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Recalls affecting District of Columbia

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

16,214 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 August 15, 2018

da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.

ALL 50 STATES
Full report

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

Recall #:
80696
Lot/product code:
Model Number 47179-14 Device Listing D215864 UDI Number 00886874112298 Lot Numbers: S11160307 N11171009 N10171010 N10171012 N10180219 N10180214 N10180212 N10180220 N10180221 N10171017 N10180213 N10180215 T10180212 N11180212 T10180208 N10171002 N10170921 N10171023 N10171018 N10170819 N10170818 N10170911 N10170807 N10170808 N10170914 N10171016 N10170718 N10171019 N10171005 N10171009 N10171004 N10171003 N11170911 N10170927 N10170926 N10170815 N11170922 N11170912 N10170809 N10170814 N10170925 N10170922 N10170728 N10170713 N10170912 N10170614 N10170906 N10170824 N10170703 N10170816 N10170811 T10170720 N10170727 N10170724 N10170712 N10170803 N10170721 N10170802 N10170602 N10170720 N10170620 N10170719 N10170801 N10170714 N10170619 N10170711 S10170525 N10170626 N10170613 N11170513 N10170706 N11170223 N10170531 N10170628 N10170612 N10170629 S10170705 S10170523 N10170616 N10170605 N10170615 N10170307 N10170622 N10170518 N10170609 N10170607 N10170504 N10170606 N11161213 N10160831 N10170317 N10170418 N10170601 N10170526 N10170405 N10170511 N10170524 N10170522 N10170508 N10170519 N10170513 N10170515 N11170306 N10170509 N10170516 N10170428 N12170223 S10170501 S10170223 N11170429 N10170427 N11170428 N10170406 N10170429 N10170426 N10170420 N10170424 N10170419 N10170324 N10170328 N10170417 N11170224 S10170417 N10170411 N10170224 N10170412 N10170410 N10170303 N10170404 N11170120 N11170405 N10170403 S10170405 N10170331 N10170302 N10170314 N10170321 N10170131 N10170306 N11170327 N10170309 S10161213 N10170327 N10170117 N10170323 N10170301 N10170313 N10170316 N10170315 N11161117 S10170317 N10170310 N10170227 N10170216 N11161215 N12170306 N10170222 N11170216 S10161130 N11170301 N10170228 S10170224 N10170223 N10170127 N10170217 N10170214 N10170209 N10170207 N11170214 N11170117 N10170215 N11170104 N10170210 N10170208 S10170125 N10170110 N10170112 N10170203 N10170130 N10170123 N11170123 S10161207 N10170120 N11170112 S10170120 N10170125 S10161208 S10170201 N11170125 N10170104 S10170126 N10170119 N10161205 N10161216 N10161228 N11170110 N11161216 N10161117 N11161130 N11170105 N10161202 N10161026 N10170105 N10161004 N11161221 N10161011 N10161229 N11161212 N11161209 N10161221 N10161215 N11161014 N10161214 S10161117 N10161213 N10161212 N10161124 N10160921 N10161209 N10161130 S10160922 N11161122 N10160809 N10161107 N10161122 N11161114 N11161111 N11161107 S10161116 N10160912 N10161111 N10160908 N10161103 S10160901 N10161114 N10161018 N10161104 N10161110 N11161104 N10160802 N10161102 N10160727 S10161108 S10160428 N11161028 N10161006 N10161025 N10161028 N10161024 N10160919 S10161024 N10161021 N11160905 N10161014 N11161018 S10161020 N10160915 S10161019 S10161013 N10160822 S10160307 S10161012 N10160824 N11161006 N11160706 N10160719 N11160912 S10161003 N10160914 N11160816 N10160926 N10160816 N10160525 N11160926 S10160614 N10160920 S10160927 S10160527 N10160811 S10160916 N10160905 N10160825 N11160831 S10160811 N11160725 S10160728 S10160718 N10160823 N11160825 S10160712 S10160705 N11160427 N10160728 S10160817 N11160808 S10160815 N10160808 N10160801 N11160601 N10160725 N10160803 N10160527 S10160803 N10160607 N10160714 N10160720 S10160713 S10160506 S10160629 N10160713 N11160720 N11160714 N11160628 N10160708 N10160405 N10160706 N10160628 N10160701 S10160324 N10160624 N11160624 S10160321 N10160617 N10160526 N10160615 N10160620 N10160613 N10160610 N10160608 S10160415 N10160506 N10160606 N10160519 N10160601 N10160517 N10160524 S10160513 N10160520 N10160516 N10160418 N10160513 N10160512 N10160511 N10160505 N12160316 N10160504 N10160428 N10160427 N10160316 N11160316 S10160422 N10160426 N10160419 N10160331 N10160414 N10160412 N10160329 S10160406 S10160318 N10160404 S10160401 S10160302 S10160325 N10160301 S10160229 S10160227 S10160219 S12160114 S11160114 S10160114
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled August 15, 2018

