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Recalls affecting Tennessee

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

17,086 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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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

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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

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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.

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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.

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UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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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.

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UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

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

Recall #:
88826
Lot/product code:
Lot Numbers 6032947 and 6033588 UDI: " Primary: 00886158019961 " Secondary: 30886158019962 " Tertiary: 50886158019966
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 11, 2021

Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)

Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property

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

Recall #:
89134
Lot/product code:
All units
Recalling firm:
Forbes Rehab Services Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 12, 2021

Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7); 11. CUSTOM PACK BB8B09R8 INFANT (Model BB8B09R8); 12. CUSTOM PACK BB8D40R3 P3/16X1/4 (Model BB8D40R3); 13. CUSTOM PACK BB8Q16R PED ART (Model BB8Q16R); 14. CUSTOM PACK BB8V01R8 FVDL COLM (Model BB8V01R8); 15. CUSTOM PACK HY2V10R33 ADULT (Model HY2V10R33); 16. CUSTOM PACK HY3Z71R17 PRIMARY (Model HY3Z71R17); 17. CUSTOM PACK HY3Z71R18 PRIMARY (Model HY3Z71R18); 18. CUSTOM PACK HY4V00R24 ADULT (Model HY4V00R24); 19. CUSTOM PACK HY6X29R12 CON-SUPP (Model HY6X29R12); 20. CUSTOM PACK HY8L14R7 HYBRID (Model HY8L14R7); 21. CUSTOM PACK HY8P36R6 CPS (Model HY8P36R6); 22. CUSTOM PACK HY8V01R6 FVDL COLM (Model HY8V01R6); 23. CUSTOM PACK HY9D36R1 HL PUMP P (Model HY9D36R1); 24. CUSTOM PACK HY9L07R4 ADLT FUS (Model HY9L07R4); 25. CUSTOM PACK HY9L80R4 SADT FUS (Model HY9L80R4); 26. CUSTOM PACK HY9M47R6 ADLT MAIN (Model HY9M47R6); 27. CUSTOM PACK HY9N38R4 VGH FUS (Model HY9N38R4); 28. CUSTOM PACK HY9R26R12 CENT (Model HY9R26R12); 29. PERFUSION M337112Q 1/B (Model M337112Q); 30. PERFUSION M344130B 1/B (Model M344130B); 31. PERFUSION M392419C 1/B (Model M392419C); 32. PERFUSION M394213B 1/B (Model M394213B); 33. PERFUSION M394213C 1/B (Model M394213C); 34. PERFUSION M490124D 1/B (Model M490124D); 35. PERFUSION M491335A 1/B (Model M491335A); 36. PERFUSION M499709E 1/B (Model M499709E); 37. PERFUSION M960164F 1/B (Model M960164F); 38. PERFUSION M960165E 1/B (Model M960165E); 39. PERFUSION M960169E 1/B (Model M960169E); 40. PERFUSION M960462C 1/B (Model M960462C); 41. PERFUSION M960462D 1/B (Model M960462D); 42. PERFUSION M960463D 1/B (Model M960463D); 43. PERFUSION M960466D 1/B (Model M960466D); 44. CUSTOM PACK TL4K33R3 FCI ADULT (Model TL4K33R3); 45. CUSTOM PACK TL4K95R12 PERFNPLEG (Model TL4K95R12); 46. CUSTOM PACK TL6C91R5 SELLKE PK (Model TL6C91R5); 47. CUSTOM PACK TL6G48R9 ST PAULS (Model TL6G48R9); 48. CUSTOM PACK TL7X09R3 FCVC ADLT (Model TL7X09R3);

Product is labeled as non-pyrogenic but endotoxin testing was not performed.

