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Recalls affecting Idaho

Data last updated: September 8, 2026 at 1:13 PM UTC

16,424 recalls found

Just announced

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

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

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
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UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2018

GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

ALL 50 STATES
▸Full report

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

Recall #:
81075
Lot/product code:
Serial Numbers: No UDI: SKA14365373GA SKA16085338SA SKA16085415SA SED11178711GA SED11178722GA SED11178730GA SED11178731GA SED12384211GA SKA16065074SA SKA16065096SA SKA16105698SA SKA16105700SA SED11148380GR SED11168558GR SED11229587GR SED12183123GA SED12183126GA SED12273483GA SED12353647GA SED12353648GA SED12363714GA SED12363728GA SED12373928GA SED09320537GA SED11300215GR SED11300224GR SED11300285GR SED11300317GR SED11300318GR SED11420905GR SED11420906GR SED11420913GR SED11420919GR SED11420923GR SED11420926GR SED11420927GR SED11420928GR SED11420929GR SED11420930GR SED11420931GR SED11430946GR SED11430947GR SED11430949GR SED11430967GR SED11430970GR SED11430971GR SED12152834GR SED12152838GR SED12203208GR SED12203211GR SED12203212GR SED12203213GR SED12203254GR SED12203257GR SED12203258GR SED12203259GR SED12253445GR SED12263455GR SKA14365468GA SED11097478GR SED11158484GR SED11229574GR SED11229586GR SED11229600GR SED11290119GR SED11290121GR SED11290179GR SED11300185GR SED11300206GR SED11300237GR SED11400754GR SED11400808GR SED11400820GR SED11400822GR SED11410865GR SED12011230GR SED12061751GR SED12061776GR SED12092232GR SED12203277GR SED12263465GR SED12374154GR SKA14042213GA SKA14042214GA SKA14042217GA SKA14042221GA SED10384067GA SED11117907GA SED11117984GA SED14011320GA SED12384438GA SED12384442GA SED12384447GA SED12384459GA SED12384462GA SED12384465GA SED12384467GA SED12384473GA SED12384476GA SED12384477GA SED12384480GA SED12384482GA SKA15150527GA SKA15160548GA SED11087355GA SED11087409GA SED12092223GA SED12092227GA SED12485925GA SED12485926GA SKA15109642GA SKA15109644GA SKA15109647GA SED09370825GA SKA15361685SA SKA15361687SA SED12173064GR SED10132516GA SED10142524GA SED10142526GA SED10142528GA SED10252889GA SED10252891GA SED10252895GA SED10252920GA SED10252921GA SED10252922GA SED10252926GA SED11320473GA SED11320475GA SED11461073GA SKA16075189SA SKA16075222SA SKA16075223SA SED11178786GA SED11178791GA SED11178795GA SED11178801GA SKA15412512SA SKA14062442GR SKA14143028GR SED13270081GA SED13270083GA SED13270084GA SED13270085GA SED13270086GA SED13270087GA SED13270088GA SED13270089GA SED13270095GA SED13270096GA SED13270101GA SED13270102GA SED13270103GA SED13270104GA SED13270105GA SED13270106GA SED13270108GA SED13270109GA SED13270111GA