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Recalls affecting Nevada

Data last updated: September 11, 2026 at 1:08 PM UTC

16,602 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

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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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)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

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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.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MMQ007 21BMQ007 21CMQ008 21DMQ001 21EMQ003 21FMQ007. UDI: 50192253006191 (cs) 10192253006193 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MBQ001 21ABQ001 21ABQ002 21BBQ002 21BBQ003 21BBQ004 21BBQ005 21CBQ002 21CBQ003 21DBQ003 21DBQ004 21DBQ005 21EBQ003 21EBQ004 21EBQ005 21FBQ002 21FBQ003 21FBQ004 21FBQ005 21HBQ001 21HBQ002 21JBQ002 UDI: 50192253018996 (cs) 10192253018998 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50192253018927 (Cs) 10192253018929 (Ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MDQ014 21ADQ007 21CDQ004 21CDQ005 21DDQ001 21DDQ002 21EDQ001 21FDQ001 21GDQ001 21HDQ001 21JDQ003. UDI: 50192253018972 (cs) 10192253018974 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Potential for open packaging seals compromising the sterility of the surgical gowns

ALL 50 STATES
▸Full report

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

Recall #:
89015
Lot/product code:
Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2021

OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

ALL 50 STATES
▸Full report

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

Recall #:
89176
Lot/product code:
Serial no. 0157, 0158 & 0171
Recalling firm:
Haag-Streit USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 3, 2021

OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

ALL 50 STATES
▸Full report

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

Recall #:
89176
Lot/product code:
Serial no. 0005, 0023
Recalling firm:
Haag-Streit USA Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH200223DX (01008406821216511120100821VH200223DX, H41212ZD), VH150287BJ (01008406821216511118010021VH150287BJ, H41212RS), VH200066HU (01008406821216511119120021VH200066HU, H41212ZD), VH200162ER (01008406821216511120071621VH200162ER, H41212ZC), VH20016794 (01008406821216511120071521VH20016794, H41212ZC), VH150601D6 (01008406821216511119011821VH150601D6, H41212ZC), VH200230XX (01008406821216511120071621VH200230XX, H41212ZC), VH200169VK (01008406821216511120071521VH200169VK, H41212ZC), VH200237TC (01008406821216511120071621VH200237TC, H41212ZC), VH200132U6 (01008406821216511120010021VH200132U6, H41212ZC), VH150275W5 (01008406821216511117090021VH150275W5, H41212RS), VH1504669B (01008406821216511118110021VH1504669B, H41212ZC), VH1508481L (01008406821216511119090021VH1508481L, H41212ZC), VH150284N3 (01008406821216511117100021VH150284N3, H41212RS), VH150265SH (01008406821216511117070021VH150265SH, H41212RS), VH1502694X (01008406821216511117070021VH1502694X, H41212RS), VH150433TG (01008406821216511118110021VH150433TG, H41212ZC), VH150968IT (01008406821216511119070021VH150968IT, H41212ZC), VH200286ZF (01008406821216511120082121VH200286ZF, H41212ZC), VH15036053 (01008406821216511118030021VH15036053, H41212RS), VH1503587A (01008406821216511118030021VH1503587A, H41212RS), VH150958Z4 (01008406821216511119060021VH150958Z4, H41212ZC), VH1502743H (01008406821216511117080021VH1502743H, H41212RS), VH150221EE (01008406821216511117090621VH150221EE, H41212RS), VH150909SW (01008406821216511119060021VH150909SW, H41212ZC), VH1509252J (01008406821216511119060021VH1509252J, H41212ZC), VH150620EN (01008406821216511119060021VH150620EN, H41212ZC), VH150902EF (01008406821216511119060021VH150902EF, H41212ZC), VH1509347X (01008406821216511119060021VH1509347X, H41212ZC), VH15083871 (01008406821216511119050021VH15083871, H41212ZC), VH150839JY (01008406821216511119050021VH150839JY, H41212ZC), VH15075671 (01008406821216511119032121VH15075671, H41212ZC), VH150736AR (01008406821216511119032021VH150736AR, H41212ZC), VH150657SF (01008406821216511119030721VH150657SF, H41212ZC), VH150388NZ (01008406821216511118050021VH150388NZ, H41212ZC), VH150617DA (01008406821216511118120021VH150617DA, H41212ZC), VH1503194P (01008406821216511118040021VH1503194P, H41212ZC), VH200346QM (01008406821216511120100821VH200346QM, H41212ZC), VH2003445A (01008406821216511120100821VH2003445A, H41212ZC), VH150610SB (01008406821216511119010021VH150610SB, H41212ZC), VH150289ZR (01008406821216511118010021VH150289ZR, H41212RS), VH150819MK (01008406821216511119050021VH150819MK, H41212ZC), VH150529PP (01008406821216511118120021VH150529PP, H41212ZC), VH150606XW (01008406821216511119090021VH150606XW, H41212ZC), VH1505755D (01008406821216511118120021VH1505755D, H41212ZC), VH150747UN (01008406821216511119032621VH150747UN, H41212ZC), VH200165ZC (01008406821216511120071421VH200165ZC, H41212ZC), VH200170IX (01008406821216511120071521VH200170IX, H41212ZC), VH200228SY (01008406821216511120071521VH200228SY, H41212ZC), VH200239FZ (01008406821216511120071621VH200239FZ, H41212ZC), VH200163VU (01008406821216511120071621VH200163VU, H41212ZC), VH150695BV (01008406821216511119032121VH150695BV, H41212ZC), VH150708AA (01008406821216511119032121VH150708AA, H41212ZC), VH150745T5 (01008406821216511119032121VH150745T5, H41212ZC), VH150754YW (01008406821216511119032121VH150754YW, H41212ZC), VH150286IC (01008406821216511118010021VH150286IC, H41212RS)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.

