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Recalls affecting North Dakota

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

16,365 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled 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 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 WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.

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

ALL 50 STATES
▸Full report

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

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

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

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

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAWAWIWVWY
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

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

Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG

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

ALL 50 STATES
▸Full report

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

Recall #:
89062
Lot/product code:
LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: TDXSP2 00841447100911 TDXSP2-CG 00841447100942 TDXSP2-MCG 00841447100966 TDXSP2HD 00841447108641 TDXSP2HD-CG 00841447111207 TDXSP2HD-MCG 00841447111214 TDXSP2V 00841447101512 TDXSP2V-HD 00841447102052 TDXSP2X-CG 00841447101000 TDXSP2X-MCG 00841447101017
Recalling firm:
Invacare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2021

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

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

ALL 50 STATES
▸Full report

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

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

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

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

ALL 50 STATES
▸Full report

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

Recall #:
89062
Lot/product code:
LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: IFX-20C 00841447111627 IFX-20MP 00841447111658 IFX-20R 00841447111634 IFX-20SP 00841447111641 IFX20WIDE 00841447111658
Recalling firm:
Invacare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2021

BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075

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 Number: 173 105 5301 4950 5360 4651 4891 873 1633 160 543 562 204 5090 5091 5092 4840 5073 125 383 384 5121 UDI: (01)00884838055490(21)173 (01)00884838055490(21)105 (01)00884838055490(21)5301 (01)00884838055490(21)4950 (01)00884838055490(21)5360 (01)00884838055490(21)4651 (01)00884838055490(21)4891 (01)00884838055490(21)873 (01)00884838055490(21)1633 (01)00884838055490(21)160 (01)00884838055490(21)543 (01)00884838055490(21)562 (01)00884838055490(21)204 (01)00884838055490(21)5090 (01)00884838055490(21)5091 (01)00884838055490(21)5092 (01)00884838055490(21)4840 (01)00884838055490(21)5073 (01)00884838055490(21)125 (01)00884838055490(21)383 (01)00884838055490(21)384 (01)00884838055490(21)5121
Recalling firm:
Philips North America Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.