SED13270178GA SED13270180GA SED13270185GA SED13270187GA SED13270209GA SED13270212GA SED13270213GA SED13270215GA SED13270244GA SED13270245GA SED13270246GA SED13280250GA SED13280251GA SKA15422750SA SKA15422763SA SKA15422765SA SKA15422770SA SKA13460951GA SKA13460956GA SED10526109GA SED10526110GA SED11057059GA SED11077143GA SED11077176GA SED11077185GA SED11077209GA SED11087302GA SED11087413GA SED11097419GA SED11097432GA SED11097439GA SED11097457GA SED11097458GA SED11158552GA SED11178737GA SED11178753GA SED11229501GA SED11229564GA SED11400745GA SED11400750GA SED11430964GA SED11430966GA SED11430975GA SED12082133GA SED12112499GA SED12112501GA SED12112516GA SED12112523GA SED12112525GA SED12112526GA SED12112527GA SED12112528GA SED12122617GA SED12122618GA SED12122619GA SED12122633GA SED12122634GA SED12142683GA SED12142684GA SED12142685GA SED12142686GA SED12142687GA SED12142688GA SED12142689GA SED12142690GA SED12142691GA SED12142692GA SED12142693GA SED12142694GA SED12142695GA SED12142696GA SED12142697GA SED12142698GA SED12142699GA SED12142700GA SED12142701GA SED12142702GA SED12142703GA SED12142704GA SED12142705GA SED12142706GA SED12142707GA SED12142708GA SED12142709GA SED12394558GA SKA14385621GA SKA14385622GA SKA14385624GA SKA14385626GA SKA14385627GA SKA14385628GA SKA14385629GA SKA14385631GA SKA14385632GA SKA14385633GA SKA14385634GA SKA14385635GA SKA14385636GA SKA14385637GA SKA14385638GA SKA14385639GA SED12506310GA SED12516400GA SED13280372GA SED13280377GA SED13280378GA SED13280387GA SED13280389GA SED13280392GA SED13280393GA SED13280394GA SED13280395GA SED13280396GA SED13280397GA SED13280399GA SED13280401GA SED13280402GA SED13280403GA SKA15048560GA SKA15048566GA SKA15140356GA SKA15140362GA SED13290477GA SED13290481GA SED13290483GA SED13290484GA SED13290491GA SED13290494GA SED13290495GA SED11420911GR SED11420916GR SED11420917GR SED11420921GR SED11420925GR SED11430952GR SED11430953GR SED11430956GR SED11430959GR SED11430963GR SED11430965GR SKA15180982GA SKA15180983GA SKA15180985GA SKA13130071GR SKA13130078GR SKA13130085GR SKA13310128GR SKA13310129GR SKA13370167GR SKA13370217GR SKA13370218GR SKA13370219GR SKA13370222GR SKA13370232GR SKA13370234GR SKA13370239GR SKA13370269GR SKA13370271GR SKA13390459GR SKA13440549GR SKA13450642GR SKA13450643GR SKA13450660GR SKA13450672GR SKA13450678GR SKA13450683GR SKA13450686GR SKA13450697GR SKA13450703GR SKA13450709GR SKA13450710GR SKA13450712GR SKA13481312GR SKA13491470GR SKA13491494GR SKA13491552GR SKA13501567GR SKA13501570GR SKA13501574GR SKA13501586GR SKA13501589GR SKA13501592GR SKA13501594GR SKA13501596GR SKA13501600GR SKA13501602GR SKA13501606GR SKA13501629GR SKA13511761GR SKA13511793GR SKA14042192GR SKA14143026GR SKA14143029GR SKA14143030GR SKA14233897GR SED110… (truncated, 1042289 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare Finland Oy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2018

