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Recalls affecting Colorado

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

16,771 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

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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/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

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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/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

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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)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced 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)
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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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2017

Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers

The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

ALL 50 STATES
▸Full report

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

Recall #:
79697
Lot/product code:
Model APOLLO 1V+Medical Platform
Recalling firm:
Beijing Syntech Laser Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2017

Beijing Syntech Laser UL Station surgical lasers

The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

ALL 50 STATES
▸Full report

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

Recall #:
79697
Lot/product code:
Model UL Station
Recalling firm:
Beijing Syntech Laser Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2017

Beijing Syntech Laser Diode Laser surgical lasers

The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

ALL 50 STATES
▸Full report

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

Recall #:
79697
Lot/product code:
Model Diode Laser
Recalling firm:
Beijing Syntech Laser Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2017

Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers

The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

ALL 50 STATES
▸Full report

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

Recall #:
79697
Lot/product code:
Model Trixel 11 C02 Laser
Recalling firm:
Beijing Syntech Laser Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2017

Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers

The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

ALL 50 STATES
▸Full report

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

Recall #:
79697
Lot/product code:
Model Apollo V + Medical Platform
Recalling firm:
Beijing Syntech Laser Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2017

Beijing Syntech Laser UL C02 Laser surgical lasers

The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

ALL 50 STATES
▸Full report

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

Recall #:
79697
Lot/product code:
Model UL C02 Laser
Recalling firm:
Beijing Syntech Laser Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 3, 2017

Beijing Syntech Laser Trixel C02 Laser surgical lasers

The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".

ALL 50 STATES
▸Full report

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

Recall #:
79697
Lot/product code:
Model Trixel C02 Laser
Recalling firm:
Beijing Syntech Laser Co., Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2017

CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.

ALL 50 STATES
▸Full report

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

Recall #:
77877
Lot/product code:
0998-XX-3013-XX; 0998-UC-3013-XX
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2017

CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.

ALL 50 STATES
▸Full report

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

Recall #:
77877
Lot/product code:
0998-UC-0446HXX; 0998-UC-0479HXX
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2017

CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.

ALL 50 STATES
▸Full report

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

Recall #:
77877
Lot/product code:
0998-XX-3023-XX; 0998-UC-3023-XX
Recalling firm:
Maquet Datascope Corp - Cardiac Assist Division
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 24, 2017

Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.

Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.

ALL 50 STATES
▸Full report

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

Recall #:
80583
Lot/product code:
Product Number 89140.0105, Lot Number 4500197481
Recalling firm:
Richard Wolf GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2017

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
79075
Lot/product code:
UDI 10884521706590, Lot codes: S6MG006PX,S6MG009PX,S6MG013PX,S6MG020PX,S7AG011X,S7AG012X,S7BG008X,S7CG003X,S7DG003X,S7DG009X,S7FG001X,S7FG002X,S7FG005X,S7FG008X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2017

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
79075
Lot/product code:
UDI 10884521189553, Lot codes: S5LG004PX,S6AG001X,S6BG002X,S6BG005X,S6BG016PX,S6CG003X,S6CG005X,S6CG017X,S6DG004X,S6EG001X,S6FG001X,S6FG006X,S6FG010X,S6KG002X,S6KG006PRX,S6KG006PX,S6LG004X,S6MG002X,S7CG001PCX,S7CG011PCX,S7CG015CX,S7EG001X,S7EG003X,S7FG011PX
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2017

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
79075
Lot/product code:
UDI 10884521706583, Lot codes: S6MG005PX,S6MG008PX,S6MG012PX,S6MG019PX,S7AG001PX,S7AG006X,S7AG010X,S7AG013X,S7BG001X,S7BG003X,S7BG007X,S7BG013X,S7CG002X,S7CG005X,S7CG007X,S7CG013X,S7EG009X,S7FG003X,S7FG004X,S7FG007X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2017

