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Recalls affecting South Carolina

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

16,870 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2020

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

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

Recall #:
85912
Lot/product code:
Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2020

Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

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

Recall #:
85912
Lot/product code:
Model Numbers: 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82. Software Version V6.0
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
▸Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
▸Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
▸Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
▸Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

There are reports of the suction catheter coming apart from the device assembly during use.

ALL 50 STATES
▸Full report

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

Recall #:
85983
Lot/product code:
Model: DYNCPTP14, Lot #6919020016:
Recalling firm:
Medline Industries Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

There are reports of the suction catheter coming apart from the device assembly during use.

ALL 50 STATES
▸Full report

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

Recall #:
85983
Lot/product code:
Model: DYNCPTP14T, Lot #6918100021:
Recalling firm:
Medline Industries Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2020

Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.

ALL 50 STATES
▸Full report

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

Recall #:
85919
Lot/product code:
All serial numbers
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 3, 2020

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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

Recall #:
D-1386-2020
Lot/product code:
a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21
Recalling firm:
Granules Pharmaceuticals Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 5, 2020

DYNEX Agility, Agility Analyzer, Model No. 67000

Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.

ALL 50 STATES
▸Full report

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

Recall #:
90099
Lot/product code:
UDI-DI: 05060456180058 Software version v1.4.3 Serial numbers: 1GXA0021 1GXA0022 1GXA0023 1GXA0024 1GXA0025 1GXA0026 1GXA0027 1GXA0028 1GXA0029 1GXA0030 1GXA0031 1GXA0032 1GXA0033 1GXA0034 1GXA0035 1GXA0036 1GXA0037 1GXA0038 1GXA0039 1GXA0040 1GXA0041 1GXA0042 1GXA0043 1GXA0044 1GXA0045 1GXA0046 1GXA0047 1GXA0048 1GXA0049 1GXA0050 1GXA0051 1GXA0052 1GXA0053 1GXA0054 1GXA0055 1GXA0056 1GXA0057 1GXA0058 1GXA0059 1GXA0060 1GXA0061 1GXA0062 1GXA0063 1GXA0064 1GXA0065 1GXA0066 1GXA0067 1GXA0068 1GXA0069 1GXA0070 1GXA0071 1GXA0072 1GXA0073 1GXA0074 1GXA0075 1GXA0076 1GXA0077 1GXA0078 1GXA0079 1GXA0080 1GXA0081 1GXA0082 1GXA0083 1GXA0084 1GXA0085 1GXA0086 1GXA0087 1GXA0088 1GXA0089 1GXA0090 1GXA0091 1GXA0092 1GXA0093 1GXA0094 1GXA0095 1GXA0096 1GXA0097 1GXA0098 1GXA0099 1GXA0100 1GXA0101 1GXA0102 1GXA0103 1GXA0104 1GXA0105 1GXA0106 1GXA0107 1GXA0108 1GXA0109 1GXA0110 1GXA0111 1GXA0112 1GXA0113 1GXA0114 1GXA0115 1GXA0116 1GXA0117 1GXA0118 1GXA0119 1GXA0120 1GXA0121 1GXA0122 1GXA0123 1GXA0124 1GXA0125 1GXA0126 1GXA0127 1GXA0128 1GXA0129 1GXA0130 1GXA0131 1GXA0132 1GXA0133 1GXA0134 1GXA0135 1GXA0136 1GXA0137 1GXA0138 1GXA0139 1GXA0140 1GXA0141 1GXA0142 1GXA0143 1GXA0144 1GXA0145 1GXA0146 1GXA0147 1GXA0148 1GXA0149 1GXA0150 1GXA0151 1GXA0152 1GXA0153 1GXA0154 1GXA0155 1GXA0156 1GXA0157 1GXA0158 1GXA0159 1GXA0160 1GXA0161 1GXA0162 1GXA0163 1GXA0164 1GXA0165 1GXA0166 1GXA0167 1GXA0168 1GXA0169 1GXA0170 1GXA0171 1GXA0172 1GXA0173 1GXA0174 1GXA0175 1GXA0176 1GXA0177 1GXA0178 1GXA0179 1GXA0180 1GXA0181 1GXA0182 1GXA0183 1GXA0184 1GXA0185 1GXA0186 1GXA0187 1GXA0188 1GXA0189 1GXA0190 1GXA0191 1GXA0192 1GXA0193 1GXA0194 1GXA0195 1GXA0196 1GXA0197 1GXA0198 1GXA0199 1GXA0200 1GXA0201 1GXA0202 1GXA0203 1GXA0204 1GXA0205 1GXA0206 1GXA0207 1GXA0208 1GXA0209 1GXA0210 1GXA0211 1GXA0212 1GXA0213 1GXA0214 1GXA0215 1GXA0216 1GXA0217 1GXA0218 1GXAB001 1GXAB002 1GXAB003 1GXAB004 1GXAB005 1GXAB006 1GXAB007 1GXAB008 1GXAB009 1GXAB010 1GXAB011 1GXAB012 1GXAB013 1GXAB014 1GXAB015 1GXAB016 1GXAB017 1GXAB018 1GXAB019 1GXAB020
Recalling firm:
Dynex Technologies, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053

Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device

ALL 50 STATES
▸Full report

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

Recall #:
86027
Lot/product code:
Lot Number: 108332-A  UDI: (01)0084113212400(10)108332A
Recalling firm:
OrthoPediatrics Corp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00562402 Inner Package UPN #: M00562400 GTIN: 08714729501640 Lot #s: 25111007, 25133479, 25142120, 25299896, 25351474, 25357539, 25402321 Expiration Dates: 28-Jan-23 through 24-Mar- 23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00562401 Inner Package UPN #: M00562400 GTIN: 08714729019411 Lot #s: 25321152, 25338467, 25426642 Expiration Dates: 6-Mar-23 through 31-Mar-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00562341 Inner Package UPN #: M00562340 GTIN: 08714729019350 Lot #s: 25077093, 25164173, 25185062, 25187234, 25226123, 25255681, 25336754, 25403003, 25508379, 25524901 Expiration Dates: 20-Jan-23 through 14-May-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00562321 Inner Package UPN #: M00562320 GTIN: 08714729019336 Lot #s: 25158564, 25245733, 25245735, 25330549, 25403001, 25439073, 25513671 Expiration Dates: 4-Feb-23 through 14-May-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00562371 Inner Package UPN #: M00562370 GTIN: 08714729019381 Lot #s: 25143083, 25508441 Expiration Dates: 2-Feb-23 through 14-May-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00561291 Inner Package UPN #: M00561290 GTIN: 08714729645801 Lot #s: 25170944, 25219286, 25368742, 25412118, 25508371 Expiration Dates: 5-Feb-23 through 13-May-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 6, 2020

Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal friction during extension and retraction of the loop from the sheath. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.

ALL 50 STATES
▸Full report

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

Recall #:
86004
Lot/product code:
Outer Package UPN #: M00561311 Inner Package UPN #: M00561310 GTIN: 08714729019251 Lot #s: 25199777, 25330546, 25374640, 25424470,  Expiration Dates: 11-Feb-23 through 31-Mar-23
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 8, 2020

System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147

During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.

CACTIDLAMTNVOHSCWIWV
▸Full report

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

Recall #:
86077
Lot/product code:
The following serial numbers are affected: U4D1992027, U4D19X2029, U4D19Y2030, U4D19Y2031, U4D19Y2033, U4E2012035, U4E2012036, U4E2022037, U4D19Y2032, U4E19Z2034 and U4E2032041.
Recalling firm:
Canon Medical System, USA, INC.
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UnclassifiedRisk not yet known
Medical deviceRecalled July 13, 2020

Medtronic SynchroMed, Model A10

The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

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

Recall #:
93401
Lot/product code:
GTIN 00643169771031, All serial numbers with software version 1.1.300.
Recalling firm:
Medtronic Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2020

Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection.

The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval.