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

Recall #:
88932
Lot/product code:
Medtronic Perfusion Kits: 1. Model BB10Q85R, (a) GTIN 00763000343057, Lot Numbers: 219164410, 220219784, 220822136, 222227252; (b) GTIN 20763000343068, Lot Numbers: 219822381, 220104257 2. Model BB11C01R, GTIN 00763000312190, Lot Numbers: 218556144, 218790882, 219012584, 219586019 3. Model B7H95R22, GTIN 00763000250904, Lot Numbers: 219586008, 220075503, 220476338 4. Model BB7H95R25, GTIN 00763000451738, Lot Numbers: 221406421 5. Model BB7H99R22, GTIN 00763000250911, Lot Numbers: 219814395, 219886115, 220143946, 220257643, 220434398 6. Model BB7P46R4, GTIN 00643169380967, Lot Numbers: 218503747, 219975261, 220383910, 221017404, 221148797 7. Model BB7P48R4, GTIN 00643169379848, Lot Numbers: 219073386 8. Model BB7W03R8, GTIN 00643169990562, Lot Numbers: 219107651, 219491297, 221590546 9. Model BB7W80R7, GTIN 00763000344535, Lot Numbers: 219380830, 219600017, 222304697, 222400044 10. Model BB8B09R7, GTIN 00763000307189, Lot Numbers: 218613111 11. Model BB8B09R8, GTIN 00763000347574, Lot Numbers: 219291877, 219529760, 219663957, 220095395, 220476333, 221148863, 221765951, 222227240, 222469109 12. Model BB8D40R3, GTIN 00643169655461, Lot Numbers: 219220652, 219482298 13. Model BB8Q16R, GTIN 00643169549364, Lot Numbers: 218657286, 221451556 14. Model BB8V01R8, GTIN 00763000411312, Lot Numbers: 221267645 15. Model HY2V10R33, GTIN 00763000299835, Lot Numbers: 219165752, 220104314 16. Model HY3Z71R17, GTIN 00763000241551, Lot Numbers: 219073460 17. Model HY3Z71R18, GTIN 00763000353728, Lot Numbers: 219435852, 220219913, 220911962 18. Model HY4V00R24, GTIN 00763000082451, Lot Numbers: 219115980, 219436006, 219975242, 220383867 19. Model HY6X29R12, GTIN 00763000280833, Lot Numbers: 218912023, 219061258, 219061259, 219061260, 219390708, 220075525, 220075526, 220281424, 220434431 20. Model HY8L14R7, GTIN 00763000353360, Lot Numbers: 220075494 21. Model HY8P36R6, GTIN 00763000097165. Lot Numbers: 219291532 22. Model HY8V01R6, GTIN 00763000025465, Lot Numbers: 218557263, 218901885 23. Model HY9D36R1, GTIN 00643169855465, Lot Numbers: 219291881, 219291882, 219291883, 219682010, 220144062, 220144063, 220383952, 220383953, 220383954 24. Model HY9L07R4, GTIN 00763000093495, Lot Numbers: 219237962 25. Model HY9L80R4, GTIN 00763000092603, Lot Numbers: 220104289 26. Model HY9M47R6, GTIN 00763000175634, Lot Numbers: 219165837, 219165838, 219452417, 219452418, 220295056, 220295059 27. Model HY9N38R4, GTIN 00643169985148, Lot Numbers: 219061189, 219390629, 220383876, 220954138 28. Model HY9R26R12, GTIN 00763000317942, Lot Numbers: 218790663, 219343932, 219401495, 220337254, 220866450, 220866451 29. Model M337112Q, GTIN 00763000242824, Lot Numbers: 219983643, 219984266, 221053657, 221206757, 221452447, 221516971 30. Model M344130B, GTIN 00643169946415, Lot Numbers: 218419494, 218419495, 220815603, 220883905, 221971754 31. Model M392419C, GTIN 00763000343095, Lot Numbers: 219179139, 220224289, 220637117, 221383886 32. Model M394213B, GTIN 00643169546417, Lot Numbers: 218544365, 218544407 33. Model M394213C, GTIN 00763000446437, Lot Numbers: 221309293, 222084799 34. Model M490124D, GTIN 00763000527471, Lot Numbers: 222060635 35. Model M491335A, GTIN 00763000372187, Lot Numbers: 219712665, 220479358 36. Model M499709E, GTIN 00643169713420, Lot Numbers: 219495811 37. Model M960164F, GTIN 00763000300128, Lot Numbers: 218616224, 218616225, 219868444, 22280711 38. Model M960165E, GTIN 00763000139445, Lot Numbers: 218551983, 218728458, 218728459, 222107381 39. Model M960169E, GTIN 00763000139421, Lot Numbers: 218517966, 220900240, 222047414, 222410763 40. Model M960462C, GTIN 00643169957015, Lot Numbers: 218953465 41. Model M960462D, GTIN 00763000399344, Lot Numbers: 220172291 42. Model M960463D, GTIN 00763000234775. Lot Numbers: 218483662, 218517778, 218742946, 218742949, 220729353, 220801827, 220867180, 220950181, 221143520, 221618074, 221875985 43. Model M960466D, GTIN 00763000090494, Lot Numbers: 219874178 44. Model TL4K33R3, GTIN 00613994288622, Lot Numbers: 220197637 45. Model TL4K95R12, GTIN 00763000247867, Lot Numbers: 219061229, 220383926 46. Model TL6C91R5, GTIN 00643169343641, Lot Numbers: 219435870 47. Model TL6G48R9, GTIN 00763000367909, Lot Numbers: 220004241, 220004242, 220326313, 220911952, 220911998 48. Model TL7X09R3, GTIN 00643169455115, Lot Numbers: 219107641, 219107642, 221000547
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 12, 2021

Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF; Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1. Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1.

The processing of collected episode data may fail due to a software error.

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

Recall #:
88907
Lot/product code:
Application software lower than v5.0.0.
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled October 12, 2021

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0092-2022
Lot/product code:
Lot #: 163935, Exp: 10/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 13, 2021

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

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

Recall #:
88930
Lot/product code:
Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 13, 2021

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.

Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

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

Recall #:
89104
Lot/product code:
RPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615
Recalling firm:
Cook Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual

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

Recall #:
88849
Lot/product code:
Serial Numbers/UDI: G3024453 (01)04562122959278(11)191029(21)G3024453 G3024456 (01)04562122959278(11)191029(21)G3024456 G3042466 (01)04562122959278(11)191115(21)G3042466 G3042471 (01)04562122959278(11)191115(21)G3042471 G3042477 (01)04562122959278(11)191115(21)G3042477 G3042478 (01)04562122959278(11)191115(21)G3042478 G3042484 (01)04562122959278(11)191115(21)G3042484 G3042486 (01)04562122959278(11)191115(21)G3042486 G3042487 (01)04562122959278(11)191115(21)G3042487 G3042496 (01)04562122959278(11)191115(21)G3042496 G3042499 (01)04562122959278(11)191115(21)G3042499 G3042501 (01)04562122959278(11)191115(21)G3042501 G3042576 (01)04562122959278(11)191220(21)G3042576 G3042578 (01)04562122959278(11)191220(21)G3042578 G3042583 (01)04562122959278(11)191220(21)G3042583 G3042584 (01)04562122959278(11)191205(21)G3042584 G3042585 (01)04562122959278(11)191205(21)G3042585 G3042587 (01)04562122959278(11)191205(21)G3042587 G3042588 (01)04562122959278(11)191220(21)G3042588 G3082956 (01)04562122959278(11)200929(21)G3082956 G3085640 (01)04562122959278(11)200929(21)G3085640 G3085644 (01)04562122959278(11)200929(21)G3085644 G3095193 (01)04562122959278(11)201211(21)G3095193 G3095194 (01)04562122959278(11)201211(21)G3095194 G3095195 (01)04562122959278(11)201211(21)G3095195 G3095197 (01)04562122959278(11)201211(21)G3095197 G3095202 (01)04562122959278(11)201211(21)G3095202 G3095445 (01)04562122959278(11)201228(21)G3095445 G3111596 (01)04562122959278(11)210401(21)G3111596 G3111597 (01)04562122959278(11)210401(21)G3111597 G3111598 (01)04562122959278(11)210401(21)G3111598 G3111605 (01)04562122959278(11)210402(21)G3111605 G3111606 (01)04562122959278(11)210402(21)G3111606 G3114264 (01)04562122959278(11)210428(21)G3114264 G3114267 (01)04562122959278(11)210428(21)G3114267 G3114366 (01)04562122959278(11)210514(21)G3114366 G3114368 (01)04562122959278(11)210514(21)G3114368 G3114372 (01)04562122959278(11)210517(21)G3114372 G3114373 (01)04562122959278(11)210517(21)G3114373 G3114376 (01)04562122959278(11)210517(21)G3114376 G3114379 (01)04562122959278(11)210517(21)G3114379 G3114399 (01)04562122959278(11)210518(21)G3114399 G3114897 (01)04562122959278(11)210519(21)G3114897 G3114902 (01)04562122959278(11)210519(21)G3114902 G3118967 (01)04562122959278(11)210528(21)G3118967 G3118968 (01)04562122959278(11)210528(21)G3118968
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

