BIGNOPE
Ko-fi

Recalls affecting South Dakota

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

16,341 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 Men — dietary 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 Alive — Moringa 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. Braun — 0.9% 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 Value — Organic 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

Lipofit — Lipofit 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

Kofinas — Garlic 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 Temptations — Chocolatey 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 Sprouts — Robust 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

Martina — Mangoes

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)
NewestOldest
High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled November 14, 2019

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

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

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

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

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

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

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

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

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

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

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

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

Recall #:
84499
Lot/product code:
The products involved are DeWALT laser distance measurers, model numbers DWO 165, DWO 1 65S, DW0330S and Stanley Fat Max FMHT77506 TLM 165. These products were produced for DeWALT and Stanley by a contract manufacturer..
Recalling firm:
STANLEY BLACK & DECKER INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

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

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

ALL 50 STATES
▸Full report

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

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

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

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

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84430
Lot/product code:
All Serial Numbers ( excluding devices with black retainer rings)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2019

LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

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

ALL 50 STATES
▸Full report

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

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

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

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

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-0612-2020
Lot/product code:
AR171764A 11/2019 AR171875A 11/2019 AR171876A 11/2019 AR171981A 11/2019 AR180020C 1/2020 AR180206A 1/2020 AR180207A 1/2020 AR180208A 1/2020 AR180438A 2/2020 AR180439A 2/2020 AR180481A 3/2020 AR180482A 3/2020 AR180483A 3/2020 AR181690A 10/2020 AR181691A 10/2020 AR181806A 11/2020 AR190058A 12/2020 AR190059A 12/2020 AR190183A 1/2021 AR190184A 1/2021 AR171984A 12/2019 AR180020B 1/2020 AR180675A 4/2020 AR180868B 5/2020 AR181807A 11/2020 AR190366B 2/2021 AR171986A 12/2019 AR171987A 12/2019 AR180255A 1/2020 AR180441A 2/2020 AR180442A 2/2020 AR180559A 3/2020 AR180560A 3/2020 AR180594A 3/2020 AR180595A 3/2020 AR180829A 4/2020 AR180831A 5/2020 AR180832A 5/2020 AR180868A 5/2020 AR181807C 11/2020 AR190085A 12/2020 AR190086A 12/2020 AR190087A 12/2020 AR190124A 1/2021 AR190542B 3/2021 AR190609A 3/2021 AR190610A 3/2021 AR171875B 11/2019 AR180483B 3/2020 AR181807B 11/2020 AR190008B 12/2020 AR171763A 11/2019 AR171764B 11/2019 AR171874A 11/2019 AR171875C 11/2019 AR171877B 11/2019 AR171878B 11/2019 AR171982A 11/2019 AR171983A 12/2019 AR171985A 12/2019 AR180016A 12/2019 AR180017A 12/2019 AR180018A 12/2019 AR180019A 12/2019 AR180020A 1/2020 AR180208B 1/2020 AR180256A 1/2020 AR180291A 1/2020 AR180292A 1/2020 AR180293A 1/2020 AR180294A 2/2020 AR180295A 2/2020 AR180364A 2/2020 AR180365A 2/2020 AR180366A 2/2020 AR180367A 2/2020 AR180368A 2/2020 AR180440B 2/2020 AR180484A 3/2020 AR180485A 3/2020 AR180556A 3/2020 AR180557A 3/2020 AR180558A 3/2020 AR180596A 3/2020 AR180597A 3/2020 AR180598A 3/2020 AR180599A 3/2020 AR180675B 4/2020 AR180676A 4/2020 AR180677A 4/2020 AR180678A 4/2020 AR180679A 4/2020 AR180801A 4/2020 AR180802A 4/2020 AR180803A 4/2020 AR180869A 5/2020 AR180870A 5/2020 AR180871A 5/2020 AR180872A 5/2020 AR180994A 5/2020 AR180995A 5/2020 AR180996A 5/2020 AR180997A 6/2020 AR180998A 6/2020 AR181158A 7/2020 AR181159A 7/2020 AR181160A 7/2020 AR181161A 7/2020 AR181692A 10/2020 AR181693A 10/2020 AR181694A 10/2020 AR181709A 10/2020 AR181710A 11/2020 AR181711A 11/2020 AR181808A 11/2020 AR181809A 11/2020 AR190004A 12/2020 AR190005A 12/2020 AR190006A 12/2020 AR190007A 12/2020 AR190008A 12/2020 AR190088A 12/2020 AR190089A 12/2020 AR190090A 12/2020 AR190121A 12/2020 AR190122A 12/2020 AR190123A 12/2020 AR190125B 1/2021 AR190181A 1/2021 AR190182A 1/2021 AR190364A 2/2021 AR190365A 2/2021 AR190366A 2/2021 AR190509A 3/2021 AR190510A 3/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

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

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-0614-2020
Lot/product code:
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