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

Recall #:
86607
Lot/product code:
Lots  060620MB1  061420MB2  062120MB1  062220MB2  060620MB2  052220MB1  051820D01  060120D01  061520MA1  062220D02  061720MB1  052720D02  061920E01  052120E01
Recalling firm:
Thomas Scientific
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UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

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

Recall #:
86115
Lot/product code:
1. FR4A-RCV-A0 US, Serial Numbers: 210426-88, 210426-89, 210426-90, 210426-91, 210426-92, 210426-93; 2. FR4A-RCV-A0 EU, Serial Numbers: 210425-19, 210425-22, 210425-23, 210425-6, 210425-63, 210425-64, 210425-7.
Recalling firm:
Stimwave Technologies Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

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

Recall #:
86115
Lot/product code:
FR4A-SPR-BO-US, Serial Numbers: 210431-88, 210431-89, 210431-90, 210431-91, 210431-92, 210431-93;
Recalling firm:
Stimwave Technologies Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

The product contains a non-functional component not referenced in product labeling.

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▸Full report

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

Recall #:
86115
Lot/product code:
Serial Numbers: 211662-1, 211662-10, 211662-11, 211662-12, 211662-13, 211662-14, 211662-15, 211662-16, 211662-17, 211662-18, 211662-19, 211662-2, 211662-20, 211662-21, 211662-22, 211662-23, 211662-24, 211662-25, 211662-26, 211662-27, 211662-28, 211662-29, 211662-3, 211662-30, 211662-31, 211662-32, 211662-33, 211662-34, 211662-35, 211662-36, 211662-37, 211662-38, 211662-39, 211662-4, 211662-40, 211662-41, 211662-42, 211662-43, 211662-44, 211662-45, 211662-46, 211662-47, 211662-48, 211662-49, 211662-5, 211662-50, 211662-51, 211662-52, 211662-53, 211662-54, 211662-55, 211662-56, 211662-57, 211662-58, 211662-59, 211662-6, 211662-60, 211662-61, 211662-62, 211662-63, 211662-64, 211662-65, 211662-66, 211662-67, 211662-68, 211662-69, 211662-7, 211662-70, 211662-71, 211662-72, 211662-73, 211662-74, 211662-75, 211662-76, 211662-77, 211662-78, 211662-79, 211662-8, 211662-80, 211662-81, 211662-82, 211662-83, 211662-84, 211662-85, 211662-86, 211662-87, 211662-88, 211662-89, 211662-9, 211662-90, 211662-91 211613-1, 211613-10, 211613-100, 211613-101, 211613-102, 211613-103, 211613-104, 211613-105, 211613-106, 211613-107, 211613-108, 211613-109, 211613-11, 211613-110, 211613-12, 211613-13, 211613-14, 211613-15, 211613-16, 211613-17, 211613-18, 211613-19, 211613-2, 211613-20, 211613-21, 211613-22, 211613-23, 211613-24, 211613-25, 211613-26, 211613-27, 211613-28, 211613-29, 211613-3, 211613-30, 211613-31, 211613-32, 211613-33, 211613-34, 211613-35, 211613-36, 211613-37, 211613-38, 211613-39, 211613-4, 211613-40, 211613-41, 211613-42, 211613-43, 211613-44, 211613-45, 211613-46, 211613-47, 211613-48, 211613-49, 211613-5, 211613-50, 211613-51, 211613-52, 211613-53, 211613-54, 211613-55, 211613-56, 211613-57, 211613-58, 211613-59, 211613-6, 211613-60, 211613-61, 211613-62, 211613-63, 211613-64, 211613-65, 211613-66, 211613-67, 211613-68, 211613-69, 211613-7, 211613-70, 211613-71, 211613-72, 211613-73, 211613-74, 211613-75, 