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Recalls affecting New Mexico

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

16,356 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)
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)
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)
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 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.

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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.

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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

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

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 #: 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

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 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 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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▸Full report

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.
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
▸Full report

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
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
▸Full report

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
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
▸Full report

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
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-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.

ALL 50 STATES
▸Full report

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

Recall #:
86115
Lot/product code:
1. STQ4 RCV A0 US: Serial numbers: 211766-1, 211766-10, 211766-11, 211766-12, 211766-13, 211766-14, 211766-15, 211766-16, 211766-17, 211766-18, 211766-19, 211766-2, 211766-20, 211766-21, 211766-22, 211766-23, 211766-24, 211766-25, 211766-26, 211766-27, 211766-28, 211766-29, 211766-3, 211766-30, 211766-31, 211766-32, 211766-33, 211766-34, 211766-35, 211766-36, 211766-37, 211766-38, 211766-39, 211766-4, 211766-40, 211766-41, 211766-42, 211766-43, 211766-44, 211766-45, 211766-46, 211766-47, 211766-48, 211766-49, 211766-5, 211766-50, 211766-51, 211766-52, 211766-53, 211766-54, 211766-55, 211766-56, 211766-57, 211766-58, 211766-59, 211766-6, 211766-60, 211766-61, 211766-62, 211766-63, 211766-64, 211766-65, 211766-66, 211766-67, 211766-68, 211766-69, 211766-7, 211766-70, 211766-71, 211766-72, 211766-73, 211766-74, 211766-75, 211766-76, 211766-77, 211766-78, 211766-79, 211766-8, 211766-80, 211766-81, 211766-82, 211766-83, 211766-84, 211766-85, 211766-86, 211766-87, 211766-88, 211766-89, 211766-9, 211766-90, 211766-91, 211766-92, 211766-93, 211766-94, 211766-95, 211670-1, 211670-1, 211670-10, 211670-11, 211670-12, 211670-13, 211670-14, 211670-15, 211670-16, 211670-17, 211670-18, 211670-19, 211670-2, 211670-20, 211670-21, 211670-22, 211670-23, 211670-24, 211670-25, 211670-26, 211670-27, 211670-28, 211670-29, 211670-3, 211670-30, 211670-31, 211670-32, 211670-33, 211670-34, 211670-35, 211670-36, 211670-37, 211670-38, 211670-39, 211670-4, 211670-40, 211670-41, 211670-42, 211670-43, 211670-44, 211670-45, 211670-46, 211670-47, 211670-48, 211670-49, 211670-5, 211670-50, 211670-6, 211670-7, 211670-8, 211670-9, 211669-1, 211669-1, 211669-10, 211669-11, 211669-12, 211669-13, 211669-14, 211669-15, 211669-16, 211669-17, 211669-18, 211669-19, 211669-2, 