-FX-16-T 10888628009875;  STYLE 133P-MX-T: 133P-MX-11-T 10888628010130, 133P-MX-12-T 10888628010154, 133P-MX-13-T 10888628010178, 133P-MX-14-T 10888628010192, 133P-MX-15-T 10888628010215, 133P-MX-16-T 10888628010239;  STYLE 133P-SX-T: 133P-SX-11-T 10888628010376, 133P-SX-12-T 10888628010390, 133P-SX-13-T 10888628010413, 133P-SX-14-T 10888628010437, 133P-SX-15-T 10888628010451, 133P-SX-16-T 10888628010475;  STYLE 133P-SV-T: 133P-SV-11-T 10888628010253, 133P-SV-12-T 10888628010277, 133P-SV-13-T 10888628010291, 133P-SV-14-T 10888628010314, 133P-SV-15-T 10888628010338, 133P-SV-16-T 10888628010352
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-510,168-550,168-600, 168-650,168-700,168-750, 168-800; Style 363: 363LF-170, 363LF-200, 363LF-230, 363LF-260, 363LF-300, 363LF-330, 363LF-370, 363LF-410, 363LF-450, 363LF-510, 363LF-560, 363LF-620, 363LF-690; Syle 468: 468-195, 468-230, 468-270, 468-300, 468-350, 468-380, 468-450, 468-495, 468-560, 468-620 These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

ALL 50 STATES
Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS   Product Code/UDI  Product Style 163: 163-360/10888628000704;163-440/10888628000711;163-530/10888628000728;163-655/10888628000735;163-780/10888628000742   Product Style 168: 168-120/10888628000759;168-150/10888628000766;168-180/10888628000773;168-210/10888628000780;168-240/10888628000797;168-270/10888628000803;168-300/10888628000810;168-330/10888628000827;168-360/10888628000834;168-390/10888628000841;168-420/10888628000858;168-450/10888628000865;168-480/10888628000872;168-510/10888628000889;168-550/10888628000896;168-600/10888628000902;168-650/10888628000919;168-700/10888628000926;168-750/10888628000933;168-800/10888628000940  Style 363: 363LF-170/10888628000957;363LF-200/10888628000964;363LF-230/10888628000971;363LF-260/10888628000988;363LF-300/10888628000995;363LF-330/10888628001008;363LF-370/10888628001015;363LF-410/10888628001022;363LF-450/10888628001039;363LF-510/10888628001046; 363LF-560/10888628001053;363LF-620/10888628001060;363LF-690/10888628001077;  Style 468: 468-195/10888628001084;468-230/10888628001091;468-270/10888628001107;468-300/10888628001114;468-350/10888628001121;468-380/10888628001138;468-450/10888628001145;468-495/10888628001152;468-560/10888628001169;468-620/10888628001176
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2019

Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220,TRLP-235,TRLP-250, TRLP-265,TRLP-280,TRLP-300,TRLP-320,TRLP-340,TRLP-360,TRLP-400,TRLP-440,TRLP-490,TRLP-540,TRLP-590,TRLP-640; Style TRM: TRM-140,TRM-175,TRM-195,TRM-210,TRM-240,TRM-255,TRM-275,TRM-295,TRM-310,TRM-330,TRM-345,TRM-360,TRM-375TRM-405,TRM-445,TRM-485,TRM-520,TRM-560,TRM-600,TRM-640,TRM-685,TRM-755 Style TRF: TRF-180TRF-200,TRF-220,TRF-240,TRF-265,TRF-295,TRF-325,TRF-335,TRF-345,TRF-365,TRF-385,TRF-415,TRF-450,TRF-485,TRF-520,TRF-560,TRF-605,TRF-650,TRF-695,TRF-745,TRF-770; Style TRX: TRX-205,TRX-225,TRX-255,TRX-285,TRX-310,TRX-340,TRX-375,TRX-400,TRX-420,TRX-445,TRX-470,TRX-495,TRX-525,TRX-545,TRX-560,TRX-580,TRX-615,TRX-650,TRX-700,TRX-750,TRX-800; Style TSL: TSL-110, TSL-125, TSL-140, TSL-170, TSL-200, TSL-230, TSL-260, TSL-290, TSL-320, TSL-350, TSL-380, TSL-410, TSL-460, TSL-510, TSL-560, TSL-610; Style TSLP: TSLP-125, TSLP-145, TSLP-165, TSLP-190, TSLP-205, TSLP-220, TSLP-235, TSLP-250, TSLP-265, TSLP-280, TSLP-300, TSLP-320, TSLP-340, TSLP-360, TSLP-400, TSLP-440, TSLP-490, TSLP-540, TSLP-590, TSLP-640; Style TSM: TSM-140, TSM-175, TSM-195, TSM-210, TSM-240, TSM-255, TSM-275, TSM-295, TSM-310, TSM-330, TSM-345, TSM-360, TSM-375, TSM-405, TSM-445, TSM-485, TSM-520, TSM-560, TSM-600, TSM-640, TSM-685, TSM-755; Style TSF: TSF-180 TSF-200 TSF-220 TSF-240 TSF-265 TSF-295 TSF-325 TSF-335 TSF-345 TSF-365 TSF-385 TSF-415 TSF-450 TSF-485 TSF-520 TSF-560 TSF-605 TSF-650 TSF-695 TSF-745 TSF-770 Style TSX: TSX-205, TSX-225, TSX-255, TSX-285, TSX-310, TSX-340, TSX-375, TSX-400, TSX-420, TSX-445, TSX-470, TSX-495, TSX-525, TSX-545, TSX-560, TSX-580, TSX-615, TSX-650, TSX-700, TSX-750, TSX-800; Style TCL: TCL-110, TCL-125, TCL-140, TCL-170, TCL-200, TCL-230, TCL-260, TCL-290, TCL-320, TCL-350, TCL-380, TCL-410, TCL-460, TCL-510, TCL-560, TCL-610; Style TCLP: TCLP-125, TCLP-145, TCLP-165, TCLP-190, TCLP-205, TCLP-220, TCLP-235, TCLP-250, TCLP-265, TCLP-280, TCLP-300, TCLP-320, TCLP-340, TCLP-360, TCLP-400, TCLP-440, TCLP-490, TCLP-540, TCLP-590, TCLP-640; Style TCM: TCM-140, TCM-175, TCM-195, TCM-210, TCM-240, TCM-255, TCM-275 TCM-295 TCM-310, TCM-330, TCM-345, TCM-360, TCM-375, TCM-405, TCM-445, TCM-485, TCM-520, TCM-560, TCM-600, TCM-640, TCM-685, TCM-755; Style TCF: TCF-180 TCF-200 TCF-220 TCF-240 TCF-265 TCF-295 TCF-325 TCF-335 TCF-345 TCF-365 TCF-385 TCF-415 TCF-450 TCF-485 TCF-520 TCF-560 TCF-605 TCF-650 TCF-695 TCF-745 TCF-770 Style TCX: TCX-205, TCX-225, TCX-255, TCX-285, TCX-310, TCX-340, TCX-375, TCX-400 TCX-420, TCX-445, TCX-470, TCX-495, TCX-525, TCX-545, TCX-560, TCX-580, TCX-615, TCX-650, TCX-700, TCX-750, TCX-800; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