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

Recall #:
88840
Lot/product code:
Serial Numbers/UDI: 20514657 (01)04562122958868(11)161220(21)20514657; 20659147 (01)04562122958868(11)20181124(21)20659147; 20659148 (01)04562122958868(11)20181124(21)20659148; 20659149 (01)04562122958868(11)20181124(21)20659149; 20659150 (01)04562122958868(11)20181124(21)20659150; 20659153 (01)04562122958868(11)20181126(21)20659153; 20659154 (01)04562122958868(11)20181126(21)20659154; 20659155 (01)04562122958868(11)20181126(21)20659155; 20659156 (01)04562122958868(11)20181126(21)20659156; 205G0225 (01)04562122958868(11)20170418(21)205G0225; 205G0226 (01)04562122958868(11)20170424(21)205G0226; 205P2146 (01)04562122958868(11)20170615(21)205P2146; 205P2147 (01)04562122958868(11)20170615(21)205P2147; 205P2148 (01)04562122958868(11)20170615(21)205P2148; 205P2149 (01)04562122958868(11)20170615(21)205P2149; 205Q0809 (01)04562122958868(11)20170707(21)205Q0809; 205Q0810 (01)04562122958868(11)20170707(21)205Q0810; 205Q0812 (01)04562122958868(11)20170707(21)205Q0812; 205Q0815 (01)04562122958868(11)20171006(21)205Q0815; 205T7139 (01)04562122958868(11)20171006(21)205T7139; 205T7143 (01)04562122958868(11)20171026(21)205T7143; 205V5544 (01)04562122958868(11)20171026(21)205V5544; 205V5545 (01)04562122958868(11)20171030(21)205V5545; 205V5547 (01)04562122958868(11)20171031(21)205V5547; 205V5548 (01)04562122958868(11)20171031(21)205V5548; G3005239 (01)04562122958868(11)20190308(21)G3005239; G3005240 (01)04562122958868(11)20190308(21)G3005240; G3025041 (01)04562122958868(11)20190603(21)G3025041; G3025042 (01)04562122958868(11)20190604(21)G3025042; G3025044 (01)04562122958868(11)20190605(21)G3025044; G3025045 (01)04562122958868(11)20190605(21)G3025045; G3025048 (01)04562122958868(11)20190606(21)G3025048; G3025049 (01)04562122958868(11)20190606(21)G3025049; G3037183 (01)04562122958868(11)20190624(21)G3037183; G3037184 (01)04562122958868(11)20190624(21)G3037184; G3037192 (01)04562122958868(11)20190709(21)G3037192; G3043580 (01)04562122958868(11)20190820(21)G3043580; G3043581 (01)04562122958868(11)20190820(21)G3043581; G3043582 (01)04562122958868(11)20190820(21)G3043582; G3052217 (01)04562122958868(11)20191016(21)G3052217; G3052218 (01)04562122958868(11)20191016(21)G3052218; G3052225 (01)04562122958868(11)20191202(21)G3052225; G3052234 (01)04562122958868(11)20200128(21)G3052234; G3052236 (01)04562122958868(11)20200109(21)G3052236; G3054831 (01)04562122958868(11)20200115(21)G3054831; G3054833 (01)04562122958868(11)20191212(21)G3054833; G3054840 (01)04562122958868(11)20200115(21)G3054840; G3080616 (01)04562122958868(11)20201215(21)G3080616; G3080617 (01)04562122958868(11)20201215(21)G3080617; G3106256 (01)04562122958868(11)20210413(21)G3106256; G3106258 (01)04562122958868(11)20210413(21)G3106258; G3111572 (01)04562122958868(11)20210413(21)G3111572; G3111573 (01)04562122958868(11)20210421(21)G3111573
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

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

Recall #:
93651
Lot/product code:
Model 712001 - UDI-DI 00884838028586, all serial numbers; Model 712002 - UDI-DI 00884838082373, all serial numbers; Model 712004 - UDI-DI 08436046002173, all serial numbers; Model 712006 - UDI-DI 00884838091504, serial numbers: SN20410556 and SN21410184; Model 712007 - UDI-DI)08436046002357, serial numbers: 26, 27, 19410038, 19410044, 19410046, 21410261, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410339, 21410340, 21410341, 21410342, 21410345, 22410022, 22410023, SN0410157, SN1410049, SN19410034, SN19410035, SN19410036, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410129, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, SN20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410555, SN20410556, SN20410557, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410094, SN21410099, SN21410103, SN21410104, SN21410105, SN21410117, SN21410118, SN21410119, SN21410130, SN21410131, SN21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, SN21410213, SN21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, and SNZY204110015.
Recalling firm:
SEDECAL SA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

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▸Full report

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

Recall #:
88840
Lot/product code:
Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G3108401; G3114959 (01)04562122959841(11)210524(21)G3114959
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