The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.

ALL 50 STATES
▸Full report

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

Recall #:
88953
Lot/product code:
UDI 00763000185152
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Dual USB"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Nubmer)". VH1602482A (01008406821216511117040721VH1602482A, H41212RK), VH160398U2 (01008406821216511117040021VH160398U2, H41212RK), VH160910MS (01008406821216511117090021VH160910MS, H41212RK), VH160692PU (01008406821216511117060021VH160692PU, H41212RK), VH16072033 (01008406821216511117060021VH16072033, H41212RK), VH164639E1 (01008406821216511119060021VH164639E1, H41212YY), VH165023E4 (01008406821216511119090021VH165023E4, H41212YY), VH26557563 (01008406821216511121071221VH26557563, H41212YY), VH265583RM (01008406821216511121070921VH265583RM, H41212YY), VH2656017N (01008406821216511121070821VH2656017N, H41212YY), VH265638Q4 (01008406821216511121070921VH265638Q4, H41212YY), VH26564046 (01008406821216511121070921VH26564046, H41212YY), VH265645Q7 (01008406821216511121070821VH265645Q7, H41212YY), VH265647U2 (01008406821216511121070921VH265647U2, H41212YY), VH265836ZG (01008406821216511121071221VH265836ZG, H41212YY), VH265838JV (01008406821216511121071221VH265838JV, H41212YY), VH265842CE (01008406821216511121071221VH265842CE, H41212YY), VH265844SA (01008406821216511121070921VH265844SA, H41212YY), VH265845WV (01008406821216511121071221VH265845WV, H41212YY), VH265849MM (01008406821216511121070921VH265849MM, H41212YY), VH265851HS (01008406821216511121071221VH265851HS, H41212YY), VH26585212 (01008406821216511121070921VH26585212, H41212YY), VH265857ZW (01008406821216511121070921VH265857ZW, H41212YY), VH265858LY (01008406821216511121071221VH265858LY, H41212YY), VH265864P5 (01008406821216511121070921VH265864P5, H41212YY), VH1632681A (01008406821216511118100021VH1632681A, H41212YY), VH160462WV (01008406821216511117040021VH160462WV, H41212RK), VH160549FR (01008406821216511117060021VH160549FR, H41212RK), VH16055357 (01008406821216511117060021VH16055357, H41212RK), VH160673KV (01008406821216511117060021VH160673KV, H41212RK), VH160674YQ (01008406821216511117060021VH160674YQ, H41212RK), VH160717US (01008406821216511117060021VH160717US, H41212RK), VH160724UV (01008406821216511117110021VH160724UV, H41212RK), VH160844BL (01008406821216511117110021VH160844BL, H41212RK), VH160851T5 (01008406821216511117110021VH160851T5, H41212RK), VH160879LS (01008406821216511117090021VH160879LS, H41212RK), VH16090735 (01008406821216511117090021VH16090735, H41212RK), VH160911AW (01008406821216511117090021VH160911AW, H41212RK), VH16092049 (01008406821216511117090021VH16092049, H41212RK), VH160934IF (01008406821216511117090021VH160934IF, H41212RK), VH160940WS (01008406821216511117100021VH160940WS, H41212RK), VH160984TC (01008406821216511117100021VH160984TC, H41212RK), VH161007CG (01008406821216511117100021VH161007CG, H41212RK), VH161008JP (01008406821216511117100021VH161008JP, H41212RK), VH161028CS (01008406821216511117100021VH161028CS, H41212RK), VH1610527V (01008406821216511117100021VH1610527V, H41212RK), VH1610803G (01008406821216511117100021VH1610803G, H41212RK), VH161086VQ (01008406821216511117100021VH161086VQ, H41212RK), VH1610908L (01008406821216511117100021VH1610908L, H41212RK), VH16109229 (01008406821216511117100021VH16109229, H41212RK), VH161231L5 (01008406821216511117110021VH161231L5, H41212RK), VH161675YG (01008406821216511118030021VH161675YG, H41212RK), VH162475JG (01008406821216511118100021VH162475JG, H41212YY), VH162998CK (01008406821216511118100021VH162998CK, H41212YY), VH1630084S (01008406821216511118100021VH1630084S, H41212YY), VH1633236I (01008406821216511118110021VH1633236I, H41212YY), VH16065514 (01008406821216511117050021VH16065514, H41212RK), VH162006EW (01008406821216511118030021VH162006EW, H41212RK), VH165572VH (01008406821216511119080021VH165572VH, H41212YY), VH2631208T (01008406821216511120081721VH2631208T, H41212YY), VH263163KT (01008406821216511120081721VH263163KT, H41212YY), VH263287F8 (01008406821216511120081721VH263287F8, H41212YY), VH262239Y9 (01008406821216511120061221VH262239Y9, H41212YY), VH262110GZ (01008406821216511120060221VH262110GZ, H41212YY), VH262109PN (01008406821216511120060221VH262109PN, H41212YY), VH260405KN (01008406821216511119120021VH260405KN, H41212YY), VH261920X9 (01008406821216511120051821VH261920X9, H41212YY), VH263156PR (01008406821216511120091521VH263156PR, H41212YY), VH262014IC (01008406821216511120060221VH262014IC, H41212YY), VH262086QK (01008406821216511120052921VH262086QK, H41212YY), VH261683Q7 (01008406821216511120052921VH261683Q7, H41212YY), VH262773P1 (01008406821216511120070621VH262773P1, H41212YY), VH265406KA (01008406821216511121051821VH265406KA, H41212YY), VH263551YR (01008406821216511120101321VH263551YR, H41212YY), VH2630353P (01008406821216511120101321VH2630353P, H41212YY), VH263549DB (01008406821216511120101321VH263549DB, H41212YY), VH1632534K (01008406821216511118100021VH1632534K, H41212YY), VH160006DB (01008406821216511116080021VH160006DB, H41212RK), VH160022AZ (01008406821216511116080021VH160022AZ, H41212RK), VH264900CN (01008406821216511121030921VH264900CN, H41212YY), VH264904KF (01008406821216511121030921VH264904KF, H41212YY), VH1… (truncated, 5056 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.