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Full report

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

Recall #:
83500
Lot/product code:
ALL LOTS  Product Code/UDI  Style TRL: TRL-125 10888628007659, TRL-140 10888628007666, TRL-170 10888628007673, TRL-200 10888628007680, TRL-230 10888628007697, TRL-260 10888628007703, TRL-290 10888628007710, TRL-320 10888628007727, TRL-350 10888628007734, TRL-380 10888628007741, TRL-410 10888628007758, TRL-460 10888628007765, TRL-510 10888628007772, TRL-560 10888628007789, TRL-610 10888628007796;   Style TRLP:TRLP-125 10888628007802, TRLP-145 10888628007819, TRLP-165 10888628007826, TRLP-190 10888628007833, TRLP-205 10888628007840, TRLP-220 10888628007857, TRLP-235 10888628007864, TRLP-250 10888628007871, TRLP-265 10888628007888, TRLP-280 10888628007895, TRLP-300 10888628007901, TRLP-320 10888628007918, TRLP-340 10888628007925, TRLP-360 10888628007932, TRLP-400 10888628007949, TRLP-440 10888628007956, TRLP-490 10888628007963, TRLP-540 10888628007970, TRLP-590 10888628007987, TRLP-640 10888628007994;   Style TRM TRM-140 10888628008007, TRM-175 10888628008014, TRM-195 10888628008021, TRM-210 10888628008038, TRM-240 10888628008045, TRM-255 10888628008052, TRM-275 10888628008069, TRM-295 10888628008076, TRM-310 10888628008083, TRM-330 10888628008090, TRM-345 10888628008106, TRM-360 10888628008113, TRM-375 10888628008120, TRM-405 10888628008137, TRM-445 10888628008144, TRM-485 10888628008151, TRM-520 10888628008168, TRM-560 10888628008175, TRM-600 10888628008182, TRM-640 10888628008199, TRM-685 10888628008205, TRM-755 10888628008212;  Style TRF: TRF-180 10888628008229, TRF-200 10888628008236, TRF-220 10888628008243, TRF-240 10888628008250, TRF-265 10888628008267, TRF-295 10888628008274, TRF-325 10888628008281, TRF-335 10888628008298, TRF-345 10888628008304, TRF-365 10888628008311, TRF-385 10888628008328, TRF-415 10888628008335, TRF-450 10888628008342, TRF-485 10888628008359, TRF-520 10888628008366, TRF-560 10888628008373, TRF-605 10888628008380, TRF-650 10888628008397, TRF-695 10888628008403, TRF-745 10888628008410, TRF-770 10888628008427;   Style TRX: TRX-205 10888628008434, TRX-225 10888628008441, TRX-255 10888628008458, TRX-285 10888628008465, TRX-310 10888628008472, TRX-340 10888628008489, TRX-375 10888628008496, TRX-400 10888628008502, TRX-420 10888628008519, TRX-445 10888628008526, TRX-470 10888628008533, TRX-495 10888628008540, TRX-525 10888628008557, TRX-545 10888628008564, TRX-560 10888628008571, TRX-580 10888628008588, TRX-615 10888628008595, TRX-650 10888628008601, TRX-700 10888628008618, TRX-750 10888628008625, TRX-800 10888628008632;  Style TSL: TSL-110 10888628033474, TSL-125 10888628033481, TSL-140 10888628033498, TSL-170 10888628033504, TSL-200 10888628033511, TSL-230 10888628033528, TSL-260 10888628033535, TSL-290 10888628033542, TSL-320 10888628033559, TSL-350 10888628033566, TSL-380 10888628033573, TSL-410 10888628033580, TSL-460 10888628033597, TSL-510 10888628033603, TSL-560 10888628033610, TSL-610 10888628033627;  Style TSLP: TSLP-125 10888628033634, TSLP-145 10888628033641, TSLP-165 10888628033658, TSLP-190 10888628033665, TSLP-205 10888628033672, TSLP-220 10888628033689, TSLP-235 10888628033696, TSLP-250 10888628033702, TSLP-265 10888628033719, TSLP-280 10888628033726, TSLP-300 10888628033733, TSLP-320 10888628033740, TSLP-340 10888628033757, TSLP-360 10888628033764 TSLP-400 10888628033771, TSLP-440 10888628033788, TSLP-490 10888628033795, TSLP-540 10888628033801, TSLP-590 10888628033818, TSLP-640 10888628033825;  Style TSM: TSM-140 10888628033832, TSM-175 10888628033849, TSM-195 10888628033856, TSM-210 10888628033863, TSM-240 10888628033870, TSM-255 10888628033887, TSM-275 10888628033894, TSM-295 10888628033900, TSM-310 10888628033917, TSM-330 10888628033924, TSM-345 10888628033931, TSM-360 10888628033948, TSM-375 10888628033955, TSM-405 10888628033962, TSM-445 10888628033979, TSM-485 10888628033986, TSM-520 10888628033993, TSM-560 10888628034006, TSM-600 10888628034013, TSM-640 10888628034020, TSM-685 10888628034037, TSM-755 10888628034044;  Style TSF: TSF-180 10888628034051, TSF-200 10888628034068, TSF-220 10888628034075, TSF-240 10888628034082, TSF-265 10888628034099, TSF-295 10888628034105, TSF-325 10888628034112, TSF-335 10888628034129, TSF-345 10888628034136, TSF-365 10888628034143, TSF-385 10888628034150, TSF-415 10888628034167, TSF-450 10888628034174, TSF-485 10888628034181, TSF-520 10888628034198, TSF-560 10888628034204, TSF-605 10888628034211, TSF-650 10888628034228, TSF-695 10888628034235, TSF-745 10888628034242, TSF-770 10888628034259;  Style TSX: TSX-205 10888628034266, TSX-225 10888628034273, TSX-255 10888628034280, TSX-285 10888628034297, TSX-310 10888628034303, TSX-340 10888628034310, TSX-375 10888628034327, TSX-400 10888628034334, TSX-420 10888628034341, TSX-445 10888628034358, TSX-470 10888628034365, TSX-495 10888628034372, TSX-525 10888628034389, TSX-545 10888628034396, TSX-560 10888628034402, TSX-580 10888628034419, TSX-615 10888628034426, TSX-650 10888628034433, TSX-700 10888628034440, TSX-750 10888628034457, TSX-800 10888628034464;  Style TCL: TCL-110 10888628030435,… (truncated, 7443 characters total — see the official FDA record for the full value)
Recalling firm:
Allergan PLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2019

Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.

Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.

ALL 50 STATES
Full report

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

Recall #:
83532
Lot/product code:
Model Number: 2082844-001;   Serial Number (UDI Number): TABY70690 (010084068211686221TABY7069011190610), TABY70692 (010084068211686221TABY7069211190611), TABY70708 (010084068211686221TABY7070811190612), TABY70719 (010084068211686221TABY7071911190613), TABY70709 (010084068211686221TABY7070911190612), TABY70724 (010084068211686221TABY7072411190614), TABY70722 (010084068211686221TABY7072211190614), TABY70718 (010084068211686221TABY7064211190603), TABY70717 (010084068211686221TABY7064411190603), TABY70712 (010084068211686221TABY7064511190603), TABY70678 (010084068211686221TABY7067811190607), TABY70725 (010084068211686221TABY7072511190615), TABY70672 (010084068211686221TABY7067211190607), TABY70686 (010084068211686221TABY7068611190610), TABY70688 (010084068211686221TABY7068811190610), TABY70697 (010084068211686221TABY7069711190611), TABY70726 (010084068211686221TABY7072611190616), TABY70729 (010084068211686221TABY7072911190616), TABY70645 (010084068211686221TABY7064711190604), TABY70647 (010084068211686221TABY7066011190605), TABY70646 (010084068211686221TABY7071211190613), TABY70644 (010084068211686221TABY7071711190613), TABY70642 (010084068211686221TABY7071811190613), TABY70732 (010084068211686221TABY7073211190617), TABY70723 (010084068211686221TABY7072311190614), TABY70747 (010084068211686221TABY7074711190619), TABY70748 (010084068211686221TABY7074811190619), TABY70673 (010084068211686221TABY7067311190607), TABY70676 (010084068211686221TABY7067611190607), TABY70693 (010084068211686221TABY7069311190611), TABY70648 (010084068211686221TABY7064811190604), TABY70675 (010084068211686221TABY7067511190607), TABY70694 (010084068211686221TABY7069411190611), TABY70695 (010084068211686221TABY7069511190611), TABY70730 (010084068211686221TABY7073011190617), TABY70734 (010084068211686221TABY7073411190617), TABY70737 (010084068211686221TABY7073711190618), TABY70677 (010084068211686221TABY7067711190607), TABY70698 (010084068211686221TABY7069811190611), TABY70699 (010084068211686221TABY7069911190611), TABY70703 (010084068211686221TABY7070311190612), TABY70706 (010084068211686221TABY7070611190612), TABY70727 (010084068211686221TABY7072711190616), TABY70728 (010084068211686221TABY7072811190616), TABY70660 (010084068211686221TABY7064611190603), TABY70689 (010084068211686221TABY7068911190610), TABY70705 (010084068211686221TABY7070511190612), TABY70707 (010084068211686221TABY7070711190612), TABY70731 (010084068211686221TABY7073111190617), TABY70733 (010084068211686221TABY7073311190617), TABY70652 (Not Available),  TABY70654 (Not Available), TABY70662 (Not Available), TABY70664 (Not Available), TABY70710 (Not Available), TABY70715 (Not Available), TABY70716 (Not Available), TABY70753 (Not Available), TABY70659 (Not Available), TABY70704 (010084068211686221TABY7070411190612),  TABY70755 (010084068211686221TABY7075511190620), TABY70638 (Not Available), TABY70649 (Not Available), TABY70656 (Not Available), TABY70661 (Not Available), TABY70657 (Not Available), TABY70650 (Not Available), TABY70667 (Not Available), TABY70668 (Not Available), TABY70653 (Not Available), TABY70663 (Not Available), TABY70670 (Not Available), TABY70665 (Not Available), TABY70669 (Not Available), TABY70671 (Not Available), TABY70714 (Not Available), TABY70658 (Not Available), TABY70655 (Not Available), TABY70666 (Not Available), TABY70651 (Not Available).
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 29, 2019

Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes.

The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.

ALL 50 STATES
Full report

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

Recall #:
85301
Lot/product code:
AS9924-00-0002, RB011-00-0005,RB011-00-0006, RB011-00-0010, RB011-00-0012, RB011-00-0015, RB011-00-0017, RB011-00-0018, RB011-00-0019, RB011-00-0020, RB011-00-0021, RB011-0022, RB011-0023, RB011-0024, RB011-0025, RB011-0026, RB011-0027, RB011-0028, RB011-0029, RB011-0030, RB011-0031, RB011-0032, RB011-0033, RB011-0034, RB011-0035, RB011-0036, RB011-0037, RB011-0038, RB011-0039, RB011-0040, RB011-0041, RB011-0042, RB011-0044, RB011-0045, RB011-0046, RB011-0047, RB011-0048, RB011-0049, RB011-0050, RB011-0051, RB011-0052, RB011-0053, RB011-0054, RB011-0055, RB011-0056, RB011-0057, RB011-0058, RB011-0059, RB011-0060, RB011-0061, RB011-0062, RB011-0063, RB011-0064, RB011-0065, RB011-0066, RB011-0067, RB011-0068, RB011-0069, RB011-0070, RB011-0071, RB011-0072, RB011-0073, RB011-0074, RB011-0075, RB011-0076, RB011-0077, RB011-0078, RB011-0079, RB011-0080, RB011-0081, RB011-0082, RB011-0083, RB011-0084, RB011-0085, RB011-0086, RB011-0087, RB011-0088, RB011-0089, RB011-0090, RB011-0091, and RB011-0092.
Recalling firm:
MOTEK MEDICAL B.V.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 30, 2019

RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Under certain conditions, a marble pattern infrequently appears on the monitor.

ALL 50 STATES
Full report

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

Recall #:
85299
Lot/product code:
RadiForce GX560 - 1.0003 or earlier
Recalling firm:
Eizo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 30, 2019

RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

Under certain conditions, a marble pattern infrequently appears on the monitor.