211669-20, 211669-21, 211669-22, 211669-23, 211669-24, 211669-25, 211669-26, 211669-27, 211669-28, 211669-29, 211669-3, 211669-30, 211669-31, 211669-32, 211669-33, 211669-34, 211669-35, 211669-36, 211669-37, 211669-38, 211669-39, 211669-4, 211669-40, 211669-41, 211669-42, 211669-43, 211669-44, 211669-45, 211669-46, 211669-47, 211669-48, 211669-49, 211669-5, 211669-50, 211669-51, 211669-52, 211669-53, 211669-54, 211669-55, 211669-56, 211669-57, 211669-58, 211669-59, 211669-6, 211669-60, 211669-61, 211669-62, 211669-63, 211669-64, 211669-65, 211669-66, 211669-67, 211669-68, 211669-69, 211669-7, 211669-70, 211669-71, 211669-72, 211669-73, 211669-74, 211669-75, 211669-76, 211669-77, 211669-78, 211669-79, 211669-8, 211669-80, 211669-81, 211669-82, 211669-83, 211669-84, 211669-85, 211669-86, 211669-87, 211669-88, 211669-89, 211669-9, 211669-90, 211669-91, 211669-92, 211669-93, 211669-94, 211669-95, 211669-96, 211669-97, 211669-98, 211669-99, 211569-1, 211569-1, 211569-10, 211569-11, 211569-12, 211569-13, 211569-14, 211569-15, 211569-16, 211569-17, 211569-18, 211569-19, 211569-2, 211569-20, 211569-21, 211569-22, 211569-23, 211569-27, 211569-28, 211569-29, 211569-3, 211569-30, 211569-31, 211569-32, 211569-33, 211569-34, 211569-35, 211569-36, 211569-37, 211569-38, 211569-39, 211569-4, 211569-40, 211569-41, 211569-42, 211569-43, 211569-44, 211569-45, 211569-47, 211569-49, 211569-5, 211569-50, 211569-51, 211569-52, 211569-53, 211569-54, 211569-55, 211569-56, 211569-57, 211569-58, 211569-59, 211569-60, 211569-61, 211569-65, 211569-66, 211569-7, 211569-70, 211569-71, 211569-72, 211569-73, 211569-74, 211569-75, 211569-76, 211569-77, 211569-78, 211569-79, 211569-8, 211569-80, 211569-81, 211569-82, 211569-83, 211569-84, 211569-85, 211569-86, 211569-87, 211569-9, 211188-1, 211188-1, 211188-10, 211188-11, 211188-12, 211188-13, 211188-14, 211188-15, 211188-16, 211188-17, 211188-18, 211188-19, 211188-2, 211188-20, 211188-21, 211188-22, 211188-23, 211188-24, 211188-25, 211188-26, 211188-27, 211188-28, 211188-29, 211188-3, 211188-30, 211188-31, 211188-32, 211188-33, 211188-34, 211188-35, 211188-36, 211188-37, 211188-38, 211188-39, 211188-4, 211188-40, 211188-41, 211188-42, 211188-43, 211188-44, 211188-45, 211188-46, 211188-47, 211188-48, 211188-49, 211188-5, 211188-50, 211188-51, 211188-52, 211188-53, 211188-54, 211188-55, 211188-56, 211188-57, 211188-58, 211188-59, 211188-6, 211188-60, 211188-61, 211188-62, 211188-63, 211188-64, 211188-65, 211188-66, 211188-67, 211188-68, 211188-69, 211188-7, 211188-70, 211188-71, 211188-72, 211188-73, 211188-74, 211188-75, 211188-76, 211188-8, 211188-9, 211087-100, 211087-101, 211087-102, 211087-103, 211087-104, 211087-105, 211087-106, 211087-107, 211087-81, 211087-82, 211087-83, 211087-84, 211087-85, 211087-86, 211087-87, 211087-88, 211087-89, 211087-90, 211087-91, 211087-92, 211087-93, 211087-94, 211087-95, 211087-96, 211087-97, 211087-98, 211087-99, 211054-1, 211054-10, 211054-100, 211054-101, 211054-102, 211054-103, 211054-104, 211054-105, 211054-106, 211054-107, 211054-108, 211054-109, 211054-11, 211054-110, 211054-111, 211054-112, 211054-113, 211054-114, 211054-115, 211054-116, 211054-117, 211054-118, 211054-119, 211054-12, 211054-120, 211054-13, 211054-14, 2… (truncated, 30266 characters total — see the official FDA record for the full value)
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
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.