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
79075
Lot/product code:
UDI 10884521189546, Lot codes: S5LG003PX,S5MG016PX,S5MG018PX,S6AG004X,S6AG005X,S6AG007X,S6BG004X,S6BG011X,S6BG015PX,S6BG017X,S6CG002X,S6CG008X,S6CG014X,S6CG015X,S6CG016X,S6DG002X,S6DG005X,S6DG007X,S6DG010X,S6EG004X,S6EG006X,S6EG008X,S6FG005X,S6FG008X,S6GG007X,S6GG010X,S6HG001X,S6HG003PX,S6HG008PX,S6HG009PX,S6HG012X,S6JG001X,S6KG003X,S6KG005PRX,S6KG005PX,S6KG009X,S6KG016X,S6LG002X,S6MG003X,S6MG018X,S7AG003X,S7BG012PCX,S7CG004X,S7CG006X,S7CG008PCX,S7CG010PCX,S7CG017X,S7DG002X,S7DG005X,S7EG006X,S7FG010PX
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2017

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
79075
Lot/product code:
UDI 10884521189539, Lots S5LG002PX,S5MG004PX,S5MG009PX,S5MG010PX,S5MG013PX,S5MG017PX,S5MG019PX,S6AG002X,S6AG003X,S6AG006X,S6AG009X,S6AG010X,S6BG001X,S6BG006X,S6BG012X,S6BG013X,S6BG014PX,S6CG001X,S6CG004X,S6CG006X,S6CG007X,S6CG009X,S6CG013X,S6CG018X,S6CG019X,S6DG001X,S6DG003X,S6DG006X,S6DG008X,S6DG009X,S6EG002X,S6EG003X,S6EG005X,S6EG007X,S6EG010X,S6FG002X,S6FG003X,S6FG004X,S6FG009X,S6GG004X,S6GG005X,S6GG006X,S6GG008X,S6GG009X,S6GG011X,S6GG012X,S6GG015X,S6HG002X,S6HG010X,S6HG011X,S6HG013X,S6KG001X,S6KG004PRX,S6KG004PX,S6KG007X,S6KG008X,S6KG010X,S6KG014X,S6KG015X,S6KG017X,S6LG001X,S6LG003X,S6LG005X,S6LG006X,S6LG008X,S6LG009X,S6LG010X,S6MG001X,S6MG004X,S6MG017X,S7AG004X,S7BG002X,S7BG011PCX,S7CG009PCX,S7CG012PCX,S7CG016X,S7DG001X,S7DG006X,S7EG002X,S7EG004X,S7EG005X,S7FG009PX,S7GG001X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 7, 2017

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

ALL 50 STATES
▸Full report

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

Recall #:
79075
Lot/product code:
UDI 10884521706606, Lot codes: S6MG007PX,S6MG010PX,S6MG016PX,S7AG002PX,S7BG005X,S7BG009X,S7DG004X,S7FG006X
Recalling firm:
Covidien LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2017

Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.