ALL 50 STATES
Full report

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

Recall #:
85299
Lot/product code:
RadiForce RX360, 1.0001 or earlier, UDI 04995047053279, 04995047053293.
Recalling firm:
Eizo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 1, 2019

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

ALL 50 STATES
Full report

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

Recall #:
83491
Lot/product code:
Part Numbers:   1. 7590310-24;   2. 7590310-40;   3. 7590311-24;   4. 7590311-40;   5. 7590312-24;   6. 7590312-40;   7. 7590313-24;   8. 7590313-40;   9. 7590314-24;   10. 7590314-40;   11. 7590315-24;   12. 7590315-40;   13. 7590316-24;   14. 7590316-40;   15. 7590317-24;   16. 7590317-40;   17. 7590318-24-5;   18. 7590318-24-7;   19. 7590318-40-5;   20. 7590318-40-7;   21. 7590319-24-5;   22. 7590319-40-5;   23. 7590440;   24. 7590441;   25. 7590442;   26. 7590443;   27. 7590444;   28. 7590445;   29. 7590446;   30. 7590447;   31. 7590450-5;   32. 7590450-8
Recalling firm:
GN Otometrics
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Brazo Gitano Guayaba Queso (Guava- Cheese Cake Roll); Peso Neto 12 ONZ. (340 G)

Failure to declare Soy, FD&C Yellow #5 and #6 and lack of Keep Refrigerated labeling.

ALL 50 STATES
Full report

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

Recall #:
F-2104-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Bizcocho de Guayaba y Coco (Guava-Coconut Pudding Cake); Peso Neto 14 ONZ. (397 G)

Failure to declare Sodium Metabisulfite.

ALL 50 STATES
Full report

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

Recall #:
F-2106-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2019

Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline

Samples in the identified lot were found to have incomplete or open packaging seals.

ALL 50 STATES
Full report

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

Recall #:
83551
Lot/product code:
Lot Number 19CAB954
Recalling firm:
Medline Industries Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled August 9, 2019

Vitony Bakery, Bizcocho de Queso y Guayaba (Cheese-Guava Pudding Cake); Peso Neto 14 ONZ. (397 G)

Failure to declare FD&C Yellow #5 and FD&C Yellow #6.

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

Recall #:
F-2105-2019
Lot/product code:
None in product label
Recalling firm:
Vitony Bakery, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2019

Proteus XR/a (SlOK : K993090)

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

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

Recall #:
83647
Lot/product code:
console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
Recalling firm:
GE Healthcare, LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled August 19, 2019

RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.

It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

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

Recall #:
84859
Lot/product code:
Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019
Recalling firm:
RESPIRATORY THERAPEUTICS GROUP LLC
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UnclassifiedRisk not yet known
Medical deviceRecalled August 19, 2019

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.

Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.

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

Recall #:
85324
Lot/product code:
Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

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Full report

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

Recall #:
83558
Lot/product code:
Model A219, Serial Number (Use Before Date) - 213636 (7/21/2019), 213637 (7/21/2019), 213638 (7/21/2019), 213639 (7/21/2019), 213640 (7/21/2019), 213641 (7/21/2019), 213642 (7/21/2019), 213643 (7/21/2019), 213644 (7/21/2019), 213645 (7/21/2019), 213646 (7/21/2019), 213647 (7/21/2019), 213648 (7/21/2019), 213649 (7/21/2019), 213650 (7/21/2019), 213651 (7/21/2019), 213652 (7/21/2019), 213653 (7/21/2019), 213654 (7/21/2019), 213655 (7/21/2019), 213656 (7/21/2019), 213657 (7/21/2019), 213658 (7/21/2019), 213659 (7/21/2019), 213660 (7/21/2019), 213661 (7/21/2019), 213662 (7/21/2019), 213663 (7/21/2019), 213665 (7/21/2019), 213666 (7/21/2019), 213667 (7/21/2019), 213668 (7/21/2019), 213669 (7/21/2019), 213670 (7/21/2019), 