ALL 50 STATES
▸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
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-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.

ALL 50 STATES
▸Full report

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

Recall #:
86115
Lot/product code:
1. STQ4-SPR-B0 US, Serial Numbers: 211668-1, 211668-10, 211668-11, 211668-12, 211668-13, 211668-14, 211668-15, 211668-16, 211668-17, 211668-18, 211668-19, 211668-2, 211668-20, 211668-21, 211668-22, 211668-23, 211668-24, 211668-25, 211668-26, 211668-27, 211668-28, 211668-29, 211668-3, 211668-30, 211668-31, 211668-32, 211668-33, 211668-34, 211668-35, 211668-36, 211668-37, 211668-38, 211668-39, 211668-4, 211668-40, 211668-41, 211668-42, 211668-43, 211668-44, 211668-45, 211668-46, 211668-47, 211668-48, 211668-49, 211668-5, 211668-50, 211668-51, 211668-52, 211668-53, 211668-54, 211668-55, 211668-56, 211668-57, 211668-58, 211668-59, 211668-6, 211668-60, 211668-61, 211668-62, 211668-63, 211668-64, 211668-65, 211668-66, 211668-67, 211668-68, 211668-69, 211668-7, 211668-70, 211668-71, 211668-72, 211668-73, 211668-74, 211668-75, 211668-76, 211668-77, 211668-78, 211668-79, 211668-8, 211668-80, 211668-81, 211668-82, 211668-83, 211668-84, 211668-85, 211668-86, 211668-87, 211668-88, 211668-89, 211668-9, 211668-90, 211668-91, 211668-92, 211570-1, 211570-10, 211570-11, 211570-12, 211570-13, 211570-14, 211570-15, 211570-16, 211570-17, 211570-18, 211570-19, 211570-2, 211570-20, 211570-21, 211570-22, 211570-23, 211570-24, 211570-25, 211570-26, 211570-27, 211570-28, 211570-29, 211570-3, 211570-30, 211570-31, 211570-32, 211570-33, 211570-34, 211570-35, 211570-36, 211570-37, 211570-38, 211570-39, 211570-4, 211570-40, 211570-41, 211570-42, 211570-43, 211570-44, 211570-45, 211570-46, 211570-47, 211570-48, 211570-49, 211570-5, 211570-50, 211570-51, 211570-52, 211570-53, 211570-54, 211570-55, 211570-56, 211570-57, 211570-58, 211570-59, 211570-6, 211570-60, 211570-61, 211570-62, 211570-63, 211570-64, 211570-65, 211570-66, 211570-67, 211570-68, 211570-69, 211570-7, 211570-70, 211570-71, 211570-72, 211570-73, 211570-74, 211570-75, 211570-76, 211570-77, 211570-78, 211570-79, 211570-8, 211570-80, 211570-81, 211570-82, 211570-83, 211570-84, 211570-85, 211570-86, 211570-87, 211570-88, 211570-89, 211570-9, 211569-69, 211187-1, 211187-10, 211187-11, 211187-12, 211187-13, 211187-14, 211187-15, 211187-16, 211187-17, 211187-18, 211187-19, 211187-2, 211187-20, 211187-21, 211187-22, 211187-23, 211187-24, 211187-25, 211187-26, 211187-27, 211187-28, 211187-29, 211187-3, 211187-30, 211187-31, 211187-32, 211187-33, 211187-34, 211187-35, 211187-36, 211187-37, 211187-38, 211187-39, 211187-4, 211187-40, 211187-41, 211187-42, 211187-43, 211187-44, 211187-45, 211187-46, 211187-47, 211187-48, 211187-49, 211187-5, 211187-50, 211187-51, 211187-52, 211187-53, 211187-54, 211187-55, 211187-56, 211187-57, 211187-58, 211187-59, 211187-6, 211187-60, 211187-61, 211187-62, 211187-63, 211187-64, 211187-65, 211187-66, 211187-67, 211187-68, 211187-69, 211187-7, 211187-70, 211187-71, 211187-72, 211187-73, 211187-8, 211187-9, 211128-10, 211128-11, 211128-3, 211128-4, 211128-5, 211128-6, 211128-7, 211128-8, 211128-9, 210966-1, 210966-10, 210966-11, 210966-12, 210966-13, 210966-14, 210966-15, 210966-16, 210966-17, 210966-18, 210966-19, 210966-2, 210966-20, 210966-21, 210966-22, 210966-23, 210966-24, 210966-25, 210966-26, 210966-27, 210966-28, 210966-29, 210966-3, 210966-30, 210966-31, 210966-32, 210966-33, 210966-34, 210966-35, 210966-36, 210966-37, 210966-38, 210966-39, 210966-4, 210966-40, 210966-41, 210966-42, 210966-43, 210966-44, 210966-5, 210966-6, 210966-7, 210966-8, 210966-9, 210960-1, 210960-10, 210960-11, 210960-12, 210960-13, 210960-14, 210960-15, 210960-16, 210960-17, 210960-18, 210960-19, 210960-2, 210960-20, 210960-21, 210960-22, 210960-23, 210960-24, 210960-25, 210960-26, 210960-27, 210960-28, 210960-29, 210960-3, 210960-30, 210960-31, 210960-32, 210960-33, 210960-34, 210960-35, 210960-36, 210960-37, 210960-38, 210960-39, 210960-4, 210960-40, 210960-41, 210960-42, 210960-43, 210960-44, 210960-45, 210960-46, 210960-47, 210960-48, 210960-49, 210960-5, 210960-50, 210960-51, 210960-52, 210960-53, 210960-54, 210960-55, 210960-56, 210960-57, 210960-58, 210960-59, 210960-6, 210960-60, 210960-61, 210960-62, 210960-63, 210960-64, 210960-65, 210960-66, 210960-67, 210960-68, 210960-69, 210960-7, 210960-8, 210960-9, 210049-1, 210049-10, 210049-11, 210049-12, 210049-13, 210049-14, 210049-15, 210049-16, 210049-17, 210049-18, 210049-19, 210049-2, 210049-20, 210049-21, 210049-3, 210049-4, 210049-5, 210049-6, 210049-7, 210049-8, 210049-9, 210028-1, 210028-10, 210028-11, 210028-12, 210028-13, 210028-14, 210028-15, 210028-16, 210028-17, 210028-18, 210028-19, 210028-2, 210028-20, 210028-21, 210028-22, 210028-23, 210028-24, 210028-25, 210028-26, 210028-27, 210028-28, 210028-29, 210028-3, 210028-30, 210028-31, 210028-32, 210028-33, 210028-34, 210028-35, 210028-36, 210028-37, 210028-38, 210028-39, 210028-4, 210028-40, 210028-41, 210028-42, 210028-43, 210028-44, 210028-45, 210028-46, 210028-47, 210028-48, 210028-49, 210028-5, 210028-50, 210028-51, 210028-52, 210028-53, 210028-54, 210028-55, 210028-56, 210028-57, 210028-58, 210028-59, 210028-6, 210028-60, 210028-61, 210028-62, 2100… (truncated, 24793 characters total — see the official FDA record for the full value)
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2020