B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

Patient monitors may restart due to network overload caused by network configuration.

ALL 50 STATES
▸Full report

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

Recall #:
81077
Lot/product code:
All monitors
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2018

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

ALL 50 STATES
▸Full report

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

Recall #:
81055
Lot/product code:
UDI - 10607567108391 All Serial Numbers
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 20, 2018

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

ALL 50 STATES
▸Full report

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

Recall #:
81055
Lot/product code:
UDI - 10607567108407 All Serial Numbers
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66615-A3539, 66615-A5098
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66641-A2630, 66641-A2683, 66641-A3005, 66641-A3560, 66641-A3796, 66641-A3979, 66641-A4220, 66641-A4473, 66641-A4543, 66641-A5066, 66641-A5283, 66641-A5412, 66641-A5556, 66641-A5671
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66616-A2442, 66616-A2524, 66616-A2725, 66616-A2906, 66616-A2974, 66616-A3033, 66616-A3309, 66616-A3310, 66616-A3318, 66616-A3520, 66616-A3554, 66616-A3559, 66616-A3737, 66616-A3773, 66616-A3794, 66616-A3977, 66616-A4081, 66616-A4147, 66616-A4443, 66616-A4516, 66616-A5064, 66616-A5281, 66616-A5410, 66616-A5550, 66616-A5669
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66631-A2443, 66631-A2564, 66631-A2629, 66631-A2772, 66631-A2975, 66631-A3004, 66631-A3311, 66631-A3456, 66631-A3483, 66631-A3553, 66631-A3558, 66631-A3738, 66631-A3774, 66631-A3795, 66631-A3978, 66631-A4082, 66631-A4148, 66631-A4444, 66631-A4517, 66631-A5065, 66631-A5282, 66631-A5411, 66631-A5555, 66631-A5670
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66640-A2404, 66640-A4324
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: H938905 63630-A1769, H938905 63630-A1771, H938905 63630-A1773, H938905 63630-A2647, H938905 63630-A2649, H938905 63630-A2651, H938905 63630-A2655, H938905 63630-A2657, H938905 63630-A2659, H938905 63630-A2661, H938905 63630-A3950, H938905 63630-A3952, H938905 63630-A3954, H938905 63630-A3956, H938905 63630-A3957, H938905 63630-A3959, H938905 63630-A3961, H938905 63630-A3963, H938905 63630-A3965, H938905 63630-A3968, H938905 63630- A5338, H938905 63630-A5340, H938905 63630-A5342, H938905 63630-A5344, H938905 63630-A5346, H938905 63630-A5348, H938905 63630-A5350
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: 66630-A2771, 66630-A4282
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 21, 2018

ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Potential for leaking product

ALL 50 STATES
▸Full report

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

Recall #:
83509
Lot/product code:
Lot Numbers: H938901 63615-A1768, H938901 63615-A1770, H938901 63615-A1772, H938901 63615-A2648, H938901 63615-A2650, H938901 63615-A2652, H938901 63615-A2653, H938901 63615-A2654, H938901 63615-A2656, H938901 63615-A2658, H938901 63615-A2660, H938901 63615-A2662, H938901 63615-A3951, H938901 63615- A3953, H938901 63615-A3955, H938901 63615-A3958, H938901 63615-A3960, H938901 63615-A3962, H938901 63615-A3964, H938901 63615-A3966, H938901 63615-A3967, H938901 63615-A5337, H938901 63615-A5339, H938901 63615-A5341, H938901 63615-A5343, H938901 63615-A5345, H938901 63615-A5347, H938901 63615-A5349
Recalling firm:
The Metrix Company
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 24, 2018

Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard

ALL 50 STATES
▸Full report

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

Recall #:
81092
Lot/product code:
Model Number 453564669081;  System Serial Number (UDI): US1814000001 ((01)00884838091474(21)US1814000001), US1814000002 ((01)00884838091474(21)US1814000002), US1814000003 ((01)00884838091474(21)US1814000003), US1814000004 ((01)00884838091474(21)US1814000004), US1814000006 ((01)00884838091474(21)US1814000006), US1814000007 ((01)00884838091474(21)US1814000007), US1814000008 ((01)00884838091474(21)US1814000008), US1814000011 ((01)00884838091474(21)US1814000011), US1814000012 ((01)00884838091474(21)US1814000012), US1814000013 ((01)00884838091474(21)US1814000013), US1814000014 ((01)00884838091474(21)US1814000014), US1814000016 ((01)00884838091474(21)US1814000016), US1814000017 ((01)00884838091474(21)US1814000017), US1814000018 ((01)00884838091474(21)US1814000018), US1814000019 ((01)00884838091474(21)US1814000019), US1814000020 ((01)00884838091474(21)US1814000020), US1814000022 ((01)00884838091474(21)US1814000022), US1814000023 ((01)00884838091474(21)US1814000023), US1814000024 ((01)00884838091474(21)US1814000024), US1814000027 ((01)00884838091474(21)US1814000027), US1814000028 ((01)00884838091474(21)US1814000028), US1814000029 ((01)00884838091474(21)US1814000029), US1814000030 ((01)00884838091474(21)US1814000030), US1814000031 ((01)00884838091474(21)US1814000031), US1814000032 ((01)00884838091474(21)US1814000032), US1814000033 ((01)00884838091474(21)US1814000033), US1814000034 ((01)00884838091474(21)US1814000034), US1814000035 ((01)00884838091474(21)US1814000035), US1814000036 ((01)00884838091474(21)US1814000036), US1814000037 ((01)00884838091474(21)US1814000037), US1814000038 ((01)00884838091474(21)US1814000038), US1814000039 ((01)00884838091474(21)US1814000039), US1814000040 ((01)00884838091474(21)US1814000040), US1814000041 ((01)00884838091474(21)US1814000041), US1814000043 ((01)00884838091474(21)US1814000043), US1814000044 ((01)00884838091474(21)US1814000044), US1814000045 ((01)00884838091474(21)US1814000045), US1814000046 ((01)00884838091474(21)US1814000046), US1814000047 ((01)00884838091474(21)US1814000047), US1814000048 ((01)00884838091474(21)US1814000048), US1814000049 ((01)00884838091474(21)US1814000049), US1814000050 ((01)00884838091474(21)US1814000050), US1814000051 ((01)00884838091474(21)US1814000051), US1814000052 ((01)00884838091474(21)US1814000052), US1814000053 ((01)00884838091474(21)US1814000053), US1814000054 ((01)00884838091474(21)US1814000054), US1814000055 ((01)00884838091474(21)US1814000055), US1814000056 ((01)00884838091474(21)US1814000056), US1814000058 ((01)00884838091474(21)US1814000058), US1814000059 ((01)00884838091474(21)US1814000059), US1814000060 ((01)00884838091474(21)US1814000060), US1814000061 ((01)00884838091474(21)US1814000061), US1814000062 ((01)00884838091474(21)US1814000062), US1814000063 ((01)00884838091474(21)US1814000063), US1814000064 ((01)00884838091474(21)US1814000064), US1814000065 ((01)00884838091474(21)US1814000065), US1814000066 ((01)00884838091474(21)US1814000066), US1814000067 ((01)00884838091474(21)US1814000067), US1814000068 ((01)00884838091474(21)US1814000068), US1814000069 ((01)00884838091474(21)US1814000069), US1814000070 ((01)00884838091474(21)US1814000070), US1814000072 ((01)00884838091474(21)US1814000072), US1814000074 ((01)00884838091474(21)US1814000074), US1814000078 ((01)00884838091474(21)US1814000078), US1814000081 ((01)00884838091474(21)US1814000081), US1814000082 ((01)00884838091474(21)US1814000082), US1814000083 ((01)00884838091474(21)US1814000083), US1814000084 ((01)00884838091474(21)US1814000084), US1814000085 ((01)00884838091474(21)US1814000085), US1814000086 ((01)00884838091474(21)US1814000086), US1814000087 ((01)00884838091474(21)US1814000087), US1814000088 ((01)00884838091474(21)US1814000088), US1814000089 ((01)00884838091474(21)US1814000089), US1814000092 ((01)00884838091474(21)US1814000092),  US1814000094 ((01)00884838091474(21)US1814000094), US1814000096 ((01)00884838091474(21)US1814000096).
Recalling firm:
Invivo Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.