213671 (7/21/2019), 213672 (7/21/2019), 213673 (7/21/2019), 213674 (7/21/2019), 213675 (7/21/2019), 213676 (7/21/2019), 213677 (7/21/2019), 213678 (7/21/2019), 213679 (7/21/2019), 213680 (7/21/2019), 213681 (7/21/2019), 213682 (7/21/2019), 213683 (7/21/2019), 213684 (7/21/2019), 213685 (7/21/2019), 213686 (7/24/2019), 213687 (7/24/2019), 213688 (7/24/2019), 213689 (7/24/2019), 213690 (7/24/2019), 213691 (7/24/2019), 213692 (7/24/2019), 213693 (7/24/2019), 213694 (7/24/2019), 213695 (7/24/2019), 213696 (7/24/2019), 213697 (7/24/2019), 213698 (7/24/2019), 213699 (7/24/2019), 213700 (7/24/2019), 213701 (7/24/2019), 213702 (7/24/2019), 213703 (7/24/2019), 213704 (7/24/2019),  213705 (7/24/2019), 213706 (7/24/2019), 213707 (7/24/2019), 213708 (7/24/2019), 213709 (7/24/2019), 213710 (7/24/2019), 213712 (7/24/2019), 213713 (7/24/2019), 213714 (7/24/2019), 213715 (7/24/2019), 213716 (7/24/2019), 213717 (7/24/2019), 213718 (7/24/2019), 213719 (7/24/2019), 213720 (7/24/2019), 213721 (7/24/2019), 213722 (7/24/2019), 213723 (7/24/2019), 213724 (7/24/2019), 213726 (7/24/2019), 213727 (7/24/2019), 213728 (7/24/2019), 213730 (7/24/2019), 213731 (7/24/2019), 213732 (7/24/2019), 213733 (7/24/2019), 213734 (7/24/2019), 213735 (7/24/2019), 213736 (7/24/2019), 213737 (7/24/2019), 213738 (7/24/2019), 213739 (7/24/2019), 213740 (7/24/2019), 213741 (7/24/2019), 213742 (7/24/2019), 213743 (7/24/2019), 213744 (7/24/2019), 213745 (7/24/2019), 213746 (7/25/2019), 213747 (7/25/2019), 213748 (7/25/2019), 213749 (7/25/2019), 213750 (7/25/2019), 213751 (7/25/2019), 213752 (7/25/2019), 213753 (7/25/2019), 213754 (7/25/2019), 213755 (7/25/2019), 213756 (7/25/2019), 213757 (7/25/2019), 213758 (7/25/2019), 213759 (7/25/2019), 213760 (7/25/2019), 213761 (7/25/2019), 213762 (7/25/2019), 213763 (7/25/2019), 213764 (7/25/2019), 213765 (7/25/2019), 213766 (7/25/2019), 213767 (7/25/2019), 213768 (7/25/2019), 213769 (7/25/2019), 213770 (7/25/2019), 213771 (7/25/2019), 213772 (7/25/2019), 213773 (7/25/2019), 213774 (7/25/2019), 213775 (7/25/2019), 213776 (7/25/2019), 213777 (7/25/2019), 213778 (7/25/2019), 213779 (7/25/2019), 213780 (7/25/2019), 213782 (7/25/2019), 213783 (7/25/2019), 213784 (7/25/2019), 213785 (7/25/2019), 213786 (7/25/2019), 213787 (7/25/2019), 213788 (7/25/2019), 213789 (7/25/2019), 213790 (7/25/2019), 213791 (7/25/2019), 213792 (7/25/2019), 213793 (7/25/2019), 213794 (7/25/2019), 213795 (7/25/2019), 213796 (7/25/2019), 213797 (7/25/2019), 213798 (7/25/2019), 213799 (7/25/2019), 213800 (7/25/2019), 213801 (7/25/2019), 213802 (7/25/2019), 213803 (7/25/2019), 213804 (7/25/2019), 213805 (7/25/2019), 213806 (7/25/2019), 213807 (7/25/2019), 213808 (7/25/2019), 213809 (7/25/2019), 213810 (7/25/2019), 213811 (7/25/2019), 213812 (7/25/2019), 213813 (7/25/2019), 213814 (7/25/2019), 213815 (7/25/2019), 213816 (7/26/2019), 213817 (7/26/2019), 213818 (7/26/2019), 213819 (7/26/2019), 213820 (7/26/2019), 213821 (7/26/2019), 213822 (7/26/2019), 213823 (7/26/2019), 213824 (7/26/2019), 213826 (7/26/2019), 213827 (7/26/2019), 213828 (7/26/2019), 213830 (7/26/2019), 213831 (7/26/2019), 213832 (7/26/2019), 213833 (7/26/2019), 213834 (7/26/2019), 213835 (7/26/2019), 213836 (7/26/2019), 213837 (7/26/2019), 213838 (7/26/2019), 213839 (7/26/2019), 213840 (7/26/2019), 213841 (7/26/2019), 213843 (7/26/2019), 213844 (7/26/2019), 213845 (7/26/2019), 213846 (7/26/2019), 213847 (7/26/2019), 213848 (7/26/2019), 213849 (7/26/2019), 213850 (7/26/2019), 213851 (7/26/2019), 213852 (7/26/2019), 213853 (7/26/2019), 213854 (7/26/2019), 213855 (7/26/2019), 213856 (7/26/2019), 213857 (7/26/2019), 213858 (7/26/2019), 213860 (7/26/2019), 213861 (7/26/2019), 213862 (7/26/2019), 213863 (7/26/2019), 213864 (7/26/2019), 213865 (7/26/2019), 213866 (7/26/2019), 213867 (7/26/2019), 213868 (7/26/2019), 213869 (7/26/2019), 213870 (7/26/2019), 213871 (7/26/2019), 213872 (7/26/2019), 213874 (7/26/2019), 213875 (7/26/2019), 213876 (7/26/2019), 213877 (7/26/2019), 213878 (7/26/2019), 213879 (7/26/2019), 213880 (7/26/2019), 213881 (7/26/2019), 213882 (7/26/2019), 213883 (7/26/2019), 213884 (7/26/2019), 213885 (7/26/2019), 213886 (7/27/2019), 213887 (7/27/2019), 213888 (7/27/2019), 213889 (7/27/2019), 213890 (7/27/2019), 213892 (7/27/2019), 213893 (7/27/2019), 213894 (7/27/… (truncated, 8125 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