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

ALL 50 STATES
Full report

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

Recall #:
D-0081-2019
Lot/product code:
Lot #: MON17384, Exp 12/19
Recalling firm:
Hetero Labs Limited Unit V
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 15, 2018

da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.

ALL 50 STATES
Full report

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

Recall #:
80696
Lot/product code:
Model Number 420179-16 Device Listing D088920 UDI Number 00886874111505 Lot Numbers: N10170912 N10170928 N10170419 N10170927 N10170919 N10171009 N10170731 N10170529 N11170912 N11170909 N10170828 N10170922 N10161014 N10170522 N10170808 N10170904 N10171010 N10170920 N10170921 N10170804 N10170905 N11170905 N11170725 N10170918 N10170703 N10170911 N11170920 N10171004 N11170227 N10170908 N10170821 N10170801 N10170725 N10170822 N10170524 N10161019 N11160701 N10170705 N11170703 N11170705 N11170522 N11170605 N10170605 N10170516 N10170602 N11170419 N10170308 N11170308 N10170508 N10170303 N12170308 N10170418 N12170310 N10170412 N11170412 N12170412 N10170407 N10170502 N11170207 N10170321 N14170310 N11170202 N11170119 N11170303 N10161129 N13170310 N11170407 N11170214 N11170310 N10170310 N12170214 N10170213 N10170130 N10170202 N11161115 N10170207 N12170123 N10161018 N10170214 N11161014 N10161222 N11170213 N10170119 N11170123 N11161129 N11161212 N10170123 N10161208 N11160926 N11161021 N11170105 N12160707 N10170105 N10161212 N10161115 N11161025 N11161118 N10161118 N10161021 N11161122 N10161026 N10161122 N10161031 N10160701 N11161026 N10161025 N11160608 N10160708 N10160824 N11160629 N11161019 N10160926 N12160824 N11160913 N10160808 N11160808 N10160707 N10160913 N11160622 N13160824 N11160824 N10160608 N10160305 N10160524 N14160824 N11160705 N10160705 N10160714 N10160603 N11160511 N11160708 N10160217 N10160420 N10160429 N10160629 N11160425 N11150929 N10160511 N10160622 N11160429 N10160212 N10160322 N12150929 N10160614 N11160614 N11160603 N10160510 N11160309 N10160523 N11160129 N10160323 N10160328 N10150929 N10160202 N10160425 N10160413 N11160413 N10160406 N10160408 N10160316 N10160401 N10160309 N10160121 N10160129 N10160226 N10160229 N11160301 N10160227 N10160211 N11160202
Recalling firm:
Intuitive Surgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 15, 2018

TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.

The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

ALL 50 STATES
Full report

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

Recall #:
83984
Lot/product code:
Lot # 110631.
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1144-2018
Lot/product code:
Batch: BBX9D004, BBX9E001, BBX9D001, BBX9D002, BBX9D003
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1137-2018
Lot/product code:
Batch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1141-2018
Lot/product code:
Batch: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1135-2018
Lot/product code:
Batch: BV47C005, BV47C006, BV47D001, BV47C003, BV47C004
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1134-2018
Lot/product code:
Batch: BV46C007, BV46C008, BV46C009, BV46C010, BV46C011, BV46C012, BV46C003, BV46C006
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1145-2018
Lot/product code:
Batch: BBY4D004, BBY4E001, BBY4D001, BBY4D002, BBY4D003
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1136-2018
Lot/product code:
Batch: BV48D001, BV48D002
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1138-2018
Lot/product code:
Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1142-2018
Lot/product code:
Batch: BBY1E001, BBY1E003, BBY1C002, BBY1E002, BBY1D001
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1140-2018
Lot/product code:
Batch: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, BV53C005
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1139-2018
Lot/product code:
Batch: BV65D002, BV65C002, BV65C003, BV65C004, BV65D001
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