ALL 50 STATES
▸Full report

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

Recall #:
83820
Lot/product code:
Lot number 2858, 2861, and 3749
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

ALL 50 STATES
▸Full report

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

Recall #:
83820
Lot/product code:
Lot numbers 91500604 and 91600017
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

ALL 50 STATES
▸Full report

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

Recall #:
83820
Lot/product code:
Lot numbers 3168, 3464, 3660, 3963, and 4216.
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

The epoxy on Apex manufactured epoxy-coated instruments can pop off.

ALL 50 STATES
▸Full report

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

Recall #:
83820
Lot/product code:
Lot number 91401455
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 28, 2018

TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.

The WHD/WHV impactors can rust over time due to an improper manufacturing process.

ALL 50 STATES
▸Full report

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

Recall #:
83820
Lot/product code:
Lot numbers 049045, 049044, and 049044R1.
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 2, 2018

Medtronic CareLink Encore 29901 Programmer

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

ALL 50 STATES
▸Full report

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

Recall #:
81300
Lot/product code:
All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 2, 2018

Medtronic CareLink 2090 Programmer

Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.

ALL 50 STATES
▸Full report

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

Recall #:
81300
Lot/product code:
All Serial Numbers
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 3, 2018

Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)

Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
81246
Lot/product code:
Serial Numbers NG1330099H NG1330154H NG1329859H NG1330107H NG1330110H NG1330113H NG1330122H NG1330133H NG1330136H NG1330140H NG1330142H NG1330143H NG1330145H NG1330160H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1330145H NG1330160H NG1330160H NG1330145H NG1330143H NG1330142H NG1330140H NG1330136H NG1330133H NG1330122H NG1330113H NG1330110H NG1330107H NG1329859H NG1399727H NG1399183H NG1399310H NG1400412H NG1399761H NG1399740H NG1399750H NG1400409H NG1400138H NG1400067H NG1400445H NG1400080H NG1400332H NG1400078H NG1400458H NG1400416H NG1400350H NG1400420H NG1400003H NG1399926H NG1400448H NG1400674H NG1400159H NG1399266H NG1400140H NG1400562H NG1400509H NG1400346H NG1399206H NG1400293H NG1400164H NG1399776H NG1399708H NG1399738H NG1400077H NG1399562H NG1399623H NG1399101H NG1399268H NG1398858H NG1399624H NG1399345H NG1399574H NG1399614H NG1398932H NG1398948H NG1399462H NG1399530H NG1399210H NG1399441H NG1399997H NG1400051H NG1400054H NG1400106H NG1400292H NG1399923H NG1400072H NG1399663H NG1399669H NG1400151H NG1400353H NG1400410H NG1400434H NG1399757H NG1399680H NG1399890H NG1399622H NG1399674H NG1399613H NG1399892H NG1399015H NG1399389H NG1399467H NG1398249H NG1398312H NG1399185H NG1398301H NG1399497H NG1398015H NG1398434H NG1398130H NG1398062H NG1398063H NG1399103H NG1399175H NG1399107H NG1399352H NG1399527H NG1399176H NG1399443H NG1399472H NG1399202H NG1399057H NG1399182H NG1399271H NG1398692H NG1398937H NG1398670H NG1398550H NG1398795H NG1398647H NG1398751H NG1398667H NG1398555H NG1398646H