ALL 50 STATES
Full report

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

Recall #:
83558
Lot/product code:
Model A209, Serial Number (Use Before Date) - 213729 (7/24/2019), 213859 (7/26/2019), 213891 (7/27/2019), 213896 (7/27/2019), 213898 (7/27/2019), 213901 (7/27/2019), 213902 (7/27/2019), 213904 (7/27/2019), 213910 (7/27/2019), 213919 (7/27/2019), 213921 (7/27/2019), 213937 (7/27/2019), 213938 (7/27/2019), 213943 (7/27/2019), 213946 (7/27/2019), 213961 (7/28/2019), 213972 (7/28/2019), 213975 (7/28/2019), 213976 (7/28/2019), 213979 (7/28/2019), 213982 (7/28/2019), 213983 (7/28/2019), 214020 (7/31/2019), 214030 (7/31/2019), 214032 (7/31/2019), 214036 (7/31/2019), 214042 (7/31/2019), 214083 (7/31/2019);
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2019

ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

ALL 50 STATES
Full report

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

Recall #:
83813
Lot/product code:
1. Product Code: 3F, No UDI Number, Serial Numbers: M13F1043G, B23F1531G, B23F1532G, B23F2216G, A23F1290G, B23F1324G, M13F1152G, M13F1153G, M13F1154G, M13F1155G, M13F1164G, M13F1165G, M13F1166G, M13F1168G, M13F1169G, L13F0687G, D23F1925G, D23F1968G, E23F2074G, E23F2075G, B23F1402G, M13F1059G, M13F1173G, M13F1109G, C23F1815G, A23F1260G, J13F0272G, C23F1607G, D23F1981G, M13F0968G, L13F0683G, L13F0576G, J13F0274G, B23F1302G, K13F0437G, C23F1793G, D23F1943G, M13F1094G, B23F1495G, K13F0481G, L13F0571G, B23F1304G, C23F1808G, D23F1899G, M13F1151G, J13F0098G, J13F0099G, J13F0100G, C23F1594G, M13F1099G, B23F1439G, J13F0229G, L13F0600G, K13F0499G, K13F0500G, K13F0501G, L13F0623G, L13F0624G, L13F0625G, B23F13886, B23F1388G, B23F1390G, D23F1851G, D23F1861G, J13F0369G, M13F1075G, M13F1084G, M13F0891G, M13F0892G, A23F1229G, E23F2036G, L13F0776G, A23F1258G, B23F1315G, B23F1496G, B23F1501G, B23F1502G, B23F1506G, B23F1508G, C23F1784G, F13F0006G, J13F0006G, L13F0864G, L13F0865G, L13F0866G, L13F0668G, J13F0291G, J13F0292G, J13F0300G, M13F0950G, M13F1150G, B23F1313G, M13F0995G, M13F1044G, C23F1699G, J13F0293G, J13F0294G, J13F0295G, J13F0374G, J13F0375G, J13F0378G, J13F0379G, L13F0721G, L13F0729G, L13F0767G, L13F0768G, L13F0769G, M13F1062G, M13F1063G, E23F2068G, M13F1069G, D23F1852G, K13F0415G, K13F0426G, B23F1454G, D23F1971G, D23F1987G, K13F0411G, K13F0387G, L13F0755G, M13F1141G, M13F1142G, J13F0333G, J13F0203G, D23F1936G, M13F0991G, B23F1452G, B23F1509G, D23F1980G, D23F1982G, E23F2064G, J13F0308G, M13F1032G, M13F1034G, M13F1046G, M13F1047G, L13F0669G, A23F1266G, A23F1267G, A23F1297G, C23F1589G, B23F1357G, B23F1358G, M13F1074G, D23F1859G, D23F1933G, F23F2081G, F23F2090G, F23F2091G, F23F2092G, F23F2111G, A23F1263G, B23F1362G, C23F1690G, D23F1877G, D23F1888G, D23F1997G, D23F2014G, J13F0250G, J13F0252G, J13F0255G, K13F0462G, K13F0464G, K13F0518G, K13F0533G, L13F0691G, L13F0692G, L13F0741G, M13F0917G, M13F0927G, M13F0939G, M13F0972G, M13F0973G, M13F0993G, M13F0994G, M13F1033G, M13F1045G, M13F1048G, M13F1051G, M13F1070G, M13F1106G, M13F1107G, M13F1108G, M13F1114G, M13F1146G, D23F1867G, L13F0631G, C23F1809G, D23F1835G, L13F0607G, C23F1777G, J13F0222G, J13F0219G, C23F1800G, C23F1801G, C23F1802G, J13F0072G, B23F1346G, B23F1347G, B23F1348G, D23F1853G, M13F1073G, D23F1854G, D23F1855G, D23F1856G, B23F1516G, B23F1526G, B23F1527G, C23F1649G, C23F1779G, K13F0566G, J13F0245G, M13F0940G, D23F1958G, E23F2079G, E23F2072G, K13F0431G, K13F0432G, K13F0435G, K13F0563G, K13F0564G, K13F0565G, A23F1250G, A23F1257G, B23F1316G, J13F0313G, J13F0314G, J13F0315G, A23F1246G, A23F1249G, C23F1728G, C23F1757G, D23F1994G, M13F1040G, L13F0616G, L13F0861G, J13F0273G, A23F1282G, K13F0475G, C23F1767G, C23F1769G, C23F1770G, C23F1772G, D23F1846G, J13F0367G, J13F0368G, D23F1946G, B23F1510G, B23F1512G, B23F1513G, B23F1517G, B23F1521G, B23F1529G, B23F1530G, B23F1534G, B23F1539G, B23F1544G, C23F1725G, C23F1726G, K13F0524G, L13F0724G, L13F0730G, A23F1196G, A23F1198G, B23F1473G, L13F0809G, L13F0810G, L13F0811G, L13F0813G, L13F0814G, C23F1817G, C23F1818G, D23F1839G, M13F0949G, J13F0048G, J13F0189G, J13F0280G, J13F0281G, J13F0348G, M13F1049G, M13F1050G, C23F1723G, D23F1967G, K13F0402G, K13F0406G, K13F0407G, M13F0969G, M13F0975G, M13F0941G, M13F0948G, J13F0324G, B23F1518G, B23F1538G, M13F1052G, M13F1053G, M13F1066G, M13F1067G, K13F0506G, E23F2030G, B23F1423G, B23F1498G, C23F1750G, C23F1756G, D23F1864G, D23F1879G, D23F1960G, D23F2614G, M13F1130G, M13F1131G, D23F2001G, E23F2069G, M13F0976G, M13F1054G, M13F1136G, M13F1137G, M13F1148G, M13F1149G, A23F1286G, M13F1030G, M13F1031G, B23F1309G, J13F0323G, J13F0271G, L13F0614G, L13F0615G, L13F0663G, M13F0945G, M13F0946G, A23F1294G, B23F1528G, M13F1098G, C23F1786G, A23F1224G, A23F1240G, A23F1269G, B23F1329G, B23F1546G, B23F1547G, D23F1841G, D23F1845G, D23F1848G, D23F1947G, D23F1953G, D23F1954G, D23F1956G, D23F2013G, D23F2016G, D23F2017G, J13F0242G, J43F0481G, L13F0612G, M13F1122G, C23F1585G, L13F0637G, A23F1291G, A23F1293G, C23F1791G, L13F0713G, L13F0714G, L13F0685G, B23F1363G, C23F1789G, C23F1790G, C23F1813G, D23F1926G, D23F1966G, D23F1969G, D23F2000G, D23F2018G, D23F2019G, J13F0026G, J13F0247G, J13F0316G, J13F0317G, J13F0382G, J13F0383G, J13F0384G, K13F0390G, K13F0463G, L13F0753G, L13F0840G, L13F0841G, L13F0842G, M13F1056G, M13F1160G, B23F1372G, D23F1908G, D23F2012G, E23F2031G, L13F0594G, L13F0606G, M13F1110G, M13F1111G, M13F1112G, M13F1113G, M13F1115G, M13F1116G, M13F1117G, M13F1118G, M13F1119G, K13F0465G, K13F0482G, K13F0483G, L13F0596G, L13F0602G, D23F1998G, L13F0772G, M13F1089G, M13F1143G, M13F0928G, F23F2080G, C23F1785G, C23F1795G, D23F1913G, A23F1247G, A23F1248G, A23F1251G, A23F1252G, A23F1253G, B23F1305G, B23F1306G, B23F1314G, B23F1317G, B23F1318G, B23F1320G, B23F1376G, B23F1407G, B23F1408G, B23F1409G, B23F1410G, B23F1457G, B23F1458G, B23F1459G, B23F1460G, B23F1461G, B23F1462G, B23F1463G, B23F1464G, B23F1472G, B23F1474G, B23F1481G, B23F1482G, B23F1491G, B23F1492G, B23F1493G, B23F1494G, C23F1695G, C23F1696G, C23F1697G, C23F1698G… (truncated, 535363 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2019

SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients.

Problem with packaging sealing process which affects sterility.