The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.

ALL 50 STATES
▸Full report

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

Recall #:
88953
Lot/product code:
UDI 00763000217921
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Sector USB"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH150315TI (01008406821216511118020021VH150315TI, H41212RR), VH15019235 (01008406821216511117033021VH15019235, H41212RR), VH150328FJ (01008406821216511118021321VH150328FJ, H41212RR), VH1503146U (01008406821216511118020921VH1503146U, H41212RR), VH1503356H (01008406821216511118021321VH1503356H, H41212RR), VH150318PI (01008406821216511118020821VH150318PI, H41212RR), VH2006357M (01008406821216511121031721VH2006357M, H41212ZB), VH1505402S (01008406821216511118120021VH1505402S, H41212ZB), VH150277MA (01008406821216511117100021VH150277MA, H41212RR), VH150278XK (01008406821216511119030221VH150278XK, H41212ZB), VH150280EN (01008406821216511117100021VH150280EN, H41212RR), VH15028191 (01008406821216511117100021VH15028191, H41212RR), VH150282CY (01008406821216511117100021VH150282CY, H41212RR), VH150283L3 (01008406821216511117100021VH150283L3, H41212RR), VH150296YP (01008406821216511118010021VH150296YP, H41212RR), VH150298DQ (01008406821216511118010021VH150298DQ, H41212RR), VH150299RZ (01008406821216511118010021VH150299RZ, H41212RR), VH15030049 (01008406821216511118010021VH15030049, H41212RR), VH150301JU (01008406821216511118010021VH150301JU, H41212RR), VH150305E7 (01008406821216511118020021VH150305E7, H41212RR), VH150325R6 (01008406821216511118020021VH150325R6, H41212RR), VH150332EL (01008406821216511118020021VH150332EL, H41212RR), VH150334AV (01008406821216511118020021VH150334AV, H41212RR), VH150356RI (01008406821216511118020021VH150356RI, H41212RR), VH150369TF (01008406821216511118020021VH150369TF, H41212RR), VH150396VW (01008406821216511118050021VH150396VW, H41212ZB), VH150398X2 (01008406821216511118050021VH150398X2, H41212ZB), VH1504078Q (01008406821216511118060021VH1504078Q, H41212ZB), VH150413SH (01008406821216511118060021VH150413SH, H41212ZB), VH1504145M (01008406821216511118060021VH1504145M, H41212ZB), VH150418YP (01008406821216511118060021VH150418YP, H41212ZB), VH15041959 (01008406821216511118110021VH15041959, H41212ZB), VH150498S4 (01008406821216511118110021VH150498S4, H41212ZB), VH1505015I (01008406821216511118110021VH1505015I, H41212ZB), VH1505026L (01008406821216511118110021VH1505026L, H41212ZB), VH150503FG (01008406821216511118110021VH150503FG, H41212ZB), VH150504PC (01008406821216511118110021VH150504PC, H41212ZB), VH150505WS (01008406821216511118110021VH150505WS, H41212ZB), VH150541JB (01008406821216511118120021VH150541JB, H41212ZB), VH150599H5 (01008406821216511119010021VH150599H5, H41212ZB), VH150603Q1 (01008406821216511119010021VH150603Q1, H41212ZB), VH1506321L (01008406821216511119030421VH1506321L, H41212ZB), VH150635LI (01008406821216511119030421VH150635LI, H41212ZB), VH150667SK (01008406821216511119040321VH150667SK, H41212ZB), VH150672TF (01008406821216511119040021VH150672TF, H41212ZB), VH150787F1 (01008406821216511119040021VH150787F1, H41212ZB), VH150788JE (01008406821216511119040021VH150788JE, H41212ZB), VH1503213I (01008406821216511118020021VH1503213I, H41212RR), VH150804V1 (01008406821216511119040021VH150804V1, H41212ZB), VH1506815J (01008406821216511119040021VH1506815J, H41212ZB), VH150409WM (01008406821216511118060021VH150409WM, H41212ZB), VH150753TC (01008406821216511119040421VH150753TC, H41212ZB), VH150421I5 (01008406821216511118080021VH150421I5, H41212ZB), VH200797WX (01008406821216511121090221VH200797WX, H41212ZB), VH150766CY (01008406821216511119050021VH150766CY, H41212ZB), VH20076196 (01008406821216511121090221VH20076196, H41212ZB), VH150520G8 (01008406821216511118120021VH150520G8, H41212ZB), VH2003248W (01008406821216511120091621VH2003248W, H41212ZB), VH150614LJ (01008406821216511119010021VH150614LJ, H41212ZB), VH1508428Q (01008406821216511119050021VH1508428Q, H41212ZB), VH200338JV (01008406821216511120091621VH200338JV, H41212ZB), VH1501821N (01008406821216511117030021VH1501821N, H41212RR), VH200729TM (01008406821216511121080521VH200729TM, H41212ZB)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (Model Number, Labeling, UDI)". VH162804HB (01008406821216511118070021VH162804HB, H41212ZA), VH261412UX (01008406821216511120040021VH261412UX, H41212ZA), VH261635DJ (01008406821216511120040021VH261635DJ, H41212ZA), VH261660DH (01008406821216511120040021VH261660DH, H41212ZA), VH262868PS (01008406821216511120071721VH262868PS, H41212ZA), VH162941AB (01008406821216511118090021VH162941AB, H41212ZA), VH266179UH (01008406821216511121081721VH266179UH, H41212ZA), VH164477C1 (01008406821216511119050021VH164477C1, H41212ZA), VH262930DV (01008406821216511120071721VH262930DV, H41212ZA), VH260225R9 (01008406821216511119120021VH260225R9, H41212ZA), VH16105885 (01008406821216511117100021VH16105885, H41212RN), VH1618109Q (01008406821216511118020021VH1618109Q, H41212RN), VH1618127M (01008406821216511118020021VH1618127M, H41212RN), VH162786AS (01008406821216511118072521VH162786AS, H41212ZA), VH163954E2 (01008406821216511119031921VH163954E2, H41212ZA), VH160716CP (01008406821216511117070021VH160716CP, H41212RN), VH160368VF (01008406821216511117032221VH160368VF, H41212RN), VH164216AP (01008406821216511119032721VH164216AP, H41212ZA), VH261981MJ (01008406821216511120081121VH261981MJ, H41212ZA), VH264256QP (01008406821216511120121821VH264256QP, H41212ZA), VH2657824M (01008406821216511121062321VH2657824M, H41212ZA), VH265885RM (01008406821216511121071621VH265885RM, H41212ZA), VH162822XP (01008406821216511118070021VH162822XP, H41212ZA), VH160402SS (01008406821216511117042421VH160402SS, H41212RN), VH165093DJ (01008406821216511119062821VH165093DJ, H41212ZA), VH261080RY (01008406821216511120030021VH261080RY, H41212ZA), VH261141GX (01008406821216511120030021VH261141GX, H41212ZA), VH162956I3 (01008406821216511118100021VH162956I3, H41212ZA), VH163189T6 (01008406821216511118100021VH163189T6, H41212ZA), VH2602335E (01008406821216511119120021VH2602335E, H41212ZA), VH260243BG (01008406821216511119120021VH260243BG, H41212ZA), VH260265CX (01008406821216511119120021VH260265CX, H41212ZA), VH162420Z9 (01008406821216511118050021VH162420Z9, H41212ZA), VH162788Z1 (01008406821216511118070021VH162788Z1, H41212ZA), VH265125Z4 (01008406821216511121032621VH265125Z4, H41212ZA), VH2600177X (01008406821216511119120021VH2600177X, H41212ZA), VH1632842M (01008406821216511118100021VH1632842M, H41212ZA), VH164854MH (01008406821216511119060021VH164854MH, H41212ZA), VH164938U3 (01008406821216511119060021VH164938U3, H41212ZA), VH262978UW (01008406821216511120073021VH262978UW, H41212ZA), VH2661816S (01008406821216511121081721VH2661816S, H41212ZA), VH160442KT (01008406821216511117050021VH160442KT, H41212RN), VH262836XX (01008406821216511120071621VH262836XX, H41212ZA), VH16263643 (01008406821216511118070021VH16263643, H41212ZA), VH162877XD (01008406821216511118070021VH162877XD, H41212ZA), VH1628794W (01008406821216511118080021VH1628794W, H41212ZA), VH163026KZ (01008406821216511118100021VH163026KZ, H41212ZA), VH163059LM (01008406821216511118100021VH163059LM, H41212ZA), VH163195M6 (01008406821216511118100021VH163195M6, H41212ZA), VH164636LU (01008406821216511119050021VH164636LU, H41212ZA), VH164657PH (01008406821216511119050021VH164657PH, H41212ZA), VH164708TI (01008406821216511119050021VH164708TI, H41212ZA), VH164721SC (01008406821216511119050021VH164721SC, H41212ZA), VH164740QH (01008406821216511119050021VH164740QH, H41212ZA), VH164748TN (01008406821216511119050021VH164748TN, H41212ZA), VH261627JV (01008406821216511120040021VH261627JV, H41212ZA), VH261687Z8 (01008406821216511120042121VH261687Z8, H41212ZA), VH262874VI (01008406821216511120071621VH262874VI, H41212ZA), VH262941EY (01008406821216511120072221VH262941EY, H41212ZA), VH263062I3 (01008406821216511120080421VH263062I3, H41212ZA), VH263682ER (01008406821216511120110221VH263682ER, H41212ZA), VH264146NR (01008406821216511121020421VH264146NR, H41212ZA), VH264255HC (01008406821216511120121821VH264255HC, H41212ZA), VH264671L1 (01008406821216511121020421VH264671L1, H41212ZA), VH265122D9 (01008406821216511121032621VH265122D9, H41212ZA), VH26546198 (01008406821216511121070521VH26546198, H41212ZA), VH2654891A (01008406821216511121061721VH2654891A, H41212ZA), VH265644PM (01008406821216511121070721VH265644PM, H41212ZA), VH265662TN (01008406821216511121061621VH265662TN, H41212ZA), VH265807VN (01008406821216511121070621VH265807VN, H41212ZA), VH2658316S (01008406821216511121070721VH2658316S, H41212ZA), VH265872PG (01008406821216511121072621VH265872PG, H41212ZA), VH265895LA (01008406821216511121072321VH265895LA, H41212ZA), VH265900VF (01008406821216511121071921VH265900VF, H41212ZA), VH265923UV (01008406821216511121080221VH265923UV, H41212ZA), VH265984RH (01008406821216511121080221VH265984RH, H41212ZA), VH265999UL (01008406821216511121080221VH265999UL, H41212ZA), VH266282UU (01008406821216511121091321VH266282UU, H41212ZA), VH162164RM (01008406821216511118050021VH162164RM, H41212ZA), VH2629271Q (01008406821216511120072921VH2629271Q, H41212ZA), VH263002BW (01008406821216511120072821VH263002BW, H412… (truncated, 638059 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.