ALL 50 STATES
▸Full report

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

Recall #:
89139
Lot/product code:
Software Version VA25A/B System Serial Numbers: 800101 800106 800117 800126 800135 800136 800138 800140 800142 800147 800157 800159 800162 800163 800171 800176 800177 800181 800182 800183 800184 800185 800186 800187 800190 800191 800192 800196 800199 800203 800205 800206 800207 800211 800212 800213 800218 800219 800220 800223 800225 800226 800228 800229 800230 800232 800236 800237 800241 800244 800249 800250 800251 800255 800256 800258 800260 800265 800267 800273 800275 800278 800279 800281 800285 800286 800288 800290 800291 800292 800294 800295 800302 800304 800305 800314 800315 800319 800328 800334 800335 800338 800339 800341 800346 800356 800357 800360 800362 800368 800369 800371 800375 800383 800388 800390 800391 800397 800399 800405 800406 800408 800411 800426 800428 800433 800435 800436 800439 800449 800451 800454 800458 800463 800464 800466 800467 800468 800472 800473 800474 800483 800490 800517 800530 800532 800535 800545 800549 800551 800555 800557 800559 800566 800575 800585 800590 800593 800594 800595 800598 800599 800601 800606 800610 800611 800612 800618 800620 800625 800627 800638 800639 800644 800645 800646 800647 800649 800659 800661 800669 800671 800673 800674 800686 800688 800696 800701 800703 800705 800707 800708 800730 800731 800735 800745 800756 800758 800761 800763 800771 800779 800787 800788 800789 800799 800804 800805 800807 800809 800820 800821 800822 800850 800861 800871 800877 800879 800881 800884 800885 800887 800890 800895 800896 800897 800905 800914 800922 800925 800928 800932 800934 800938 800940 800950 800952 800961 800963 800964 800977 800979 800980 800990 800991 800993 800994 800998 801001 801002 801007 801009 801017 801023 801024 801026 801033 801036 801047 801065 801080 801083 801085 801122 801128 801130 801131 801132 801133 801135 801139 801140 801162 801165 801166 801196 801202 801211 801223 801225 801232 801249 801252 801261 801269 801270 801278 801286 801288 801291 801292 801293 801294 801295 801296 801297 801299 801301 801302 801303 801305 801307 801309 801312 801315 801318 801320 801321 801322 801328 801329 801334 801342 801344 801345 801346 801347 801352 801353 801357 801359 801363 801367 801371 801383 801386 801390 801392 801399 801400 801405 801408 801413 801417 801419 801420 801422 801427 801430 801435 801436 801441 801443 801447 801451 801452 801454 801456 801462 801466 801467 801472 801476 801480 801483 801486 801487 801488 801491 801492 801496 801498 801501 801503 801506 801507 801511 801512 801513 801517 801518 801519 801521 801522 801523 801524 801526 801529 801533 801539 801544 801549 801555 801556 801558 801563 801564 801565 801566 801567 801569 801570 801579 801584 801589 801592 801595 801597 801599 801600 801603 801605 801609 801610 801612 801613 801614 801615 801616 801617 801618 801620 801621 801622 801623 801624 801625 801627 801628 801630 801633 801639 801640 801642 801644 801646 801650 801651 801662 801663 801669 801670 801671 801673 801674 801677 801679 801681 801683 801684 801685 801686 801687 801688 801689 801690 801691 801692 801693 801694 801695 801696 801697 801698 801699 801700 801701 801702 801703 801704 801705 801706 801707 801709 801710 801711 801712 801713 801714 801715 801716 801717 801718 801720 801721 801722 801723 801724 801725 801726 801727 801728 801729 801730 801731 801732 801733 801734 801735 801736 801737 801738 801739 801740 801741 801742 801743 801744 801745 801746 801747 801748 801749 801750 801751 801752 801753 801754 801755 801756 801757 801758 801759 801762 801764 801766 801772 801777 801778 801779 801782 801791 801796 801797 801798 801801 801802 801803 801804 801808 801809 801818 801822 801829 801836 801837 801839 801846 801847 801849 801852 801854 801857 801858 801859 801860 801865 801868 801870 801871 801872 801873 801874 801877 801878 801879 801880 801881 801883 801884 801886 801892 801893 801902 801903 801906 801913 801914 801916 801917 801918 801919 801921 801922 801923 801924 801925 801926 801928 801929 801930 801931 801932 801938 801940 801941 801943 801944 801945 801946 801947 801948 801949 801950 801951 801952 801953 801954 801955 801956 801957 801958 801959 801960 801961 801964 801966 801969 801970 801973 801976 801989 801993 801996 801997 801998 802002 802006 802012 802013 802015 802020 802021 802023 802025 802026 802028 802030 802031 802034 802035 802036 802037 802038 802039 802040 802041 802042 802043 802044 802045 802046 802047 802049 802050 802051 802054 802056 802057 802058 802059 802060 802061 802063 802064 802065 802066 802067 802068 802071 802074 802075 802076 802077 802085 802088 802089 802090 802096 802097 802100 802103 802104 802110 802111 802113 802114 802116 802118 802122 802127 802128 802129 802132 802142 802144 802149 802151 802152 802153 802154 802155 802156 802157 802158 802159 802160 802161 802162 802163 802165 802166 802167 802168 802169 802170 802172 802173 802174 802175 802176 802177 802178 802182 802184 802190 802191 802192 802194 802195 802196 802197 802198 802199 802200 802201 802204 80… (truncated, 8175 characters total — see the official FDA record for the full value)
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2021

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

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

ALL 50 STATES
▸Full report

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

Recall #:
89062
Lot/product code:
LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: SRX-20MP 00841447114581 SRX-20R 00841447114604 SRX-20SP 00841447114598
Recalling firm:
Invacare Corporation
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 2714 13751 852 853 13476 1070 3986 2548 816 137 410 859 2867 1016 1656 2110 2435 2917 13257 13258 284 218 2204 2231 1682 1900 1193 746 87 2541 3486 247 248 624 1108 350 169 610 474 355 356 894 295 300 220 2128 67 1712 2259 3944 150 898 717 860 1017 2959 4345 190 1377 2618 2425 659 138 1156 13203 13477 1298 1258 2094 168 167 317 1662 217 12681 2443 1936 2573 3102 195 134 135 682 2759 3892 3121 1203 3398 1758 13707 1784 12454 515 2271 250 721 478 57 2747 1425 750 2588 621 934 1066 1605 1658 2186 3187 3237 3239 12923 12924 985 1603 4239 4240 13212 12463 3418 4528 4529 3744 4264 126 3087 892 1307 668 3802 2439 4616 12922 13779 13026 13029 13496 13025 2549 13538 13539 3573 13028 733 12650 1685 1959 3584 3661 3663 4706 12466 13032 13498 3662 13030 13033 690 2722 1681 1526 3091 13530 141 142 143 148 149 1598 1599 1600 1601 12904 706 12766 705 707 688 1420 1421 2491 2557 2558 2560 2005 2018 521 4212 4213 12990 12991 1654 1655 2225 2226 2670 1260 2041 614 321 2044 1922 2127 1251 128 180 2428 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)
UnclassifiedRisk not yet known
Medical deviceRecalled November 12, 2021