211613-76, 211613-77, 211613-78, 211613-79, 211613-8, 211613-80, 211613-81, 211613-82, 211613-83, 211613-84, 211613-85, 211613-86, 211613-87, 211613-88, 211613-89, 211613-9, 211613-90, 211613-91, 211613-92, 211613-93, 211613-94, 211613-95, 211613-96, 211613-97, 211613-98, 211613-99 211577-1, 211577-10, 211577-11, 211577-12, 211577-13, 211577-14, 211577-15, 211577-16, 211577-17, 211577-18, 211577-19, 211577-2, 211577-20, 211577-21, 211577-22, 211577-23, 211577-24, 211577-25, 211577-26, 211577-27, 211577-28, 211577-29, 211577-3, 211577-30, 211577-31, 211577-32, 211577-33, 211577-34, 211577-35, 211577-36, 211577-37, 211577-38, 211577-39, 211577-4, 211577-40, 211577-41, 211577-42, 211577-43, 211577-44, 211577-45, 211577-46, 211577-47, 211577-48, 211577-49, 211577-5, 211577-50, 211577-51, 211577-52, 211577-53, 211577-54, 211577-55, 211577-56, 211577-57, 211577-58, 211577-59, 211577-6, 211577-60, 211577-61, 211577-62, 211577-63, 211577-64, 211577-65, 211577-66, 211577-67, 211577-68, 211577-69, 211577-7, 211577-70, 211577-71, 211577-72, 211577-73, 211577-74, 211577-75, 211577-76, 211577-77, 211577-78, 211577-79, 211577-8, 211577-80, 211577-81, 211577-82, 211577-83, 211577-84, 211577-85, 211577-86, 211577-87, 211577-88, 211577-89, 211577-9, 211577-90, 211577-91, 211577-92, 211577-93, 211577-94, 211577-95, 211577-96, 211577-97, 211577-98, 211577-99 211576-1, 211576-10, 211576-11, 211576-12, 211576-13, 211576-14, 211576-15, 211576-16, 211576-17, 211576-18, 211576-19, 211576-2, 211576-20, 211576-23, 211576-24, 211576-25, 211576-26, 211576-27, 211576-28, 211576-29, 211576-30, 211576-31, 211576-33, 211576-34, 211576-35, 211576-36, 211576-37, 211576-38, 211576-39, 211576-41, 211576-42, 211576-43, 211576-44, 211576-45, 211576-46, 211576-47, 211576-48, 211576-49, 211576-5, 211576-51, 211576-52, 211576-53, 211576-54, 211576-55, 211576-58, 211576-59, 211576-6, 211576-60, 211576-61, 211576-63, 211576-64, 211576-66, 211576-67, 211576-68, 211576-69, 211576-7, 211576-70, 211576-71, 211576-76, 211576-78, 211576-79, 211576-8, 211576-80, 211576-81, 211576-82, 211576-83, 211576-84, 211576-85, 211576-86, 211576-87, 211576-89, 211576-9, 211576-90, 211576-91, 211576-92, 211576-94 2B10865-1, 2B10865-2, 2B10865-3, 2B10865-4, 2B10865-5, 2B10865-6, 2B10865-7, 2B10865-8, 2B10865-9, 2B10865-10, 2B10865-11, 2B10865-12, 2B10865-13, 2B10865-14, 2B10865-15, 2B10865-16, 2B10865-17, 2B10865-18, 2B10865-19, 2B10865-20, 2B10865-21, 2B10865-22, 2B10865-23, 2B10865-24, 2B10865-25, 2B10865-26, 2B10865-27, 2B10865-28, 2B10865-29, 2B10865-30, 2B10865-31, 2B10865-32, 2B10865-33, 2B10865-34, 2B10865-35, 2B10865-36, 2B10865-37, 2B10865-38, 2B10865-39, 2B10865-40, 2B10865-41, 2B10865-42, 2B10865-43, 2B10865-44, 2B10865-45, 2B10865-46, 2B10865-47, 2B10865-48, 2B10865-49, 2B10865-50, 2B10865-51, 2B10865-52, 2B10865-53, 2B10865-54, 2B10865-55, 2B10865-56, 2B10865-57, 2B10865-58, 2B10865-59, 2B10865-60, 2B10865-61, 2B10865-62, 2B10865-63, 2B10865-64, 2B10865-65, 2B10865-66, 2B10865-67, 2B10865-68, 2B10865-69, 2B10865-70, 2B10865-71, 2B10865-72, 2B10865-73… (truncated, 21140 characters total — see the official FDA record for the full value)
Recalling firm:
Stimwave Technologies Inc
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