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Recalls affecting Arizona

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

16,969 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

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

View FDA’s announcement (opens in a new tab)
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

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

View FDA’s announcement (opens in a new tab)
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

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

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: 50885380172500 (cs) 10885380172502 (ea)
Recalling firm:
Cardinal Health
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2021

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.

ALL 50 STATES
▸Full report

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

Recall #:
88981
Lot/product code:
All serial numbers. UDI: 04953170339967
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
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

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

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

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

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

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 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 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

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

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 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

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 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 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

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

ALL 50 STATES
▸Full report

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

Recall #:
89129
Lot/product code:
serial Numbers: 2368 257 252 1234 1139 1989 12662 604 1858 4196 2046 1826 312 313 1360 2438 802 844 1620 3007 2348 318 303 2737 2739 1197 2564 983 236 481 1983 386 13027 74 75 589 693 154 2735 13242 377 798 4466 687 77 565 1101 112 2836 2837 1703 13006 13014 2427 12954 1982 4740 13796 13795 561 13823 13824 597 671 1089 113 1732 13156 1866 2423 1427 325 108 3721 3189 326 3093 603 622 924 282 1984 1152 3009 1059 1136 981 2342 2666 196 73 1650 793 794 799 800 444 3857 289 2866 2020 1138 1547 1548 2708 13604 415 548 3186 2409 2760 3485 3487 2012 48 1869 50 927 193 351 383 384 2811 2821 1885 12566 1937 2365 2810 3078 12618 12619 12620 12621 12622 12623 12624 12625 12626 12628 4080 13051 3534 3301 2279 2385 194 609 52 2185 2311 2366 2177 1461 488 489 492 13519 3568 4758 4759 130 398 3760 2978 3594 1609 1709 2284 4475 285 4390 740 485 2430 38 635 1938 117 13810 3513 13 951 13456 12495 1140 2095 639 1990 2300 1448 897 577 1820 378 259 4381 1744 1745 1746 3512 505 2707 2888 2706 40 1575 2644 2281 1378 2807 1376 12692 1956 535 12895 1148 1987 570 641 366 1438 2526 177 15 2397 1986 3516 2606 644 1734 1735 381 3103 102 514 1085 2003 13402 30 278 1030 1831 139 1586 1567 431 1478 402 806 3058 3962 3963 2266 2227 13326 4022 1487 2338 4094 306 4380 1608 152 12678 3079 591 13394 35 2411 550 2915 1818 121 2704 13072 1048 4320 1677 4137 103 104 111 3190 987 988 2679 64 2410 182 227 2216 92 484 475 1660 1291 58 2465 2843 82 424 2111 13634 2126 1463 2194 2897 2898 2899 2900 2901 1981 1474 2424 1488 1736 1537 2075 3005 437 1797 2819 2437 2822 2431 3632 13312 3495 655 719 33 54 304 307 309 12651 652 879 933 1509 1079 1741 1742 1726 1727 3527 1037 2436 2926 2927 12778 893 2336 886 2282 810 1417 1201 1558 2444 2485 744 273 1049 1424 2667 2668 2169 68 3195 645 62 545 12744 219 2280 766 13381 69 70 623 657 1185 3451 619 1055 213 792 590 12529 12706 684 1470 389 551 1783 3273 3274 1018 3128 564 242 243 938 504 513 1067 3199 411 61 352 12966 1455 926 2025 2617 4077 4772 263 264 265 266 267 268 269 270 271 272 441 3761 56 739 2473 3381 694 809 625 324 1038 13714 13717 2736 1497 867 12701 76 13214 12579 901 1161 2418 2525 612 1361 1363 2448 677 479 405 818 4778 1968 2570 2575 12548 42 1606 1607 1967 2341 3519 3520 3557 4742 4757 2016 669 3469 1221 293 3514 292 471 287 1647 1574 1026 1027 1028 109 2571 2572 365 1743 12707 1529 2203 3539 1340 2120 2121 1135 12474 13398 13116 1657 1091 3442 13071 1192 2559 2786 508 1471 1634 539 4470 291 1147 13581 12642 470 32 211 89 90 2432 895 2441 1506 200 1131 1476 13112 12429 971 2527 12567 12859 13007 2118 2119 2565 2860 986 1663 782 2022 3213 3196 72 418 2168 1865 3086 795 2183 2064 1496 1102 796 797 1422 3209 4090 4091 4092 1472 3730 2561 2931 1256 2440 1648 1483 2566 244 245 246 875 235 13062 2562 1029 541 256 1259 1615 1872 2358 2834 115 3101 3090 4615 464 465 990 804 349 1477 1479 201 238 41 1416 3504 1966 825 878 2916 2611 1946 1597 2097 3238 2135 1848 480 1546 3191 3731 12702 13636 12987 447 2635 2636 100 191 1041 1132 2187 159 741 923 977 4391 826 1527 2832 3517 374 3370 3375 1480 3327 4613 4614 223 44 3411 3092 1991 13243 2923 221 12953 440 31 691 726 392 2919 529 1536 26 718 13307 2689 4103 3515 824 391 1898 582 820 1903 210 116 747 887 1033 1065 646 49 3855 1523 1999 1998 4373 2000 991 1250 2744 1356 2246 4423 4424 1731 2455 91 379 320 311 2277 3319 12801 2477 251 1130 1988 1588 1589 1590 616 1572 209 640 99 34 39 801 3968 1635 1979 43 2863 654 13829 66 3664 1827 2429 3184 414 605 663 664 665 413 662 13505 647 1429 769 2484 542 543 4227 1323 1970 357 358 3210 2865 1965 1220 416 1992 1475 408 1857 348 982 1819 319 2958 3134 12501 2099 3392 37 12900 178 3069 1032 1305 1894 403 1141 1142 3076 4751 4756 3109 1530 1868 1423 4569 13209 2818 12603 4727 4728 4729 4730 2702 4078 1980 928 929 930 931 932 2703 12975 1362 2349 2350 902 3088 1528 249 2612 487 1058 13665 13628 2820 1921 827 686 2042 1226 1306 1659 1661 3856 626 627 2766 2767 660 29 12969 12790 13549 2844 3424 13462 1364 2993 2994 65 2823 2043 1390 2713 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2433 … (truncated, 37704 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)