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

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: As-Maintained System Serial Number 1442 1517 1367 1088 1210 209 422 35 261 692 1468 1469 1470 1471 990 1447 578 579 318 103 1067 518 1022 1513 73 548 549 710 711 107 352 539 319 655 1512 2138 1643 1059 36 1058 1647 1201 884 835 836 1613 769 284 232 1253 1254 1255 427 428 429 618 1203 379 705 708 532 706 707 669 1583 1368 1369 88 84 126 971 218 1696 612 133 1770 458 496 1073 1324 982 1756 351 890 1199 1926 1540 1541 642 433 832 1916 776 664 1545 267 1955 1195 432 632 283 2044 1221 1222 187 188 190 919 1121 34 1491 1320 1187 945 540 1041 1440 1049 1050 1051 1052 1053 1614 425 437 1006 1007 1343 517 1497 80 113 257 303 304 305 306 307 2255 1310 668 673 1760 1797 1798 489 629 750 1060 1337 1338 2059 2094 2095 2104 1336 1335 1178 1692 1693 1694 1695 915 1394 974 975 976 977 613 1448 203 1261 611 1732 1737 375 1466 1467 944 1429 716 324 1963 651 972 702 1799 1869 1870 2063 2062 1134 888 519 33 591 610 1645 1683 1893 211 544 219 2121 411 430 641 643 645 652 928 175 174 256 159 806 328 240 620 1057 520 1188 1025 1027 1083 1103 682 987 1644 993 204 205 340 1675 1808 1809 76 77 568 1125 1126 659 1101 1451 1452 943 1120 1985 1136 179 180 181 182 183 184 464 889 1153 1154 1232 1649 1010 962 445 2036 1004 1516 75 1017 1395 1514 858 927 85 1133 462 523 1628 368 980 1008 1009 1054 584 1979 1980 1309 721 724 94 1319 1119 983 485 916 1342 431 901 1021 1026 722 715 1592 1593 254 286 1347 1578 424 136 137 2180 323 216 1747 89 1856 2099 587 592 1190 1860 2199 1861 1828 134 994 448 1615 833 859 396 337 1312 883 886 1068 1960 1311 237 925 926 936 1749 985 1949 1767 1768 657 1533 189 1928 751 871 872 873 874 1211 236 1911 385 386 924 1416 1534 1097 1098 831 1677 370 405 1558 1671 138 1641 718 719 720 68 58 67 69 71 72 903 350 426 2137 434 435 436 409 404 1733 1100 1684 1260 1262 573 1207 1198 736 1189 885 270 262 961 387 388 367 1314 1194 530 1612 215 986 521 378 1122 1868 1065 513 792 1127 74 569 127 128 129 130 402 704 777 1208 1209 654 272 1239 210 265 2208 666 674 277 1702 675 685 688 667 681 703 112 120 1413 1414 1096 1104 1105 671 672 371 515 UDI: (01)00884838058194(21)1442 (01)00884838058194(21)1517 (01)00884838058194(21)1367 (01)00884838058194(21)1088 (01)00884838058194(21)1210 (01)00884838058194(21)209 (01)00884838058194(21)422 (01)00884838058194(21)35 (01)00884838058194(21)261 (01)00884838058194(21)692 (01)00884838058194(21)1468 (01)00884838058194(21)1469 (01)00884838058194(21)1470 (01)00884838058194(21)1471 (01)00884838058194(21)990 (01)00884838058194(21)1447 (01)00884838058194(21)578 (01)00884838058194(21)579 (01)00884838058194(21)318 (01)00884838058194(21)103 (01)00884838058194(21)1067 (01)00884838058194(21)518 (01)00884838058194(21)1022 (01)00884838058194(21)1513 (01)00884838058194(21)73 (01)00884838058194(21)548 (01)00884838058194(21)549 (01)00884838058194(21)710 (01)00884838058194(21)711 (01)00884838058194(21)107 (01)00884838058194(21)352 (01)00884838058194(21)539 (01)00884838058194(21)319 (01)00884838058194(21)655 (01)00884838058194(21)1512 (01)00884838058194(21)2138 (01)00884838058194(21)1643 (01)00884838058194(21)1059 (01)00884838058194(21)36 (01)00884838058194(21)1058 (01)00884838058194(21)1647 (01)00884838058194(21)1201 (01)00884838058194(21)884 (01)00884838058194(21)835 (01)00884838058194(21)836 (01)00884838058194(21)1613 (01)00884838058194(21)769 (01)00884838058194(21)284 (01)00884838058194(21)232 (01)00884838058194(21)1253 (01)00884838058194(21)1254 (01)00884838058194(21)1255 (01)00884838058194(21)427 (01)00884838058194(21)428 (01)00884838058194(21)429 (01)00884838058194(21)618 (01)00884838058194(21)1203 (01)00884838058194(21)379 (01)00884838058194(21)705 (01)00884838058194(21)708 (01)00884838058194(21)532 (01)00884838058194(21)706 (01)00884838058194(21)707 (01)00884838058194(21)669 (01)00884838058194(21)1583 (01)00884838058194(21)1368 (01)00884838058194(21)1369 (01)00884838058194(21)88 (01)00884838058194(21)84 (01)00884838058194(21)126 (01)00884838058194(21)971 (01)00884838058194(21)218 (01)00884838058194(21)1696 (01)00884838058194(21)612 (01)00884838058194(21)133 (01)00884838058194(21)1770 (01)00884838058194(21)458 (01)00884838058194(21)496 (01)00884838058194(21)1073 (01)00884838058194(21)1324 (01)00884838058194(21)982 (01)00884838058194(21)1756 (01)00884838058194(21)351 (01)00884838058194(21)890 (01)00884838058194(21)1199 (01)00884838058194(21)1926 (01)00884838058194(21)1540 (01)00884838058194(21)1541 (01)00884838058194(21)642 (01)00884838058194(21)433 (01)00884838058194(21)832 (01)00884838058194(21)1916 (01)00884838058194(21)776 (01)00884838058194(21)664 (01)00884838058194(21)1545 (01)00884838058194(21)267 (01)00884838058194(21)1955 (01)00884838058194(21)1195 (01)00884838058194(21)432 (01)00884838058194(21)632 (01)00884838058194(21)283 (01)00884838058194(21)2044 (01)00884838058194(21)1221 (01)00884838058194(21)1222 (01)00884838058194(21)187 (01)00884838058194(21)188 (01)00884838058194(21)190 (01)00884838058194(21)919 (01)00884838058194(21)1121 (01)00884838058194(21)34 (01)0088483805819… (truncated, 14274 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 November 15, 2021

Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45, 0998-UC-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-UC-0800-65.

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

ALL 50 STATES
▸Full report

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

Recall #:
88983
Lot/product code:
All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-UC-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-UC-0800-32, 10607567111117; 0998-00-0800-33, 10607567109008; 0998-UC-0800-33, 10607567109008; 0998-00-0800-34, 10607567111940; 0998-UC-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-UC-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 0998-UC-0800-36, 10607567114187; 0998-00-0800-45, 10607567108421; 0998-UC-0800-45, 10607567108421; 0998-00-0800-52, 10607567108438; 0998-UC-0800-52, 10607567108438; 0998-00-0800-53, 10607567108391; 0998-UC-0800-53, 10607567108391; 0998-00-0800-55, 10607567108414; 0998-UC-0800-55, 10607567108414; 0998-00-0800-65, 10607567113432; 0998-UC-0800-65, 10607567113432
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 15, 2021

Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.

Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.

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

Recall #:
88983
Lot/product code:
All Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-75, 10607567112312; 0998-UC-0800-75, 10607567112312; 0998-00-0800-83, 10607567108407; 0998-UC-0800-83, 10607567108407; 0998-00-0800-85, 10607567113449; 0998-UC-0800-85, 10607567113449.
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2021

Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.

Increase in premature device failures

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

Recall #:
88984
Lot/product code:
Shipped between March 2019 and February 2021.
Recalling firm:
Ohio Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 16, 2021

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.

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

Recall #:
89643
Lot/product code:
UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086
Recalling firm:
Roche Molecular Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2

Kit packaging may have small holes compromising product sterility

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3272267, 3274728, 3323887
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Senior Living Arial Emergency and Nurse Call Systems

Systems are not alarming due to increased memory consumption.

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

Recall #:
89181
Lot/product code:
Model No. 0900-989; Lot No.: 7VQYZB3, G1GG8B3, 1TX2613, 7VQWZB3, GRRT243, 1TX3613, G1H58B3, HJP7N23, HJP9N23, 51SDR33, and GRRV243; UDI No.: (01)00840948100987(21)7VQYZB3, (01)00840948100987(21)1TX2613, (01)00840948100987(21)7VQZZB3, (01)00840948100987(21)GRRT243, (01)00840948100987(21)G1GF8B3, (01)00840948100987(21)1TX3613, (01)00840948100987(21)G1H58B3, (01)00840948100987(21)HJP7N23, (01)00840948100987(21)HJP9N23, (01)00840948100987(21)51SDR33, (01)00840948100987(21)GRRV243
Recalling firm:
Stanley Security Solutions Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967

Kit packaging may have small holes compromising product sterility

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1

Kit packaging may have small holes compromising product sterility

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3289074
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

Kit packaging may have small holes compromising product sterility

CACOLAMAMDNDPATNUT
▸Full report

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 17, 2021

Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3

Kit packaging may have small holes compromising product sterility

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

Recall #:
89111
Lot/product code:
Lot Numbers: 3347921, 3358240
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)