ALL 50 STATES
▸Full report

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

Recall #:
88953
Lot/product code:
UDI 00763000186265
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH200176M2 (01008406821216511120080721VH200176M2, H41212ZD), VH150224FV (01008406821216511117040421VH150224FV, H41212RT), VH150359UT (01008406821216511118020021VH150359UT, H41212RT), VH150510JG (01008406821216511118110021VH150510JG, H41212ZD), VH150725FX (01008406821216511119031521VH150725FX, H41212ZD), VH150726PL (01008406821216511119031521VH150726PL, H41212ZD), VH150833LB (01008406821216511119050021VH150833LB, H41212ZD), VH2004729L (01008406821216511120122221VH2004729L, H41212ZD), VH200602E1 (01008406821216511121031021VH200602E1, H41212ZD), VH2007327J (01008406821216511121062921VH2007327J, H41212ZD), VH1504296K (01008406821216511118070021VH1504296K, H41212ZD), VH2001141J (01008406821216511120010021VH2001141J, H41212ZD), VH200727M4 (01008406821216511121061421VH200727M4, H41212ZD), VH200416DE (01008406821216511120111221VH200416DE, H41212ZD), VH1505184H (01008406821216511118120021VH1505184H, H41212ZD), VH200022GP (01008406821216511119120021VH200022GP, H41212ZD), VH150208XB (01008406821216511117040421VH150208XB, H41212RT), VH200663IW (01008406821216511121061521VH200663IW, H41212ZD), VH2006663X (01008406821216511121061521VH2006663X, H41212ZD), VH20071415 (01008406821216511121061721VH20071415, H41212ZD), VH200719LG (01008406821216511121061521VH200719LG, H41212ZD), VH150488AN (01008406821216511118110021VH150488AN, H41212ZD), VH200092VS (01008406821216511120010021VH200092VS, H41212ZD), VH200158ZR (01008406821216511120020021VH200158ZR, H41212ZD), VH20078872 (01008406821216511121072321VH20078872, H41212ZD), VH150329VP (01008406821216511118021321VH150329VP, H41212RT), VH200042EG (01008406821216511119120021VH200042EG, H41212ZD), VH1501645D (01008406821216511117052321VH1501645D, H41212RT), VH20049973 (01008406821216511120122221VH20049973, H41212ZD), VH150627JD (01008406821216511119012121VH150627JD, H41212ZD), VH1510213I (01008406821216511119110021VH1510213I, H41212ZD), VH200078CB (01008406821216511119120021VH200078CB, H41212ZD), VH200086VZ (01008406821216511120010021VH200086VZ, H41212ZD), VH200104JD (01008406821216511120030021VH200104JD, H41212ZD), VH2001402U (01008406821216511120020021VH2001402U, H41212ZD), VH200604XJ (01008406821216511121022421VH200604XJ, H41212ZD), VH20076953 (01008406821216511121072221VH20076953, H41212ZD), VH200772N5 (01008406821216511121072221VH200772N5, H41212ZD), VH150304YL (01008406821216511118020221VH150304YL, H41212RT), VH1504811P (01008406821216511118102221VH1504811P, H41212ZD), VH150483QI (01008406821216511118110121VH150483QI, H41212ZD), VH150486BT (01008406821216511118110121VH150486BT, H41212ZD), VH150487IA (01008406821216511118110421VH150487IA, H41212ZD), VH150717E8 (01008406821216511119031321VH150717E8, H41212ZD), VH150524EK (01008406821216511118120021VH150524EK, H41212ZD), VH150814W4 (01008406821216511119050021VH150814W4, H41212ZD), VH150815EB (01008406821216511119050021VH150815EB, H41212ZD), VH1508226B (01008406821216511119050021VH1508226B, H41212ZD), VH1508233A (01008406821216511119050021VH1508233A, H41212ZD), VH1509599D (01008406821216511119060021VH1509599D, H41212ZD), VH200035ND (01008406821216511119120021VH200035ND, H41212ZD), VH200439SJ (01008406821216511120120921VH200439SJ, H41212ZD), VH200668T6 (01008406821216511121061521VH200668T6, H41212ZD), VH200681YL (01008406821216511121061421VH200681YL, H41212ZD), VH2007231C (01008406821216511121061421VH2007231C, H41212ZD), VH200724YY (01008406821216511121061521VH200724YY, H41212ZD), VH200820FQ (01008406821216511121091721VH200820FQ, H41212ZD), VH150631WK (01008406821216511119030021VH150631WK, H41212ZD), VH1506566S (01008406821216511119030021VH1506566S, H41212ZD), VH150666EB (01008406821216511119030021VH150666EB, H41212ZD), VH150694FG (01008406821216511119030021VH150694FG, H41212ZD), VH150705HV (01008406821216511119030021VH150705HV, H41212ZD), VH1503974U (01008406821216511118050021VH1503974U, H41212ZD), VH15096421 (01008406821216511119070021VH15096421, H41212ZD), VH200777KC (01008406821216511121081621VH200777KC, H41212ZD), VH150852UQ (01008406821216511119050021VH150852UQ, H41212ZD), VH150933LR (01008406821216511119060021VH150933LR, H41212ZD), VH20014163 (01008406821216511120020021VH20014163, H41212ZD), VH200246AI (01008406821216511120070621VH200246AI, H41212ZD), VH200661SQ (01008406821216511121061521VH200661SQ, H41212ZD), VH150770V9 (01008406821216511119032621VH150770V9, H41212ZD), VH150685RS (01008406821216511119031521VH150685RS, H41212ZD), VH200643IQ (01008406821216511121030921VH200643IQ, H41212ZD), VH150197TZ (01008406821216511117041021VH150197TZ, H41212RT), VH150556H5 (01008406821216511118120021VH150556H5, H41212ZD), VH1502025B (01008406821216511117041021VH1502025B, H41212RT), VH150463BS (01008406821216511119012521VH150463BS, H41212ZD), VH150476N7 (01008406821216511118100021VH150476N7, H41212ZD), VH150478M9 (01008406821216511118100021VH150478M9, H41212ZD), VH15049949 (01008406821216511118110021VH15049949, H41212ZD), VH150939CY (01008406821216511119060021VH150939CY, H41212ZD), VH1… (truncated, 