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - 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-TRL-BO-US, Serial Numbers: 211666-1, 211666-10, 211666-11, 211666-12, 211666-13, 211666-14, 211666-15, 211666-16, 211666-17, 211666-18, 211666-19, 211666-2, 211666-20, 211666-21, 211666-22, 211666-23, 211666-24, 211666-25, 211666-26, 211666-27, 211666-28, 211666-29, 211666-3, 211666-30, 211666-31, 211666-32, 211666-33, 211666-34, 211666-35, 211666-36, 211666-37, 211666-38, 211666-39, 211666-4, 211666-40, 211666-41, 211666-42, 211666-43, 211666-44, 211666-45, 211666-46, 211666-47, 211666-48, 211666-49, 211666-5, 211666-50, 211666-51, 211666-52, 211666-53, 211666-54, 211666-55, 211666-56, 211666-57, 211666-58, 211666-59, 211666-6, 211666-60, 211666-61, 211666-62, 211666-63, 211666-64, 211666-65, 211666-66, 211666-67, 211666-68, 211666-69, 211666-7, 211666-70, 211666-71, 211666-72, 211666-73, 211666-74, 211666-75, 211666-76, 211666-77, 211666-78, 211666-79, 211666-8, 211666-80, 211666-81, 211666-82, 211666-83, 211666-84, 211666-85, 211666-86, 211666-87, 211666-88, 211666-89, 211666-9, 211666-90, 211666-91, 211666-92, 211666-93, 211666-94, 211666-95, 211666-96, 211666-97, 211666-98 211614-1, 211614-10, 211614-11, 211614-12, 211614-13, 211614-14, 211614-15, 211614-16, 211614-17, 211614-18, 211614-19, 211614-2, 211614-20, 211614-21, 211614-22, 211614-23, 211614-24, 211614-25, 211614-26, 211614-27, 211614-28, 211614-29, 211614-3, 211614-30, 211614-31, 211614-32, 211614-33, 211614-34, 211614-35, 211614-36, 211614-37, 211614-38, 211614-39, 211614-4, 211614-40, 211614-41, 211614-42, 211614-43, 211614-44, 211614-45, 211614-46, 211614-47, 211614-48, 211614-49, 211614-5, 211614-50, 211614-51, 211614-52, 211614-53, 211614-54, 211614-55, 211614-56, 211614-57, 211614-58, 211614-59, 211614-6, 211614-60, 211614-61, 211614-62, 211614-63, 211614-64, 211614-65, 211614-66, 211614-67, 211614-68, 211614-69, 211614-7, 211614-70, 211614-71, 211614-72, 211614-73, 211614-74, 211614-75, 211614-76, 211614-77, 211614-78, 211614-79, 211614-8, 211614-80, 211614-81, 211614-82, 211614-83, 211614-84, 211614-85, 211614-86, 211614-87, 211614-88, 211614-89, 211614-9, 211614-90, 211614-91, 211614-92, 211614-93, 211614-94, 211614-95 , 211579-1, 211579-10, 211579-11, 211579-12, 211579-13, 211579-14, 211579-15, 211579-16, 211579-17, 211579-18, 211579-19, 211579-2, 211579-20, 211579-21, 211579-22, 211579-23, 211579-24, 211579-25, 211579-26, 211579-30, 211579-31, 211579-32, 211579-33, 211579-34, 211579-35, 211579-36, 211579-37, 211579-38, 211579-4, 211579-40, 211579-41, 211579-42, 211579-43, 211579-45, 211579-46, 211579-49, 211579-5, 