NG1400170H NG1400154H NG1400282H NG1400160H NG1400148H NG1400438H NG1400482H NG1399894H NG1400512H NG1400481H NG1398852H NG1400471H NG1400513H NG1400569H NG1400206H NG1400477H NG1400575H NG1400068H NG1400572H NG1400480H NG1400344H NG1400473H NG1400453H NG1397889H NG1397914H NG1398297H NG1397901H NG1399354H NG1399284H NG1399633H NG1399445H NG1399495H NG1399413H NG1399636H NG1399054H NG1399020H NG1399195H NG1399196H NG1398467H NG1394992H NG1399334H NG1398931H NG1399079H NG1399213H NG1398385H NG1399180H NG1398839H NG1399058H NG1398919H NG1399113H NG1399435H NG1399494H NG1399384H NG1398800H NG1398455H NG1398444H NG1398470H NG1398435H NG1398304H NG1398443H NG1399407H NG1398293H NG1399567H NG1398918H NG1399019H NG1399375H NG1399312H NG1399320H NG1398032H NG1399379H NG1399318H NG1398940H NG1399083H NG1399177H NG1399313H NG1399012H NG1399204H NG1399105H NG1398084H NG1398289H NG1399404H NG1398910H NG1398451H NG1399246H NG1399188H NG1398728H NG1398237H NG1399056H NG1398832H NG1399021H NG1399569H NG1398439H NG1398502H NG1399263H NG1398475H NG1399564H NG1399016H NG1399416H NG1399095H NG1398936H NG1399339H NG1398305H NG1398433H NG1399186H NG1399256H NG1398650H NG1398663H NG1399707H NG1399615H NG1398464H NG1399244H NG1399218H NG1399080H NG1399013H NG1398553H NG1398569H NG1398563H NG1399084H NG1399474H NG1398941H NG1398909H NG1399250H NG1399051H NG1398915H NG1398837H NG1398817H NG1398857H NG1399565H NG1399248H NG1398928H NG1399323H NG1399216H NG1399259H NG1399634H NG1398916H NG1398924H NG1399629H NG1399748H NG1398828H NG1399491H NG1399448H NG1399492H NG1398759H NG1399452H NG1399252H NG1399401H NG1399575H NG1399187H NG1398694H NG1398677H NG1398544H NG1399332H NG1398673H NG1399091H NG1399576H NG1398792H NG1399418H NG1399017H NG1399100H NG1399493H NG1399289H NG1398438H NG1398763H NG1399050H NG1399208H NG1398860H NG1399225H NG1398652H NG1398686H NG1398691H NG1398651H NG1398695H NG1398566H NG1398515H NG1399692H NG1404598H NG1404947H NG1404897H NG1404932H NG1405462H NG1405014H NG1405246H NG1405244H NG1405377H NG1404732H NG1400167H NG1399671H NG1399925H NG1399916H NG1399991H NG1400050H NG1399928H NG1400411H NG1400045H NG1400172H NG1400446H NG1400162H NG1399743H NG1400284H NG1400046H NG1400042H NG1400436H NG1400005H NG1400287H NG1400424H NG1399993H NG1400312H NG1399184H NG1399709H NG1399573H NG1399885H NG1399566H NG1399934H NG1399999H NG1405228H NG1404682H NG1405263H NG1405242H NG1404756H NG1404895H NG1404726H NG1404617H NG1404728H NG1405042H NG1404520H NG1404892H NG1404625H NG1404938H NG1405510H NG1404785H NG1404944H NG1405291H NG1404940H NG1405223H NG1405190H NG1405248H NG1405285H NG1405229H NG1404840H NG1404879H NG1405261H NG1404655H NG1405376H NG1405237H NG1405293H NG1404965H NG1405450H NG1404687H NG1404953H NG1404823H NG1405232H NG1405257H NG1404731H NG1404700H NG1399719H NG1400070H NG1399882H NG1399617H NG1399621H NG1399714H NG1399777H NG1398793H NG1399759H NG1398649H NG1398917H NG1398853H NG1399090H NG1398834H NG1401004H NG1400737H NG1401014H NG1401012H NG1401016H NG1400701H NG1394712H NG1343244H NG1398802H NG1394999H NG1343246H NG1343253H NG1394985H NG1343249H NG1394967H NG1400682H NG1405554H NG1405378H NG1398812H NG1398738H NG1399053H NG1400734H NG1395001H NG1394982H NG1394997H NG1400546H NG1399342H NG1400063H NG1400044H NG1399896H NG1399905H NG1399198H NG1399178H NG1399659H NG1399898H NG1398863H NG1400064H NG1399772H NG1400069H NG1399316H NG1399631H NG1399918H NG… (truncated, 1638277 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)