96433 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH161002TY (01008406821216511117092521VH161002TY, H41212RL), VH161494JD (01008406821216511118011021VH161494JD, H41212RL), VH161911LV (01008406821216511118030021VH161911LV, H41212RL), VH163440GG (01008406821216511118121421VH163440GG, H41212YZ), VH261421ZS (01008406821216511120040021VH261421ZS, H41212YZ), VH162444U2 (01008406821216511118060021VH162444U2, H41212YZ), VH165272MV (01008406821216511119070021VH165272MV, H41212YZ), VH264483KQ (01008406821216511121011921VH264483KQ, H41212YZ), VH261426TR (01008406821216511120040021VH261426TR, H41212YZ), VH260601DD (01008406821216511120030021VH260601DD, H41212YZ), VH260693VL (01008406821216511120030021VH260693VL, H41212YZ), VH261300BX (01008406821216511120030021VH261300BX, H41212YZ), VH262303C1 (01008406821216511120061021VH262303C1, H41212YZ), VH1650459M (01008406821216511119060021VH1650459M, H41212YZ), VH26015148 (01008406821216511119120021VH26015148, H41212YZ), VH260359ZY (01008406821216511120030021VH260359ZY, H41212YZ), VH2605125L (01008406821216511120030021VH2605125L, H41212YZ), VH1617429V (01008406821216511118050021VH1617429V, H41212YZ), VH161794AP (01008406821216511118020021VH161794AP, H41212RL), VH165044C8 (01008406821216511119120021VH165044C8, H41212YZ), VH160828M8 (01008406821216511117080021VH160828M8, H41212RL), VH26143341 (01008406821216511120040021VH26143341, H41212YZ), VH264734WW (01008406821216511121020921VH264734WW, H41212YZ), VH163182CD (01008406821216511118090021VH163182CD, H41212YZ), VH265179EX (01008406821216511121040621VH265179EX, H41212YZ), VH163884HV (01008406821216511119031121VH163884HV, H41212YZ), VH260371WV (01008406821216511119120021VH260371WV, H41212YZ), VH260413XV (01008406821216511119120021VH260413XV, H41212YZ), VH261844IZ (01008406821216511120050521VH261844IZ, H41212YZ), VH1634495A (01008406821216511118110021VH1634495A, H41212YZ), VH265859FV (01008406821216511121071221VH265859FV, H41212YZ), VH266211S7 (01008406821216511121090821VH266211S7, H41212YZ), VH260422R5 (01008406821216511119120021VH260422R5, H41212YZ), VH261855IA (01008406821216511120050521VH261855IA, H41212YZ), VH262511X9 (01008406821216511120062521VH262511X9, H41212YZ), VH162672ZZ (01008406821216511118070021VH162672ZZ, H41212YZ), VH2603199C (01008406821216511120030021VH2603199C, H41212YZ), VH261392QA (01008406821216511120040021VH261392QA, H41212YZ), VH2614246U (01008406821216511120040021VH2614246U, H41212YZ), VH264744WA (01008406821216511121020521VH264744WA, H41212YZ), VH163373TQ (01008406821216511118110021VH163373TQ, H41212YZ), VH161230QP (01008406821216511117110021VH161230QP, H41212RL), VH163520B5 (01008406821216511118120021VH163520B5, H41212YZ), VH163543XL (01008406821216511118120021VH163543XL, H41212YZ), VH260572RJ (01008406821216511120030021VH260572RJ, H41212YZ), VH261820EA (01008406821216511120050521VH261820EA, H41212YZ), VH261451K8 (01008406821216511120040021VH261451K8, H41212YZ), VH261467NC (01008406821216511120040021VH261467NC, H41212YZ), VH261556JT (01008406821216511120040021VH261556JT, H41212YZ), VH1635644D (01008406821216511118120021VH1635644D, H41212YZ), VH163574GX (01008406821216511118120021VH163574GX, H41212YZ), VH163602RD (01008406821216511118120021VH163602RD, H41212YZ), VH165182SZ (01008406821216511119090021VH165182SZ, H41212YZ), VH165549SD (01008406821216511119090021VH165549SD, H41212YZ), VH1635656M (01008406821216511118120021VH1635656M, H41212YZ), VH2610751I (01008406821216511120040021VH2610751I, H41212YZ), VH261332S1 (01008406821216511120040021VH261332S1, H41212YZ), VH265083NK (01008406821216511121040621VH265083NK, H41212YZ), VH265941H1 (01008406821216511121071521VH265941H1, H41212YZ), VH162698PH (01008406821216511118070021VH162698PH, H41212YZ), VH16276523 (01008406821216511118070021VH16276523, H41212YZ), VH261336EQ (01008406821216511120040021VH261336EQ, H41212YZ), VH261388BN (01008406821216511120040021VH261388BN, H41212YZ), VH264603D7 (01008406821216511121020521VH264603D7, H41212YZ), VH262582C9 (01008406821216511120062921VH262582C9, H41212YZ), VH2625993T (01008406821216511120062521VH2625993T, H41212YZ), VH1614977P (01008406821216511118010021VH1614977P, H41212RL), VH161800BC (01008406821216511118020021VH161800BC, H41212RL), VH261513Z4 (01008406821216511120040021VH261513Z4, H41212YZ), VH162215VB (01008406821216511118050021VH162215VB, H41212YZ), VH165048BU (01008406821216511119060021VH165048BU, H41212YZ), VH2638216Q (01008406821216511120121421VH2638216Q, H41212YZ), VH2640834X (01008406821216511120121021VH2640834X, H41212YZ), VH2640875J (01008406821216511120121021VH2640875J, H41212YZ), VH264109NY (01008406821216511120121021VH264109NY, H41212YZ), VH264213B3 (01008406821216511120121421VH264213B3, H41212YZ), VH2642289A (01008406821216511120121421VH2642289A, H41212YZ), VH265978R2 (01008406821216511121080321VH265978R2, H41212YZ), VH266059Z5 (01008406821216511121080321VH266059Z5, H41212YZ), VH266118PA (01008406821216511121081921VH266118PA, H41212YZ), VH266145GN (01008406821216511121081921VH266145GN, H41212YZ), VH2… (truncated, 72034 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 4, 2021