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-1143-2018
Lot/product code:
Batch: BBY2E001, BBY2D001, BBY2D002
Recalling firm:
Torrent Pharma Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2018

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

ALL 50 STATES
Full report

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

Recall #:
80996
Lot/product code:
Serial Numbers: 5214432, 5214445
Recalling firm:
Exactech, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2018

Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.

The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.

ALL 50 STATES
Full report

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

Recall #:
81106
Lot/product code:
UDI Number 0888867223349; Material Number AR-400UBH;   Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435
Recalling firm:
Arthrex, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2018

Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2018

Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2018

Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2018

Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2018

Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2018

Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2018

GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation, -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

ALL 50 STATES
Full report

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

Recall #:
81075
Lot/product code:
Serial numbers: No UDI: SJA15150092HA SJA15150100HA SJA15150124HA SJA15150125HA SJA15150126HA SJA15150127HA SJA15150128HA SJA15150139HA SJA15170033HA SJA15170079HA SJA15170081HA SJA15170085HA SJA15170086HA SJA15170087HA SJA15170088HA SJA15170089HA SJA15170090HA SJA15170091HA SNE16060190HA SNE16110218HA SJA14127613HA SJA14127614HA SJA15262026HA SJA15262173HA SJA15272036HA SJA15282008HA SJA15282009HA SJA15282010HA SJA15282014HA SJA15282015HA SJA15282016HA SJA15282017HA SJA15282019HA SJA15282022HA SJA15282024HA SJA15282043HA SJA15282044HA SJA15282048HA SJA15282051HA SJA15282054HA SJA15282055HA SJA15282059HA SJA15282060HA SJA15282063HA SJA15282065HA SJA15282118HA SJA15282122HA SJA15282125HA SJA15282128HA SJA15282129HA SJA15282131HA SJA15282134HA SJA15282135HA SJA15282141HA SJA15282149HA SJA15382048HA SJA14437335HA SJA14437337HA SJA14127619HA SJA14127621HA SJA14127622HA SJA14127623HA SJA14127624HA SJA14127626HA SJA14392398HA SJA14392402HA SJA14192489HR SJA14302513HR SJA15401023HR SJA15170060HA SJA15170127HA SJA15170128HA SJA15170129HA SJA15170130HA SJA15170137HA SJA15292063HA SJA14473730HA SNE15480016HA SNE15480017HA SNE15480019HA SNE15511032HA SJA15342151HA SJA15342152HA SJA15252097HA SJA15252142HA SJA15252143HA SJA15252144HA SJA15252149HA SJA15252150HA SJA15252151HA SJA15262060HA SJA15262061HA SJA15262062HA SJA15262063HA SJA15262064HA SJA15262068HA SJA15262069HA SJA15262070HA SJA15452019HA SNE15431001HA SNE16010064HA SNE16010070HA SNE16010071HA SNE16010078HA SNE16010079HA SNE16010080HA SJA15262004HA SJA15262005HA SJA14403421HA SJA15101137HA SNE16110060HA SNE16110063HA SNE16110065HA SNE16110066HA SJA15262006HA SNE16080111HA SNE16080112HA SNE16080113HA SNE16080114HA SNE16080115HA SNE16080116HA SNE16080117HA SNE16080118HA SNE16080119HA SNE16080121HA SNE16050129HA SNE16050131HA SNE16120029HR