ALL 50 STATES
Full report

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

Recall #:
83714
Lot/product code:
Lot Numbers 1240 through 1313. Item numbers:   1. 321151-30C;   2. 331151-30C;   3. 321151-31C;   4. 341151-30C;   5. 321151-31A;   6. 341151-31A;   7. 341151-31B;   8. 331151-31B
Recalling firm:
Pajunk GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2019

Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

ALL 50 STATES
Full report

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

Recall #:
83797
Lot/product code:
Product Number / CFN GTIN Lot EUP1506X 00643169559813 217238068 EUP1506X 00643169618695 217291131 EUP1506X 00643169559813 217354645 EUP1506X 00643169979475 217473721 EUP1506X 00643169618695 217473914 EUP1506X 00643169979475 217506615 EUP1506X 00643169979475 217576082 EUP1506X 00643169559813 217638054 EUP1506X 00643169559813 217833021 EUP1506X 00643169979475 217876349 EUP1510X 00643169559820 217225186 EUP1510X 00643169559820 217238070 EUP1510X 00643169618633 217262907 EUP1510X 00643169559820 217371289 EUP1510X 00643169979413 217396792 EUP1510X 00643169979413 217451079 EUP1510X 00643169979413 217473910 EUP1510X 00643169618633 217473911 EUP1510X 00643169979413 217518609 EUP1510X 00643169559820 217602408 EUP1510X 00643169559820 217610624 EUP1510X 00643169618633 217630776 EUP1510X 00643169559820 217656465 EUP1510X 00643169618633 217704793 EUP1510X 00643169979413 217704794 EUP1510X 00643169979413 217803293 EUP1510X 00643169559820 217804976 EUP1510X 00643169979413 217817346 EUP1510X 00643169979413 217939845 EUP1510X 00643169979413 217960062 EUP1512X 00643169979338 217282165 EUP1512X 00643169559837 217282749 EUP1512X 00643169559837 217290758 EUP1512X 00643169618558 217291003 EUP1512X 00643169618558 217396342 EUP1512X 00643169979338 217451080 EUP1512X 00643169559837 217518423 EUP1512X 00643169979338 217584296 EUP1512X 00643169618558 217728406 EUP1512X 00643169559837 217791032 EUP1512X 00643169618558 217803295 EUP1512X 00643169979338 217817347 EUP1512X 00643169559837 217833023 EUP1512X 00643169979338 217876348 EUP1515X 00643169618688 217216700 EUP1515X 00643169979468 217216702 EUP1515X 00643169559844 217225187 EUP1515X 00643169979468 217270937 EUP1515X 00643169979468 217291129 EUP1515X 00643169618688 217291133 EUP1515X 00643169559844 217379139 EUP1515X 00643169979468 217387047 EUP1515X 00643169618688 217396791 EUP1515X 00643169979468 217451566 EUP1515X 00643169618688 217518610 EUP1515X 00643169979468 217518611 EUP1515X 00643169979468 217584297 EUP1515X 00643169979468 217601078 EUP1515X 00643169979468 217630784 EUP1515X 00643169559844 217638060 EUP1515X 00643169559844 217727985 EUP1515X 00643169618688 217728244 EUP1515X 00643169618688 217775695 EUP1515X 00643169979468 217777586 EUP1515X 00643169559844 217786006 EUP1515X 00643169618688 217791230 EUP1515X 00643169979468 217960063 EUP1515X 00643169559844 217961583 EUP1520X 00643169559851 217253539 EUP1520X 00643169618923 217270929 EUP1520X 00643169979703 217270933 EUP1520X 00643169559851 217313635 EUP1520X 00643169979703 217339009 EUP1520X 00643169979703 217370779 EUP1520X 00643169979703 217387049 EUP1520X 00643169979703 217427611 EUP1520X 00643169979703 217444053 EUP1520X 00643169979703 217480193 EUP1520X 00643169559851 217488906 EUP1520X 00643169618923 217506621 EUP1520X 00643169979703 217518608 EUP1520X 00643169618923 217518614 EUP1520X 00643169979703 217577127 EUP1520X 00643169618923 217682939 EUP1520X 00643169618923 217775696 EUP1520X 00643169559851 217791033 EUP1520X 00643169559851 217875827 EUP2006X 00643169559868 217290755 EUP2006X 00643169559868 217325279 EUP2006X 00643169979574 217473906 EUP2006X 00643169979574 217506617 EUP2006X 00643169979574 217601073 EUP2006X 00643169559868 217602407 EUP2006X 00643169979574 217616434 EUP2006X 00643169559868 217646822 EUP2006X 00643169979574 217682942 EUP2006X 00643169618794 217721594 EUP2006X 00643169559868 217791029 EUP2006X 00643169559868 217913568 EUP2010X 00643169559875 217313603 EUP2010X 00643169559875 217371290 EUP2010X 00643169559875 217465238 EUP2010X 00643169618862 217490849 EUP2010X 00643169618862 217506623 EUP2010X 00643169559875 217535671 EUP2010X 00643169979642 217542638 EUP2010X 00643169979642 217557954 EUP2010X 00643169979642 217584304 EUP2010X 00643169979642 217602587 EUP2010X 00643169979642 217616444 EUP2010X 00643169559875 217656461 EUP2010X 00643169979642 217682944 EUP2010X 00643169559875 217728347 EUP2010X 00643169979642 217728410 EUP2010X 00643169559875 217860167 EUP2010X 00643169979642 217891539 EUP2012X 00643169979307 217225194 EUP2012X 00643169979307 217246462 EUP2012X 00643169979307 217270930 EUP2012X 00643169979307 217282164 EUP2012X 00643169979307 217291005 EUP2012X 00643169559882 217325272 EUP2012X 00643169618527 217339010 EUP2012X 00643169979307 217339011 EUP2012X 00643169559882 217339173 EUP2012X 00643169559882 217347821 EUP2012X 00643169559882 217379135 EUP2012X 00643169618527 217379610 EUP2012X 00643169979307 217379612 EUP2012X 00643169979307 217387051 EUP2012X 00643169618527 217387053 EUP2012X 00643169559882 217418683 EUP2012X 00643169559882 217465237 EUP2012X 00643169979307 217451567 EUP2012X 00643169559882 217479184 EUP2012X 00643169559882 217518421 EUP2012X 00643169559882 217535675 EUP2012X 00643169979307 217557965 EUP2012X 00643169979307 217584406 EUP2012X 00643169979307 217602590 EUP2012X 00643169979307 217630783 EUP2012X 00643169559882 217646823 EUP2012X 00643169559882 217668159 EUP2012X 00643169979307 217704795 EUP2012X 00643169559882 217713354 EUP2012X 00643169618527 217713408 EUP201… (truncated, 27676 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular Galway DBA Medtronic Ireland
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2019

Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

ALL 50 STATES
Full report

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

Recall #:
83797
Lot/product code:
Product Number / CFN GTIN Lot SLC1506X 00643169680005 217427355 SLC1510X 00643169680012 217253572 SLC1510X 00643169680012 217298666 SLC1510X 00643169680012 217387126 SLC1510X 00643169680012 217427354 SLC1510X 00643169680012 217487816 SLC1512X 00643169680029 217218112 SLC1512X 00643169680029 217253582 SLC1512X 00643169680029 217387128 SLC1512X 00643169680029 217487818 SLC1512X 00643169680029 217542634 SLC1512X 00643169680029 217859789 SLC1515X 00643169680036 217246455 SLC1515X 00643169680036 217253577 SLC1515X 00643169680036 217306789 SLC1515X 00643169680036 217415822 SLC1515X 00643169680036 217427365 SLC1515X 00643169680036 217823443 SLC1515X 00643169680036 217859165 SLC1515X 00643169680036 217940024 SLC1520X 00643169680043 217253580 SLC1520X 00643169680043 217306787 SLC1520X 00643169680043 217427359 SLC1520X 00643169680043 217542633 SLC1520X 00643169680043 217646425 SLC1520X 00643169680043 217668582 SLC1520X 00643169680043 217799249 SLC1520X 00643169680043 217859164 SLC2006X 00643169680050 217435326 SLC2006X 00643169680050 217913786 SLC2010X 00643169680067 217253573 SLC2010X 00643169680067 217297545 SLC2010X 00643169680067 217387127 SLC2010X 00643169680067 217427356 SLC2010X 00643169680067 217646867 SLC2010X 00643169680067 217668585 SLC2010X 00643169680067 217676631 SLC2010X 00643169680067 217905820 SLC2012X 00643169680074 217253578 SLC2012X 00643169680074 217298670 SLC2012X 00643169680074 217306788 SLC2012X 00643169680074 217415824 SLC2012X 00643169680074 217434925 SLC2012X 00643169680074 217602539 SLC2012X 00643169680074 217668687 SLC2012X 00643169680074 217799250 SLC2012X 00643169680074 217859791 SLC2012X 00643169680074 217940066 SLC2015X 00643169680081 217218115 SLC2015X 00643169680081 217253574 SLC2015X 00643169680081 217271254 SLC2015X 00643169680081 217298669 SLC2015X 00643169680081 217306223 SLC2015X 00643169680081 217404046 SLC2015X 00643169680081 217418812 SLC2015X 00643169680081 217418907 SLC2015X 00643169680081 217427706 SLC2015X 00643169680081 217435327 SLC2015X 00643169680081 217498815 SLC2015X 00643169680081 217615647 SLC2015X 00643169680081 217646871 SLC2015X 00643169680081 217668584 SLC2015X 00643169680081 217713076 SLC2015X 00643169680081 217721607 SLC2015X 00643169680081 217777612 SLC2015X 00643169680081 217799251 SLC2015X 00643169680081 217884509 SLC2015X 00643169680081 217913790 SLC2020X 00643169680098 217218110 SLC2020X 00643169680098 217246457 SLC2020X 00643169680098 217253575 SLC2020X 00643169680098 217271253 SLC2020X 00643169680098 217298667 SLC2020X 00643169680098 217306220 SLC2020X 00643169680098 217387130 SLC2020X 00643169680098 217404047 SLC2020X 00643169680098 217418908 SLC2020X 00643169680098 217487822 SLC2020X 00643169680098 217498821 SLC2020X 00643169680098 217676628 SLC2020X 00643169680098 217713075 SLC2020X 00643169680098 217727927 SLC2020X 00643169680098 217799252 SLC2020X 00643169680098 217850364 SLC2020X 00643169680098 217905822 SLC2025X 00643169680104 217271251 SLC2025X 00643169680104 217542635 SLC2025X 00643169680104 217905821 SLC2030X 00643169680111 217218119 SLC2030X 00643169680111 217427363 SLC2030X 00643169680111 217602538 SLC2030X 00643169680111 217704778 SLC2030X 00643169680111 217777614 SLC22510X 00643169680135 217487815 SLC22510X 00643169680135 217646423 SLC22515X 00643169680159 217427362 SLC22515X 00643169680159 217646422 SLC22520X 00643169680166 217721606 SLC22520X 00643169680166 217913787 SLC22525X 00643169680173 217415820 SLC22525X 00643169680173 218025488 SLC2506X 00643169680180 217823441 SLC2510X 00643169680197 217218122 SLC2510X 00643169680197 217401003 SLC2510X 00643169680197 217427357 SLC2510X 00643169680197 217693881 SLC2510X 00643169680197 217913792 SLC2510X 00643169680197 218034774 SLC2512X 00643169680203 217271257 SLC2512X 00643169680203 217306225 SLC2512X 00643169680203 217415825 SLC2512X 00643169680203 217434924 SLC2512X 00643169680203 217498822 SLC2512X 00643169680203 217606584 SLC2512X 00643169680203 217695006 SLC2512X 00643169680203 217859787 SLC2512X 00643169680203 217913793 SLC2515X 00643169680210 217253581 SLC2515X 00643169680210 217306786 SLC2515X 00643169680210 217401005 SLC2515X 00643169680210 217418813 SLC2515X 00643169680210 217418906 SLC2515X 00643169680210 217427709 SLC2515X 00643169680210 217487819 SLC2515X 00643169680210 217498813 SLC2515X 00643169680210 217542636 SLC2515X 00643169680210 217602540 SLC2515X 00643169680210 217646866 SLC2515X 00643169680210 217693884 SLC2515X 00643169680210 217859788 SLC2515X 00643169680210 217905823 SLC2515X 00643169680210 218045287 SLC2520X 00643169680227 217271256 SLC2520X 00643169680227 217387129 SLC2520X 00643169680227 217404048 SLC2520X 00643169680227 217418909 SLC2520X 00643169680227 217434922 SLC2520X 00643169680227 217487821 SLC2520X 00643169680227 217498819 SLC2520X 00643169680227 217542632 SLC2520X 00643169680227 217646868 SLC2520X 00643169680227 217695009 SLC2520X 00643169680227 217859162 SLC2520X 00643169680227 217913794 SLC2525X 00643169680234 217218108 SLC2525X 00643169680234 21767558… (truncated, 7598 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular Galway DBA Medtronic Ireland
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2019

Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

ALL 50 STATES
Full report

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

Recall #:
83692
Lot/product code:
UDI: (01)00858164002244(10) 5.50.00  (01)00858164002268(10) 5.51.00
Recalling firm:
Elekta Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2019

Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

ALL 50 STATES
Full report

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

Recall #:
83692
Lot/product code:
UDI (01)00858164002190(10) 5.40.00
Recalling firm:
Elekta Inc
View official FDA record (opens in a new tab)