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

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-0613-2020
Lot/product code:
AR172033B 11/2019 AR180024A 12/2019 AR180025A 12/2019 AR180118A 12/2019 AR180119A 12/2019 AR180519A 3/2020 AR180615A 3/2020 AR181795A 11/2020 AR181921B 12/2020 AR190705A 4/2021 AR172029A 11/2019 AR172030A 11/2019 AR180021A 12/2019 AR180022A 12/2019 AR180023A 12/2019 AR180123A 12/2019 AR180144A 1/2020 AR180145A 1/2020 AR180146A 1/2020 AR180147A 1/2020 AR180402A 2/2020 AR180465A 2/2020 AR180466A 2/2020 AR180467A 2/2020 AR180468A 2/2020 AR180613A 3/2020 AR181156A 7/2020 AR181157A 7/2020 AR190418B 2/2021 AR171800A 11/2019 AR171801A 11/2019 AR171802A 11/2019 AR171803A 11/2019 AR171804A 11/2019 AR171931A 11/2019 AR171932A 11/2019 AR171933A 11/2019 AR171934A 11/2019 AR171935A 11/2019 AR171936A 11/2019 AR171937A 11/2019 AR172026A 11/2019 AR172027A 11/2019 AR172028A 11/2019 AR172031A 11/2019 AR172032A 11/2019 AR172033A 11/2019 AR172034A 11/2019 AR172035A 11/2019 AR180030A 12/2019 AR180031A 12/2019 AR180032A 12/2019 AR180033A 12/2019 AR180034A 12/2019 AR180113A 12/2019 AR180114A 12/2019 AR180115A 12/2019 AR180117A 12/2019 AR180120A 12/2019 AR180121A 12/2019 AR180122A 12/2019 AR180148A 1/2020 AR180198A 1/2020 AR180199A 1/2020 AR180200A 1/2020 AR180201A 1/2020 AR180202A 1/2020 AR180257A 1/2020 AR180258A 1/2020 AR180335A 2/2020 AR180336A 2/2020 AR180337A 2/2020 AR180338A 2/2020 AR180339A 2/2020 AR180374A 2/2020 AR180375A 2/2020 AR180376B 2/2020 AR180403A 2/2020 AR180404A 2/2020 AR180405A 2/2020 AR180406A 2/2020 AR180424A 2/2020 AR180486A 3/2020 AR180487A 3/2020 AR180488A 3/2020 AR180515A 3/2020 AR180516A 3/2020 AR180517A 3/2020 AR180518A 3/2020 AR180638A 3/2020 AR180640A 4/2020 AR180641A 4/2020 AR181920A 12/2020 AR181921A 12/2020 AR190414B 2/2021 AR190415A 2/2021 AR190416A 2/2021 AR190417A 2/2021 AR190418A 2/2021 AR190543A 3/2021 AR190544A 3/2021 AR190545A 3/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

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

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

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

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

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

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-0616-2020
Lot/product code:
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2019

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

ALL 50 STATES
▸Full report

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

Recall #:
85466
Lot/product code:
all affected systems
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2019

Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

ALL 50 STATES
▸Full report

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

Recall #:
85466
Lot/product code:
all affected systems
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2019

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

ALL 50 STATES
▸Full report

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

Recall #:
85466
Lot/product code:
all affected systems
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2019

Lunar iDXA bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

ALL 50 STATES
▸Full report

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

Recall #:
85466
Lot/product code:
all affected systems
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2019

ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.

Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

ALL 50 STATES
▸Full report

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

Recall #:
84511
Lot/product code:
PRODUCT CODE UDI 7N8300 85412091839 7N8301 85412475387 7N8301K 85412499635 7N8310 85412476728 7N8330K 85412613499 7N8332K 85412599625 7N8334K 85412613482 7N8370K 85412613505 7N8371 85412091822 7N8375K 85412613475 7N8376K 85412599601 7N8377 85412091808 7N8378 85412091792 7N8390 85412475417 7N8391 85412475400 7N8399 85412091785 7N8399K 85412478227   All Lots
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2019

Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.

Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

ALL 50 STATES
▸Full report

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

Recall #:
84511
Lot/product code:
Product Codes: 2C8519, UDI 00085412048994; 2C8537, UDI 00085412048970; and 2C8541, UDI 00085412071107 All Lots
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60

CGMP Deviations: Presence of NDMA impurity detected in 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-0639-2020
Lot/product code:
7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01

CGMP Deviations: Presence of NDMA impurity detected in 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-0640-2020
Lot/product code:
7701033A 7701826A 7702344A 7702345A 7702489A 7702706A 7702707A 7702708A 7702858A 7702859A 7702860A 7702928A 7702929A 7703196A 7703634A 7704492A 7704493A 7705159A 19190289 19190342 19190372
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20

CGMP Deviations: Presence of NDMA impurity detected in 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-0643-2020
Lot/product code:
7701069A 7701070A 7701084A 7701085A 7701087A 7701094A 7701095A 7701140A 7701141A 7701142A 7701157A 7701162A 7701182A 7701217A 7701218A 7701219A 7701236A 7701237A 7701220A 7701456A 7701470A 7701520A 7701671A 7701696A 7701697A 7701698A 7701797A 7701928A 7701929A 7701942A 7701943A 7702065A 7702066A 7702067A 7702095A 7702096A 7702097A 7702098A 7702188A 7702189A 7702190A 7702196A 7702197A 7702198A 7702199A 7702348A 7702338A 7702347A 7702349A 7702350A 7702391A 7702392A 7702546A 7702547A 7702548A 7702616A 7702617A 7702618A 7702619A 7702620A 7702763A 7702764A 7702851A 7702852A 7702853A 7702854A 7702855A 7702868A 7702869A 7702870A 7702871A 7702920A 7703054A 7703055A 7703056A 7703057A 7703058A 7703206A 7703208A 7703454A 7703455A 7703456A 7703486A 7703487A 7703488A 7703489A 7703490A 7703945A 7703946A 7703947A 7704111A 7704112A 7704113A 7704234A 7704235A 7704236A 7704237A 7704285A 7704286A 7704287A 7704288A 7704370A 7704371A 7704428A 7704429A 7704430A 7704431A 7704814A 7704838A 7704839A 7704840A 7704935A 7704936A 7704992A 7704996A 7704997A 7704998A 7704999A 7705037A 7705298A 7705299A 7705300A 7705301A 7705302A 7705303A 7705546A 7705584A 7705544A 7705545A 7705572A 7705585A 19190456 19190472 19190490 19191934 19191942 19191959 19192504
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)