SNE16120040HR SNE15520017HA SNE15520018HA SNE15520019HA SNE15520020HA SNE15520022HA SNE15531045HA SNE15531046HA SNE16010075HA SNE16010076HA SNE16010077HA SNE15520036HA SNE15520079HA SNE15520080HA SNE16080202HA SNE16080203HA SNE16080204HA SNE16080206HA SNE16080207HA SNE16090021HA SNE16090022HA SNE16090024HA SNE16090025HA SNE16090027HA SNE16090029HA SNE16090031HA SNE16090032HA SNE16130019HA SNE16130020HA SNE16130023HA SNE16130024HA SJA14138552HA SJA14138553HA SJA14138555HA SJA14138558HA SJA15120117HA SJA15120146HA SJA15120147HA SJA15120148HA SJA15120149HA SJA15120150HA SJA15120151HA SJA15120152HA SJA15120154HA SJA15120155HA SJA15120156HA SJA15120157HA SJA15120161HA SJA15120164HA SJA15120165HA SJA15120166HA SJA15120168HA SJA15140138HA SJA15140139HA SJA15140140HA SJA15140141HA SJA15140145HA SJA15140146HA SJA15140147HA SJA15140148HA SJA15101204HA SJA15101207HA SJA15101221HA SJA15101224HA SJA15101235HA SJA15101240HA SJA15101243HA SJA15121009HA SJA15044565HA SJA15044566HA SJA15044567HA SJA15044569HA SJA15044571HA SJA15101292HA SJA15101293HA SJA15112630HA SJA15112631HA SJA15112632HA SJA15112633HA SJA15112635HA SJA15112636HA SJA15112637HA SJA15112638HA SJA15112639HA SJA15112640HA SJA15170076HA SJA15066575HA SJA15066586HA SJA15066599HA SJA15066600HA SNE16121015HA SJA13507992HR SJA14415427HR SNE16191082HR SJA15222023HA SNE16090200HA SJA14358266HA SJA14358267HA SJA14379900HA SJA14379901HA SJA14472381HA SJA15302035HA SJA15302041HA SJA14403455HA SJA14403456HA SJA15031768HA SJA15031818HA SJA15031819HA SJA15033243HA SJA15033244HA SJA15033245HA SJA15066593HA SJA15090664HA SJA15090665HA SJA15090675HA SNE15450027HA SNE15450028HA SNE15450029HA SJA14460951HA SJA14460973HA SNE17251032HA SJA15382323HA SJA14414517HA SJA15020681HA SJA15322125HA SJA15322131HA SJA15332114HA SJA15332124HA SJA15332138HA SJA15332139HA SJA15332141HA SJA15332142HA SJA15332143HA SJA15332144HA SJA15332145HA SJA15332149HA SJA15332150HA SJA15332151HA SJA14291680HA SJA15171001HA SJA15171002HA SJA15171003HA SJA15171005HA SJA15171006HA SJA15291004HA SNE15511001HA SNE15511004HA SNE15511008HA SNE15511014HA SNE16021001HA SNE16021002HA SJA13507985HA SJA13508793HA SJA13508794HA SJA13508795HA SJA13019537HA SJA13508792HA SJA13508796HA SJA13508797HA SJA14314410HA SNE16110126HA SNE15490001HA SNE15490034HA SNE15490070HA SNE15520077HA SNE15520078HA SNE15520088HA SNE15520089HA SNE15520090HA SJA14459942HA SJA14507676HA SJA14507679HA SJA14507680HA SJA14507691HA SJA14507692HA SJA14507703HA SJA14507704HA SJA14519037HA SJA14519039HA SJA14519041HA SJA14519042HA SJA14519043HA SJA14519045HA SJA14519046HA SJA14519048HA SNE15511016HA SNE15531064HA SJA13519474HR SNE16181001HR SNE16181014HR SNE16181029HR SNE16181033HR SNE16181035HR SNE16181041HR SNE16181042HR SNE16181047HR SNE16181048HR SNE16181054HR SNE16181056HR SNE16181059HR SNE16181061HR SNE16181062HR SNE16181070HR SNE16191003HR SNE16191008HR SNE16191010HR SNE16191015HR SNE16191016HR SNE16191017HR SNE16191028HR SNE16191029HR SNE16191055HR SNE16191068HR SNE16191071HR SNE16191073HR SNE16191076HR SNE16191078HR SJA14381877HA SJA14381881HA SJA14381885HA SJA14392419HA SJA14392420HA SJA14392421HA SJA14392422HA SJA14392423HA SJA14392424HA SJA14392425HA SJA143… (truncated, 2210545 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare Finland Oy
View official FDA record (opens in a new tab)