211579-50, 211579-51, 211579-52, 211579-53, 211579-54, 211579-55, 211579-56, 211579-57, 211579-58, 211579-59, 211579-6, 211579-61, 211579-62, 211579-63, 211579-64, 211579-65, 211579-66, 211579-67, 211579-68, 211579-69, 211579-7, 211579-70, 211579-71, 211579-72, 211579-73, 211579-74, 211579-75, 211579-76, 211579-77, 211579-78, 211579-79, 211579-8, 211579-80, 211579-81, 211579-82, 211579-83, 211579-84, 211579-85, 211579-86, 211579-87, 211579-88, 211579-89, 211579-9, 211579-90, 211579-91, 211579-95, 211579-97, 211579-98 211578-1, 211578-10, 211578-11, 211578-12, 211578-13, 211578-14, 211578-15, 211578-16, 211578-17, 211578-18, 211578-19, 211578-2, 211578-20, 211578-21, 211578-22, 211578-23, 211578-24, 211578-25, 211578-26, 211578-27, 211578-28, 211578-29, 211578-3, 211578-30, 211578-31, 211578-32, 211578-33, 211578-34, 211578-35, 211578-36, 211578-37, 211578-38, 211578-39, 211578-4, 211578-40, 211578-41, 211578-42, 211578-43, 211578-44, 211578-45, 211578-46, 211578-47, 211578-48, 211578-49, 211578-5, 211578-50, 211578-51, 211578-52, 211578-53, 211578-54, 211578-55, 211578-56, 211578-57, 211578-58, 211578-59, 211578-6, 211578-60, 211578-61, 211578-62, 211578-63, 211578-64, 211578-65, 211578-66, 211578-67, 211578-68, 211578-69, 211578-7, 211578-70, 211578-71, 211578-72, 211578-73, 211578-74, 211578-75, 211578-76, 211578-77, 211578-78, 211578-79, 211578-8, 211578-80, 211578-81, 211578-82, 211578-83, 211578-84, 211578-85, 211578-86, 211578-87, 211578-88, 211578-89, 211578-9, 211578-90, 211578-91, 211578-92 2B10866-1, 2B10866-2, 2B10866-3, 2B10866-4, 2B10866-5, 2B10866-6, 2B10866-7, 2B10866-8, 2B10866-9, 2B10866-10, 2B10866-11, 2B10866-12, 2B10866-13, 2B10866-14, 2B10866-15, 2B10866-16, 2B10866-17, 2B10866-18, 2B10866-19, 2B10866-20, 2B10866-21, 2B10866-22, 2B10866-23, 2B10866-24, 2B10866-25, 2B10866-26, 2B10866-27, 2B10866-28, 2B10866-29, 2B10866-30, 2B10866-31, 2B10866-32, 2B10866-33, 2B10866-34, 2B10866-35, 2B10866-36, 2B10866-37, 2B10866-38, 2B10866-39, 2B10866-40, 2B10866-41, 2B10866-42, 2B10866-43, 2B10866-44, 2B10866-45, 2B10866-46, 2B10866-47, 2B10866-48, 2B10866-49, 2B10866-50, 2B10866-51, 2B10866-52, 2B10866-53, 2B10866-54, 2B10866-55, 2B10866-56, 2B10866-57, 2B10866-58, 2B10866-59, 2B10866-60, 2B10866-61, 2B10866-62, 2B10866-63, 2B10866-64, 2B10866-65, 2B10866-66, 2B10866-67, 2B10866-68, 2B10866-69, 2B10866-70, 2B10866-71, 2B10866-72, 2B10866-73, 2B10866-74, 2B10866-75, 2B10866-76, 2B10866-77, 2B10866-7… (truncated, 16111 characters total — see the official FDA record for the full value)
Recalling firm:
Stimwave Technologies Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 21, 2020

Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.

Disposable face masks labeled as non-medical were distributed to customers expecting medical use face masks.

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

Recall #:
86380
Lot/product code:
Mfr. Lot No. EM20AP01, EM20AP02, EM20AP03, EM20MA01
Recalling firm:
BEYOND WHITE SPA LLC D.B.A. EZYWIPE OF AMERCIA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 22, 2020

CombiDiagnost R90 Software Version R1.0 and R1.1

Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under exposed image.

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

Recall #:
88393
Lot/product code:
Model 706100
Recalling firm:
Philips Medical Systems Gmbh, DMC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 22, 2020

POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.

Multiple lots being recalled due to a product design issue

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

Recall #:
86099
Lot/product code:
Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689
Recalling firm:
Smith & Nephew Orthopaedics AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2020

NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instruments, and hand-held External Remote Controller (ERC).

During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.

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

Recall #:
86150
Lot/product code:
Item Number: PA1160-10D400-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9011815AAA 9021510AAA 9022225AAA 9072512AAA  Item Number: PA1161-10D400-7 Description: ANTE FEMUR TROCH 10DEG13MM X 400MM, 7/10CM ST Lot/Serial Number: 9012506AAA 9061720AAA  Item Number: PA1160-10SJ360-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9013007AAA 9030706AAA 9031514AAA 9042208AAA 9050811AAA 9072218AAA  Item Number: PA1159-10SJ360-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 360MM, 7/10CM STK Lot/Serial Number: 9020607AAA 9022815AAA 9050211AAA 9071604AAA  Item Number: PA1160-90SJ340-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 340MM, 7/9CM ST Lot/Serial Number: 9020608AAA 9052110AAA 9052906AAA 9072217AAA  Item Number: PA1160-80SJ320-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 320MM, 7/8CM ST Lot/Serial Number: 9021222AAA  Item Number: PA1159-80SJ320-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 320MM, 7/8CM STK Lot/Serial Number: 9021223AAA  Item Number: PA1160-70SJ300-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 300MM, 7/7CM ST Lot/Serial Number: 9021224AAA  Item Number: PA1160-10D380-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9021512AAA 9072513AAA 9072912AAA 9080106AAA  Item Number: PA1159-90SJ340-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 340MM, 7/9CM STK Lot/Serial Number: 9020609AAA 9052208AAA 9071603AAA  Item Number: PA1161-10X380-7 Description: RETRO FEMUR STRAIGHT13MM X 380MM, 7/10CM ST Lot/Serial Number: 9021913AAA  Item Number: PA1160-10X360-7 Description: RETRO FEMUR STRAIGHT11.5MM X 360MM, 7/10CM ST Lot/Serial Number: 9022227AAA  Item Number: PA1161-10X360-7 Description: RETRO FEMUR STRAIGHT13MM X 360MM, 7/10CM ST Lot/Serial Number: 9022226AAA  Item Number: PA1160-10SJ400-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9020809AAA  Item Number: PA1159-10SJ400-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 400MM, 7/10CM STK Lot/Serial Number: 9020810AAA  Item Number: PA1160-10SJ380-7 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9022813AAA 9042506AAA  Item Number: PA1160-10B380-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9021513AAA  Item Number: PA1160-10B360-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9021514AAA  Item Number: PA1159-10SJ380-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 380MM, 7/10CM STK Lot/Serial Number: 9031310AAA 9071605AAA  Item Number: PA1160-10D360-7 Description: ANTE FEMUR TROCH 10DEG11.5MM X 360MM 7/10CM ST Lot/Serial Number: 9022816AAA  Item Number: PA1160-60SJ280-6 Description: ANTE TIBIA 10DEG, 3-HOLE11.5MM X 280MM, 6/6CM ST Lot/Serial Number: 9021914AAA  Item Number: PA1159-70SJ300-7 Description: ANTE TIBIA 10DEG, 3-HOLE10MM X 300MM, 7/7CM STK Lot/Serial Number: 9021915AAA  Item Number: PA1160-90X340-7 Description: RETRO FEMUR STRAIGHT11.5MM X 340MM, 7/9CM ST Lot/Serial Number: 9041617AAA  Item Number: PA1160-10X380-7 Description: RETRO FEMUR STRAIGHT11.5MM X 380MM 7/10CM ST Lot/Serial Number: 9041618AAA  Item Number: PA1159-10D380-7 Description: ANTE FEMUR TROCH 10DEG10MM X 380MM, 7/10CM STK Lot/Serial Number: 9042211AAA  Item Number: PA1161-10B380-7 Description: ANTE FEMUR PIRIFOMIS13MM X 380MM, 7/10CM ST Lot/Serial Number: 9052305AAA 9061009AAA  Item Number: PA1161-10B400-7 Description: ANTE FEMUR PIRIFOMIS13MM X 400MM, 7/10CM ST Lot/Serial Number: 9052306AAA  Item Number: PA1160-10B400-7 Description: ANTE FEMUR PIRIFOMIS11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9053110AAA  Item Number: PA1160-10X400-7 Description: RETRO FEMUR STRAIGHT11.5MM X 400MM 7/10CM ST Lot/Serial Number: 9061208AAA  Item Number: PA1161-10X400-7 Description: RETRO FEMUR STRAIGHT13MM X 400MM, 7/10CM ST Lot/Serial Number: 9061209AAA  Item Number: PA1161-10B400-7 Description: ANTE FEMUR PIRIFOMIS13MM X 400MM, 7/10CM ST Lot/Serial Number: 9061008AAA  Item Number: PA1159-80X320-7 Description: RETO FEMUR STRAIGHT10MM X 320MM, 7/8CM STK Lot/Serial Number: 9062416AAA  Item Number: PA1161-10D380-7 Description: ANTE FEMUR TROCH 10DEG13MM X 380MM, 7/10CM ST Lot/Serial Number: 9061721AAA 9071825AAA  Item Number: PA1159-10B400-7 Description: ANTE FEMUR PIRIFORMIS10MM X 400MM, 7/10CM STK Lot/Serial Number: 9072219AAA  Item Number: PA1159-10D400-7 Description: ANTE FEMUR TROCH 10DEG10MM X 400MM, 7/10CM STK Lot/Serial Number: 9072220AAA 9072911AAA  Item Number: PA1159-10B380-7 Description: ANTE FEMUR PIRIFORMIS10MM X 380MM, 7/10CM STK Lot/Serial Number: 9072221AAA
Recalling firm:
Nuvasive Specialized Orthopedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

Potential Endotoxin Contamination

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

Recall #:
85823
Lot/product code:
Kit Lot Number:  3000079504 3000051211 3000051213 3000051214 3000051215 3000051216 3000051217 3000055314 3000056699 3000057319 3000057968 3000058129 3000062638 3000064726 3000068107 3000068108 3000071286 3000072715 3000072716 3000087745 3000090529 3000090660 3000092776 3000076631 3000077754 3000077755 3000080370 3000080371 3000080372 3000080373 3000080374 3000080375 3000080369 3000083330 3000084963 3000084964 3000092777 3000092778 3000095472 3000096375 3000096377 3000096378 3000098752 3000099588 3000099589
Recalling firm:
Datascope Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled July 27, 2020

Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.

Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible intubation endoscopes with total lumen lengths greater than 850mm. Incompletely sterilized endoscopes might introduce infectious agents into patient airways, resulting in infection.

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

Recall #:
86009
Lot/product code:
Instruction Manual Version: 08/2018
Recalling firm:
Karl Storz Endoscopy
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