ALL 50 STATES
▸Full report

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

Recall #:
88840
Lot/product code:
Serial Numbers: 205W3386 (01)04562122958974(11)171114(21)205W3386; 206F7900 (01)04562122958974(11)180926(21)206F7900; 206F7901 (01)04562122958974(11)180926(21)206F7901; 206F7936 (01)04562122958974(11)181113(21)206F7936; 206F7937 (01)04562122958974(11)181113(21)206F7937; 206F7940 (01)04562122958974(11)181113(21)206F7940; 206F7941 (01)04562122958974(11)181113(21)206F7941; 206F7942 (01)04562122958974(11)181113(21)206F7942; 206F7944 (01)04562122958974(11)181113(21)206F7944; 206F7945 (01)04562122958974(11)181113(21)206F7945; 206F7946 (01)04562122958974(11)181113(21)206F7946; 206F7947 (01)04562122958974(11)181114(21)206F7947; G3002552 (01)04562122958974(11)20190115(21)G3002552; G3024545 (01)04562122958974(11)190607(21)G3024545; G3037885 (01)04562122958974(11)20190719(21)G3037885; G3037887 (01)04562122958974(11)20190719(21)G3037887; G3042405 (01)04562122958974(11)190829(21)G3042405; G3042823 (01)04562122958974(11)20190807(21)G3042823; G3042828 (01)04562122958974(11)20190808(21)G3042828; G3045094 (01)04562122958974(11)20190822(21)G3045094; G3052105 (01)04562122958974(11)20191008(21)G3052105 G3052118 (01)04562122958974(11)20191025(21)G3052118 G3055549 (01)04562122958974(11)20191118(21)G3055549 G3055550 (01)04562122958974(11)20191118(21)G3055550 G3055552 (01)04562122958974(11)20191118(21)G3055552 G3055553 (01)04562122958974(11)20191118(21)G3055553 G3055554 (01)04562122958974(11)20191118(21)G3055554 G3055555 (01)04562122958974(11)20191118(21)G3055555 G3060234 (01)04562122958974(11)20191206(21)G3060234 G3060254 (01)04562122958974(11)20191206(21)G3060254 G3060275 (01)04562122958974(11)20191216(21)G3060275 G3060278 (01)04562122958974(11)20191216(21)G3060278 G3060690 (01)04562122958974(11)200127(21)G3060690 G3071074 (01)04562122958974(11)20200227(21)G3071074 G3080785 (01)04562122958974(11)201105(21)G3080785 G3090450 (01)04562122958974(11)201225(21)G3090450 G3110884 (01)04562122958974(11)210401(21)G3110884
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETBF2313C166EE STENT GRAFT ETBF2313C166EE ENDUR II BIF ETBF2513C124EE STENT GRAFT ETBF2513C124EE ENDUR II BIF ET

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

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▸Full report

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

Recall #:
88951
Lot/product code:
Model Number/GTIN Code/Product Description: ETBF2513C145EE 00643169781047 V30584649 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593589 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593590 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593591 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593592 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593593 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593594 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593595 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE 00643169780798 V30595328 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE 00643169780798 V30595331 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE 00643169780798 V30595332 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE 00643169780934 V30595382 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595383 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595386 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595389 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595390 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595391 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE 00643169780972 V30595456 STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595505 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595515 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595516 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595517 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596585 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596586 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596587 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596625 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596626 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596634 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596635 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596637 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596639 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596640 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596641 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596644 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596645 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596646 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596648 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596649 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596650 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596651 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596655 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603296 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603298 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603309 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603310 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603311 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603312 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603313 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603315 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E 00643169232570 V30608080 STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE 00643169780897 V30609554 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609556 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609557 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609558 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609559 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609560 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609561 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609564 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E 00613994991430 V30616355 STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616364 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616365 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616368 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E 00… (truncated, 33700 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

GE Centricity Universal Viewer Zero Footprint Client

There is a potential to display incomplete patient imaging study.

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▸Full report

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

Recall #:
88959
Lot/product code:
Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988.
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF231

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

ALL 50 STATES
▸Full report

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

Recall #:
88951
Lot/product code:
Model Number/GTIN Code/Product Description: ESBF2814C103EE 00643169780446 V30609409 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609410 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609411 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609412 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609415 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609417 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609420 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609421 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609423 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616743 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616746 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616748 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E 00643169439993 V30618898 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618899 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618902 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30618963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618964 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618965 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618966 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618967 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618968 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618969 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618970 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618971 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618972 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618973 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618974 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618975 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618976 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618977 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618978 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618979 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618980 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618982 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618983 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618984 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618988 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618989 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE 00763000098858 V30619120 STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619159 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619161 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625915 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625916 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625917 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625918 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625921 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625935 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625936 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625938 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625941 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625942 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625943 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625944 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625945 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625946 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625947 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625948 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625949 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625950 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625951 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625952 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643… (truncated, 12383 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

ALL 50 STATES
▸Full report

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

Recall #:
88951
Lot/product code:
Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS); 39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS); 39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM); 39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE); 39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE); 39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE); 39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE); 39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM); 39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES); 39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES); 39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES)

To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.