GE Vscan Extend, being sold as "Vscan Extend Console"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89102
Lot/product code:
Information reads "Serial Number (UDI, Model Number)". VH1622261Y (01008406821216511118042621VH1622261Y, 5693455), VH161664XA (01008406821216511118031921VH161664XA, 5693455), VH2627194S (01008406821216511120071321VH2627194S, 5693455), VH160129E8 (01008406821216511117021721VH160129E8, 5693455), VH160834YQ (01008406821216511117110021VH160834YQ, 5693455), VH1642124F (01008406821216511119040921VH1642124F, 5693455), VH150152W7 (01008406821216511116080021VH150152W7, 5693455), VH160113JQ (01008406821216511117020321VH160113JQ, 5693455), VH161979EY (01008406821216511118030021VH161979EY, 5693455), VH162446PC (01008406821216511118061221VH162446PC, 5693455), VH161984GS (01008406821216511118030021VH161984GS, 5693455), VH161970GQ (01008406821216511118030021VH161970G, 5693455), VH1619899S (01008406821216511118030021VH1619899S, 5693455), VH160237FQ (01008406821216511117030021VH160237FQ, 5693455), VH1600005U (5693455), VH160007CX (5693455), VH160009UF (5693455), VH150153FK (5693455), VH161672SF (5693455), VH1624281N (5693455), VH150103AI (5693455), VH150150Z6 (5693455), VH160786JM (5693455), VH1608086P (5693455), VH1600107T (5693455), VH1607384V (5693455), VH1600112G (5693455), VH160012JB (5693455), VH1607406X (5693455), VH160742EX (5693455), VH1608215J (5693455), VH160633NC (5693455), VH160025HU (5693455), VH160744ZM (5693455), VH150151QA (5693455), VH160730NB (5693455), VH161629J2 (5693455), VH161631UU (5693455), VH160735W7 (5693455), VH161598QQ (5693455), VH1600189D (5693455), VH1501544T (5693455), VH160017E2 (5693455), VH150123AH (5693455), VH163240NI (5693455), VH160005HB (5693455), VH1656702Z (5693455), VH16567191 (5693455), VH1656729W (5693455), VH1656736Y (5693455), VH165674RL (5693455), VH165675AQ (5693455), VH165676D7 (5693455), VH1656777R (5693455), VH165678YC (5693455), VH165679H1 (5693455), VH150112VD (5693455), VH150113IF (5693455), VH1607343V (5693455), VH160012JB (5693455), VH150101S2 (5693455), VH160001S1 (5693455), VH160003N9 (5693455), VH1616079K (5693455), VH150105RI (5693455), VH150118BJ (5693455), VH1501144B (5693455), VH150119KV (5693455), VH150122PV (5693455), VH150104JE (5693455), VH150067PS (5693455), VH150102JE (5693455), VH16162756 (5693455), VH260391G7 (5693455), VH2609418F (5693455), VH26096618 (5693455), VH1600301G (5693455), VH160021FJ (5693455), VH160163HW (5693455)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 9, 2021

Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.

A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.

AZCAFLILINKSKYMIMNMOMSNENVOHOKORSCTXUTVAWA
▸Full report

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

Recall #:
89074
Lot/product code:
All lot numbers
Recalling firm:
Medtronic Navigation, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 10, 2021

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.

ALL 50 STATES
▸Full report

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

Recall #:
89035
Lot/product code:
Lot: M106450, UDI: 15099590575113
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 11, 2021

Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585

Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury.

AKALARAZCACOCTDCDEFLGAGUHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRSCSDTNTXUTVAWAWIWVWY
▸Full report

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

Recall #:
89058
Lot/product code:
9733763, Version: 2.2.8; 9735585, Versions: 3.1.1, 3.1.2, 3.1.3
Recalling firm:
Medtronic Navigation, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2021

TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z

Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.

ALAZCACOCTFLGAHIIAIDILINKYLAMAMDMIMNMOMSNCNENHNJNVNYOHOKORPASCSDTNTXUTVAWIWVWY
▸Full report

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

Recall #:
89170
Lot/product code:
0-Degree Lots: 1903120, 1903250, 1904060, 1904180, 1904240, 1905030, 1905070, 1906260, 1907120, 1907170, 1907220, 1907240, 1907260, 2003040, 2009110, 2011240, 2102080, 2103090, 2104260, 2105040, 2105260, 2106100, 2107070. 70-Degree Lots: 1903137, 1903257, 1904067, 1905017, 1905037, 1905077, 1906067, 1906267, 1907127, 1908137, 1908157, 2003127. 90-Degree: 1903139, 1903259, 1904069, 1905019, 1905139, 1906079, 1908269, 1909279, 1909309, 1910299, 2003029, 2004029
Recalling firm:
Acclarent, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2021

Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA

Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit

ALL 50 STATES
▸Full report

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

Recall #:
89024
Lot/product code:
Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2021

Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C

Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury

ALL 50 STATES
▸Full report

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

Recall #:
89062
Lot/product code:
LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: IFX-20C 00841447111627 IFX-20MP 00841447111658 IFX-20R 00841447111634 IFX-20SP 00841447111641 IFX20WIDE 00841447111658
Recalling firm:
Invacare Corporation
View official FDA record (opens in a new tab)