AKALARAZCACOCTDCDEFLGAGUHIIAIDILINKSKYLAMAMDMEMIMNMOMPMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVIVTWAWIWVWY
▸Full report

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

Recall #:
88998
Lot/product code:
All lots with Instructions for Use Prior to PI-000078-10.0 (06/21)
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 19, 2021

Model B35200 - Percept PC BrainSense Implantable Neurostimulator

During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

ALL 50 STATES
▸Full report

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

Recall #:
88889
Lot/product code:
GTIN 00763000253363, Serial Numbers: NPI714835H, NPI714811H, NPI714812H, NPI714814H, NPI714816H, NPI714817H, NPI714819H, NPI714820H, NPI714750H, NPI714764H, NPI714771H, NPI714794H, NPI714682H, NPI714709H, NPI714710H, NPI714594H, NPI714598H, NPI714599H, NPI714602H, NPI714603H, NPI714606H, NPI714564H, NPI714572H, NPI714574H, NPI714587H, NPI714588H, NPI714589H, NPI714373H, NPI714379H, NPI714331H, NPI714346H, NPI714358H, NPI714378H, NPI714128H, NPI714160H, NPI714060H, NPI713947H, NPI713956H, NPI713957H, NPI714001H, NPI714017H, NPI713948H, NPI713949H, NPI713951H, NPI713952H, NPI713953H, NPI713954H, NPI713955H, NPI713829H, NPI713371H, NPI713372H, NPI713422H, NPI713242H, NPI713188H, NPI712940H, NPI712785H, NPI712637H, NPI712405H, NPI712411H, NPI712412H, NPI712341H, NPI712302H, NPI712256H, NPI711876H, NPI711841H, NPI711475H, NPI711476H, NPI710876H, NPI710765H, NPI710561H, NPI710071H, NPI709964H, NPI709680H, NPI709654H, NPI709655H, NPI709575H, NPI708692H, NPI708699H, NPI708702H, NPI708709H, NPI708675H, NPI708653H, NPI708635H, NPI708457H, NPI708415H, NPI708417H, NPI708425H, NPI708367H, NPI708376H, NPI708358H, NPI708316H, NPI708288H, NPI708289H, NPI708292H, NPI708295H, NPI708299H, NPI708300H, NPI708305H, NPI708306H, NPI708309H, NPI708258H, NPI708262H, NPI708273H, NPI708127H, NPI708128H, NPI708153H, NPI708101H, NPI708102H, NPI708103H, NPI708106H, NPI708107H, NPI708110H, NPI708112H, NPI708113H, NPI708114H, NPI708117H, NPI708118H, NPI708120H, NPI708121H, NPI708123H, NPI708124H, NPI708125H, NPI708079H, NPI708080H, NPI708082H, NPI708083H, NPI708084H, NPI708085H, NPI708086H, NPI708087H, NPI708088H, NPI708089H, NPI708090H, NPI708091H, NPI708092H, NPI708093H, NPI708094H, NPI708095H, NPI708096H, NPI708097H, NPI708100H, NPI708105H, NPI708108H, NPI708109H, NPI708116H, NPI708126H, NPI708056H, NPI708059H, NPI708060H, NPI708062H, NPI708063H, NPI708064H, NPI708065H, NPI708066H, NPI708067H, NPI708068H, NPI708070H, NPI708071H, NPI708073H, NPI708074H, NPI708076H, NPI708077H, NPI708078H, NPI708081H, NPI708014H, NPI708037H, NPI708038H, NPI708039H, NPI708040H, NPI708041H, NPI708042H, NPI708043H, NPI708044H, NPI708045H, NPI708046H, NPI708048H, NPI708049H, NPI708050H, NPI708055H, NPI708057H, NPI707998H, NPI707999H, NPI708001H, NPI708002H, NPI708003H, NPI708004H, NPI708005H, NPI708007H, NPI708008H, NPI708009H, NPI708011H, NPI708012H, NPI708013H, NPI708015H, NPI708016H, NPI708017H, NPI708018H, NPI708020H, NPI708021H, NPI708022H, NPI708023H, NPI708024H, NPI708025H, NPI708026H, NPI708027H, NPI708028H, NPI708030H, NPI708031H, NPI708033H, NPI708034H, NPI708036H, NPI707947H, NPI707955H, NPI707956H, NPI707961H, NPI707964H, NPI707970H, NPI707972H, NPI707975H, NPI707978H, NPI707979H, NPI707982H, NPI707983H, NPI707985H, NPI707986H, NPI707987H, NPI707989H, NPI707990H, NPI707991H, NPI707992H, NPI707993H, NPI707995H, NPI707996H, NPI707997H, NPI708000H, NPI707942H, NPI707943H, NPI707944H, NPI707945H, NPI707946H, NPI707948H, NPI707949H, NPI707950H, NPI707951H, NPI707952H, NPI707953H, NPI707954H, NPI707957H, NPI707958H, NPI707959H, NPI707962H, NPI707963H, NPI707966H, NPI707968H, NPI707969H, NPI707971H, NPI707974H, NPI707976H, NPI707977H, NPI707918H, NPI707919H, NPI707920H, NPI707922H, NPI707923H, NPI707924H, NPI707925H, NPI707927H, NPI707928H, NPI707929H, NPI707930H, NPI707931H, NPI707932H, NPI707934H, NPI707935H, NPI707937H, NPI707938H, NPI707939H, NPI707880H, NPI707881H, NPI707883H, NPI707884H, NPI707885H, NPI707886H, NPI707888H, NPI707890H, NPI707905H, NPI707907H, NPI707914H, NPI707916H, NPI707870H, NPI707871H, NPI707872H, NPI707873H, NPI707874H, NPI707875H, NPI707877H, NPI707879H, NPI707889H, NPI707893H, NPI707894H, NPI707895H, NPI707896H, NPI707897H, NPI707898H, NPI707899H, NPI707900H, NPI707901H, NPI707902H, NPI707846H, NPI707847H, NPI707848H, NPI707849H, NPI707856H, NPI707857H, NPI707858H, NPI707860H, NPI707861H, NPI707862H, NPI707864H, NPI707865H, NPI707867H, NPI707868H, NPI707869H, NPI707828H, NPI707830H, NPI707831H, NPI707832H, NPI707833H, NPI707834H, NPI707835H, NPI707836H, NPI707837H, NPI707838H, NPI707839H, NPI707840H, NPI707841H, NPI707842H, NPI707843H, NPI707844H, NPI707845H, NPI707851H, NPI707852H, NPI707855H, NPI707811H, NPI707812H, NPI707813H, NPI707814H, NPI707816H, NPI707818H, NPI707819H, NPI707820H, NPI707821H, NPI707822H, NPI707824H, NPI707791H, NPI707792H, NPI707794H, NPI707795H, NPI707797H, NPI707798H, NPI707799H, NPI707800H, NPI707802H, NPI707804H, NPI707805H, NPI707806H, NPI707807H, NPI707808H, NPI707809H, NPI707774H, NPI707776H, NPI707777H, NPI707779H, NPI707780H, NPI707782H, NPI707783H, NPI707784H, NPI707786H, NPI707788H, NPI707789H, NPI707790H, NPI707749H, NPI707750H, NPI707752H, NPI707753H, NPI707754H, NPI707755H, NPI707756H, NPI707757H, NPI707758H, NPI707762H, NPI707763H, NPI707764H, NPI707765H, NPI707766H, NPI707767H, NPI707768H, NPI707769H, NPI707770H, NPI707771H, NPI707772H, NPI707720H, NPI707721H, NPI707722H, NPI707723H, NPI707724H, NPI707725H, NPI707727H, NPI707728H, NPI707730H, NPI707731H, NPI707732H, NPI707733H, NPI707… (truncated, 120757 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 19, 2021

Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP

An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety if used on patients.

ALL 50 STATES
▸Full report

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

Recall #:
89711
Lot/product code:
(UDI): (01)00817170020086; Lot: 2009231440; Serial Numbers: 807483, 807484, 807485, 807486, 807487, 807489, 807490, 807491, 807492, 807493, 807494, 807495, 807496, 807497, 807498, 807499, 807500, 807502, 807651, 807652, 807653, 807507, 807508, 807509, 807510, 807511, 807512, 807513, 807514, 807515, 807516, 807517, 807518, 807519, 807520, 807521, 807522, 807523, 807524, 807525, 807526, 807527, 807528, 807529, 807530, 807531, 807532, 807533, 807534, 807535, 807536, 807537, 807538, 807539, 807540, 807541, 807542, 807543, 807544, 807545, 807546, 807547, 807548, 807549, 807550, 807551, 807552, 807553, 807554, 807654, 807655, 807656, 807657, 807658
Recalling firm:
InfuTronix LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.

ALL 50 STATES
▸Full report

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

Recall #:
91853
Lot/product code:
GTIN: (01)00884838076747 (Model 709030), (01)00884838101456 (Model 709031; Serial Numbers: 10000000 10000001 10000002 10000003 10000004 10000006 10000007 10000010 10000011 10000012 10000013 10000014 10000015 10000016 10000019 10000020 10000021 10000022 10000023 10000024 10000025 10000026 10000027 10000029 10000030 10000031 10000032 10000034 10000035 10000036 10000037 10000038 10000040 10000041 10000042 10000043 10000044 10000045 10000046 10000047 10000048 10000049 10000050 10000051 10000052 10000053 10000054 10000055 10000056 10000057 10000058 10000060 10000061 10000063 10000064 10000065 10000066 10000067 10000068 10000069 10000070 10000071 10000072 10000073 10000075 10000076 10000078 10000079 10000080 10000081 10000082 10000083 10000087 10000089 10000090 10000092 10000093 10000094 10000095 10000096 10000097 10000099 10000100 10000102 10000103 10000104 10000107 10000108 10000109 10000111 10000112 10000114 10000115 10000116 10000117 10000118 10000119 10000121 10000122 10000124 10000125 10000126 10000127 10000130 10000131 10000133 10000134 10000135 10000136 10000137 10000138 10000139 10000140 10000144 10000145 10000149 10000151 10000152 10000156 10000165 10000166 10000168 10000169 10000170 10000171 10000174 10000176 10000178 10000179 10000180 10000184 10000185 10000186 10000187 10000188 10000189 10000190 10000191 10000194 10000198 10000199 10000202 10001000 10001001 10001010 10001070 10001071 10001072 10001073 10001074 10001075 10001076 10001078 10001079 10001080 10001081 10001082 10001083 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001094 10001095 10001096 10001097 10001098 10001099 10001100 10001216 10001218 17000018 17000164 18000069 11201-10 24233-03 24592-122 28 7175_04 7896_04 SN16000001 SN16000002 SN16000003 SN16000004 SN16000006 SN16000007 SN16000008 SN16000009 SN17000001 SN17000002 SN17000003 SN17000004 SN17000006 SN17000007 SN17000008 SN17000009 SN17000010 SN17000011 SN17000012 SN17000013 SN17000014 SN17000015 SN17000016 SN17000017 SN17000018 SN17000019 SN17000020 SN17000021 SN17000022 SN17000023 SN17000024 SN17000101 SN17000102 SN17000103 SN17000104 SN17000105 SN17000106 SN17000107 SN17000108 SN17000109 SN17000110 SN17000111 SN17000112 SN17000113 SN17000114 SN17000115 SN17000116 SN17000117 SN17000118 SN17000119 SN17000120 SN17000121 SN17000122 SN17000123 SN17000124 SN17000126 SN17000127 SN17000128 SN17000129 SN17000130 SN17000131 SN17000132 SN17000133 SN17000134 SN17000135 SN17000136 SN17000137 SN17000138 SN17000139 SN17000140 SN17000141 SN17000142 SN17000143 SN17000144 SN17000145 SN17000146 SN17000147 SN17000148 SN17000149 SN17000150 SN17000151 SN17000152 SN17000153 SN17000154 SN17000155 SN17000156 SN17000157 SN17000158 SN17000159 SN17000160 SN17000161 SN17000162 SN17000163 SN17000164 SN17000165 SN17000166 SN17000167 SN17000168 SN17000169 SN17000170 SN17000171 SN17000227 SN18000001 SN18000002 SN18000003 SN18000004 SN18000005 SN18000006 SN18000007 SN18000008 SN18000009 SN18000010 SN18000011 SN18000012 SN18000013 SN18000014 SN18000015 SN18000016 SN18000017 SN18000018 SN18000019 SN18000020 SN18000021 SN18000022 SN18000023 SN18000024 SN18000025 SN18000026 SN18000027 SN18000028 SN18000029 SN18000030 SN18000031 SN18000032 SN18000033 SN18000034 SN18000035 SN18000036 SN18000037 SN18000038 SN18000039 SN18000041 SN18000044 SN18000045 SN18000046 SN18000047 SN18000048 SN18000049 SN18000050 SN18000051 SN18000052 SN18000053 SN18000054 SN18000055 SN18000056 SN18000057 SN18000058 SN18000060 SN18000061 SN18000062 SN18000063 SN18000064 SN18000065 SN18000066 SN18000067 SN18000068 SN18000069 SN18000070 SN18000071 SN18000072 SN18000073 SN18000074 SN18000075 SN18000076 SN18000077 SN18000078 SN18000079 SN19000001 SN19000002 SN19000003 SN19000004 SN19000005 SN19000006 SN19000007 SN19000008 SN19000009 SN19000010 SN19000011 SN19000012 SN19000013 SN19000014 SN19000015 SN19000016 SN19000017 SN19000018 SN19000019 SN19000020 SN19000021 SN19000022 SN19000023 SN19000024 SN19000025 SN19000026 SN19000027 SN19000028 SN19000029 SN19000030 SN19000031 SN19000032 SN19000033 SN19000034 SN19000035 SN19000036 SN19000037 SN19000038 SN19000039 SN19000040 SN19000041 SN19000042 10001004 10001005 10001006 10001008 10001009 10001010 10001011 10001012 10001013 10001018 10001020 10001022 10001024 10001026 10001027 10001028 10001029 10001030 10001031 10001032 10001035 10001036 10001043 10001044 10001045 10001046 10001047 10001048 10001049 10001050 10001051 10001052 10001053 10001054 10001055 10001056 10001057 10001058 10001059 10001060 10001061 10001062 10001063 10001064 10001065 10001066 10001067 10001068 10001069 10001070 10001071 10001072 10001073 10001074 10001075 10001076 10001077 10001078 10001079 10001080 10001081 10001083 10001084 10001085 10001086 10001087 10001088 10001089 10001090 10001091 10001092 10001093 10001093 10001094 10001095 10001096 10001097 10001098 10001099 10001100 10001101 10001102 10001103 10001104 10001105 10001106 10001107 10001108 10001109 10001110 10001111 10001112 1000… (truncated, 5112 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)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.

ALL 50 STATES
▸Full report

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

Recall #:
91853
Lot/product code:
GTIN: (01)00884838085619 (Model 706100), (01)00884838103221 (Model 709031); Serial Numbers: 597241 10000000 10000001 10000004 10000005 10000006 10000008 10000009 10000010 10000011 10000012 10000013 10000014 10000015 10000016 10000017 10000018 10000019 10000020 10000021 10000022 10000023 10000024 10000025 10000026 10000027 10000028 10000030 10000031 10000032 10000033 10000034 10000035 10000036 10000037 10000039 10000040 10000041 10000042 10000043 10000044 10000045 10000046 10000047 10000048 10000049 10000050 10000051 10000052 10000053 10000054 10000055 10001013 10001014 10001015 10001017 10001018 10001019 10001020 10001021 10001022 10001023 10001024 10001025 10001026 10001027 10001028 10001029 10001030 10001031 10001032 10001033 10001034 10001035 10001036 10001037 10001038 10001039 10001040 10001041 10001042 10001043 10001044 10001046 10001047 10001048 10001049 10001050 10001051 10001053 10001054 10001059 18000001 20000022 20000026 20000034 20000044 20000045 20000046 20000051 20000052 20000054 20000055 20000061 20000062 20000063 20000064 20000065 20000066 20000067 20000068 20000069 20000070 20000071 20000072 20000073 20000074 20000077 20000078 20000079 20000081 20000082 20000083 20000085 20000086 20000089 721815121706 SN10001000 SN10001001 SN10001002 SN10001003 SN10001004 SN10001005 SN10001006 SN10001007 SN10001008 SN10001009 SN10001010 SN10001011 SN10001012 SN18000001 SN18000002 SN18000003 SN18000004 SN18000005 SN18000006 SN18000007 SN18000008 SN18000009 SN18000011 SN18000012 SN18000013 SN18000014 SN18000015 SN18000016 SN18000017 SN18000018 SN18000019 SN18000020 SN18000021 SN18000022 SN18000023 SN18000024 SN18000152 SN18000249 SN19000001 SN19000002 SN19000003 SN19000004 SN19000005 SN19000006 SN19000007 SN19000008 SN19000009 SN19000010 SN19000011 SN19000012 SN19000013 SN19000014 SN19000015 SN19000016 SN19000017 SN19000018 10001057 10001064 10001059 10001058 10001062 10001069 10001052 10001060 10001070 10001061 10001063 10001068 10001067 10001066 10001073 10001065 10001103 10001075 10001079 10001085 10001084 10001074 10001106 10001087 10001088 10001076 10001086 10001093 10001091 10001089 10001100 10001099 10001104 10001078 10001098 10001102 10001105 10001072 10001096 10001090 10001077 10001118 10001109 10001110 10001107 10001112 10001092 10001111 10001113 10001101 10001116 10001108 10001045 10001055 10001083 10001095 10001094 10001071 10001082 10001080
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)

Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.

AKALARAZCACOCTDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWI
▸Full report

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

Recall #:
88986
Lot/product code:
Catalys-U and Catalys-I with Windows 7 Ultimate/Professional/Embedded Standard. Catalys-C with Windows 7 Embedded Standard. 0160-6020 and 0160-6010 with Windows 7 Professional/Embedded Standard.
Recalling firm:
AMO Manufacturing USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

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▸Full report

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

Recall #:
88991
Lot/product code:
GTIN: 08714729283836 Batches: 25576770, 25576881, 25576882, 25576883, 25576884, 25576885, 25608762, 25623386, 25623387, 25623388, 25623389, 25623390, 25623391, 25623392, 25623393, 25623394, 25623395, 25623396, 25623397, 25623398, 25649814, 25649817, 25649820, 25649821, 25649825, 25649826, 25649830, 25649831, 25678823, 25678827, 25678832, 25678837, 25680097, 25704217, 25704218, 25704219, 25704220, 25704221, 25704222, 25704223, 25739152, 25739153, 25739154, 25739155, 25739157, 25739158, 25771773, 25771774, 25771775, 25771776, 25771777, 25771778, 25836083, 25836084, 25836085, 25836086, 25836087, 25836088, 25836089, 25836090, 25836091, 25836092, 25878557, 25878558, 25878559, 25878980, 25878981, 25878982, 25878983, 25878984, 25878985, 25940124, 25940125, 25942723, 25947907, 25947909, 25947911, 25947913, 25947915, 25975775, 25975776, 25975777, 25975778, 25995786, 25996198, 26000471, 26000476, 26000477, 26000478, 26000479, 26000580, 26000700, 26010393, 26010394, 26010395, 26010396, 26058288, 26058291, 26058293, 26058294, 26058295, 26058296, 26058297, 26087734, 26087735, 26087736, 26087737, 26087738, 26087739, 26087740, 26087741, 26123187, 26123188, 26123189, 26123190, 26123191, 26123247, 26123248, 26123249, 26175470, 26175471, 26175472, 26175473, 26207983, 26207984, 26207985, 26207986, 26207987, 26207988, 26207989, 26207990, 26207991, 26238132, 26238133, 26238134, 26240368, 26240370, 26240371, 26240373, 26247248, 26247249, 26247250, 26247251, 26247252, 26247253, 26247254, 26247255, 26247256, 26247257, 26283632, 26283633, 26283634, 26283635, 26283636, 26283637, 26283638, 26283639, 26284140, 26284141, 26284142, 26284143, 26324749, 26324751, 26324752, 26324754, 26350404, 26350405, 26350406, 26350407, 26356444, 26366753, 26366754, 26366755, 26366756, 26366757, 26406522, 26406523, 26406524, 26406525, 26406526, 26406527, 26406528, 26406529, 26406530, 26406531, 26426921, 26426922, 26426923, 26428970, 26429811, 26429812, 26435537, 26435538, 26435539, 26435580, 26452047, 26456916, 26456917, 26462399, 26473523, 26473769, 26473770, 26473771, 26473772, 26473773, 26473774, 26495372, 26495950, 26500637, 26500638, 26512452, 26512453, 26512454, 26512455, 26512456, 26512457, 26512458, 26512459, 26512480, 26512481, 26512483, 26512485, 26549972, 26552065, 26556788, 26556789, 26559542, 26559543, 26559544, 26559548, 26581407, 26581408, 26582103, 26582104, 26582105, 26582106, 26582107, 26588072, 26588073, 26588074, 26588075, 26588076, 26628443, 26628444, 26638830, 26638831, 26651713, 26651714, 26651715, 26651716, 26665561, 26665567, 26665571, 26665572, 26665573, 26685875, 26685876, 26685877, 26685878, 26685879, 26699192, 26699193, 26699194, 26699195, 26699196, 26699197, 26728782, 26728784, 26728785, 26759345, 26760530, 26778894, 26778895, 26778896, 26778897, 26778898, 26779080, 26779081, 26779082, 26779083, 26793782, 26793783, 26793784, 26808197, 26808198, 26808199, 26808300, 26808301, 26808302, 26808303, 26848720, 26848721, 26848722, 26848723, 26848724, 26848725, 26871168, 26871169, 26871170, 26871171, 26871172, 26871173, 26871174, 26910997, 26910998, 26910999, 26911840, 26911841, 26911842, 26911845, 26919040, 26919041, 26919042, 26960166, 26960167, 26960168, 26960169, 26960170, 26960171, 26960172, 26960173, 26960174, 26960175, 27009668, 27027289, 27027290, 27027291, 27027292, 27062054, 27062055, 27062056, 27062057, 27065830, 27065831, 27065832, 27065833, 27065834, 27065835, 27100017, 27100018, 27100019, 27100240, 27100241, 27100242, 27110096, 27110097, 27121582, 27121583, 27121584, 27121585, 27121620, 27121621, 27121625, 27148636, 27148637, 27148638, 27162326, 27162327, 27162328, 27162329, 27182896, 27182897, 27182898, 27182899, 27203768, 27203769, 27203770, 27203771, 27203772, 27203773, 27255217, 27255219, 27255220, 27255221, 27255222, 27255223, 27308422, 27308423, 27308424, 27308425, 27335091, 27335092, 27335093, 27335094, 27340629, 27340630, 27340632, 27340633, 27340634, 27340638, 27347592, 27347593, 27384705, 27384706, 27384713, 27384715. Exp. 05/10/2022 to 05/26/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.

AKALARAZCACOCTDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPASCSDTNTXUTVAVTWAWI
▸Full report

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

Recall #:
88986
Lot/product code:
G300 with Windows XP. G301 with Windows 7 Embedded System.
Recalling firm:
AMO Manufacturing USA, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2021

HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

ALL 50 STATES
▸Full report

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

Recall #:
88991
Lot/product code:
GTIN: 08714729283805 Lot Numbers: 25612668, 25649812, 25704208, 25771760, 25878552, 26000695, 26010387, 26058284, 26087172, 26087173, 26123181, 26324742, 26366746, 26406513, 26429808, 26499853, 26527374, 26573853, 26638827, 26651718, 26665448, 26893604, 27026984, 27074109, 27145234, 27162321, 27255235, 27306699. Exp. 05/19/2022 to 05/13/2023
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)