ALL 50 STATES
▸Full report

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

Recall #:
77987
Lot/product code:
All Alaris Pump module model 8100 manufactured and serviced with the bezel assembly manufactured between October 2011 and November 2011; Serial Numbers - Serial 13537720 13537735 13538005 13538811 13540340 13541935 13543108 13543503 13543666 13544201 13544350 13545092 13545892 13546315 13546638 13548091 13550608 13550614 13550629 13550670 13552666 13552667 13552781 13552782 13553628 13553661 13553714 13553730 13553739 13554035 12851369 12851850 9879510 9879561 9880323 9880838 9881158 12564799 13157405 13563286 13566911 13566932 13566933 13567118 13585121 13585213 13585493 13586248 13586314 13586329 13586339 13586340 13586408 13586578 13586723 13586731 13586733 13586738 13586746 13586758 13586763 13586764 13586768 13586775 13586782 13586784 13586793 13586795 13586797 13586798 13586819 13586820 13586835 13586836 13586839 13586855 13586860 13586877 13586878 13586898 13586952 13586957 13586960 13586967 13586976 13587076 13587077 13587118 13587220 13587231 13587232 13587233 13587262 13587263 13587266 13587289 13587290 13587291 13587297 13587312 13587315 13587345 13587398 13196293 13203541 13207333 13213463 13214795 13217554 13219137 13219971 13375015 13375617 13375737 12471635 9857470 9858862 9858865 9859690 9860106 9860746 13184877 13186091 13582527 13582709 13599442 12460530 12474814 12771113 13619912 13620162 13585671 13566067 13616956 13545222 13545224 13545250 13545260 13545262 13550278 13550317 13550318 13550319 13550325 13550337 13550365 13550369 13550370 13550379 13553239 13549816 13549832 13549886 13549901 13549903 13550267 13550271 13550339 13550340 13550345 13550346 13550355 13550356 13550357 13550366 13553126 13553134 13553403 13553415 13568914 13568950 13569155 13569179 13569248 13569694 13569829 13569830 13569838 13569839 13569854 13569876 13569947 13569948 13569953 13569955 13569957 13570013 13570014 13570015 13570017 13570022 13570023 13570052 13570063 13570076 13570077 13570127 13570128 13570137 13570138 13570168 13570184 13570198 13570222 13570236 13570249 13570255 13570256 13570263 12518795 12520618 12520990 13139496 13152562 13153423 13550976 13605208 13605881 13605956 13620375 13620540 13620587 13620902 13620923 13552790 13556036 13556048 13556052 13556056 13558162 13558197 13558234 13142008 13142059 13142277 13142311 13550252 13552900 13552901 13554258 13554809 13554826 13554865 13554878 13554887 13555000 13555023 13036704 4130472 13551713 13551714 13551715 13551750 13552281 13122441 13606144 13606620 13606680 13606687 12652922 13551874 13554663 13555012 13555162 13555172 13555189 13555277 13555711 13555714 13555740 13555743 13562785 13562126 13562559 13566817 13566828 13566873 13618695 13618974 13620108 13620109 13623007 13626334 4049223 12389924 12390048 12390059 12390063 12390110 12421349 13410265 13481070 13415581 13415684 13546628 13546711 13550790 13550951 9895104 12548328 12366930 12367649 12367659 12367775 12367815 12368485 13550687 13550967 13537121 13537307 13537615 13537708 13537929 13538004 13538163 13538907 13539151 13539520 13539841 13539844 13540113 13540190 13540375 13540560 13540586 13541136 13541300 13541571 13541863 13541874 13542038 13542061 13542222 13542379 13542436 13542446 13542474 13542525 13542684 13542888 13542903 13542957 13542989 13543284 13543448 13543508 13543610 13543667 13543668 13543746 13543917 13544255 13544355 13545718 13546268 13546294 13546518 13546684 13546696 13546821 13547115 13547166 13547222 13547288 13547340 13547345 13547378 13547382 13547407 13547413 13547427 13547530 13547563 13548096 13548131 13548135 13548173 13548309 13548311 13548425 13548455 13549072 13549099 13549100 13549225 13549229 13549244 13549258 13549279 13549285 13549314 13549315 13549319 13549324 13549328 13549939 13549974 13549992 13549996 13550004 13550008 13550033 13550039 13550048 13550054 13550058 13550068 13550076 13550078 13550081 13550087 13550102 13550107 13550113 13550127 13550131 13550134 13550136 13550138 13550141 13550146 13550147 13550149 13550150 13550151 13550152 13550153 13550164 13550165 13550168 13550171 13550175 13550178 13550180 13550212 13550224 13550230 13550232 13550235 13550635 13550654 13550673 13550678 13550684 13550697 13550706 13550707 13550725 13550728 13550729 13550732 13550742 13550750 13550751 13550753 13550774 13550776 13550787 4071770 4072996 13582245 13582462 13582640 13582680 4107349 12340716 13571569 13571727 13571729 13571749 13571770 13571812 13571813 13571820 13571828 13571848 13571854 13571856 13571878 13571894 13571917 13571923 13571930 13571951 13572147 13572149 13572183 13572202 13572205 13572211 13572212 13572214 13572226 13572229 13572241 13572249 13556663 13556669 13556672 13556673 13556683 13574132 13576370 13587807 13612188 13616914 13617837 13618602 13619396 13619872 13619896 13619956 13620006 13620357 13620552 13621706 13621787 13621968 13622945 13623052 13623339 13623429 13623619 13623843 13623879 13623889 13624255 13624679 13624798 13624859 13625544 13626012 13626042 13626134 13626210 13626383 13626599 13626685 13627074 13627… (truncated, 253700 characters total — see the official FDA record for the full value)
Recalling firm:
CareFusion 303, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 9, 2017

Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).

Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.

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▸Full report

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

Recall #:
78609
Lot/product code:
US: CFN #: GTIN: PIN: 8637-20 00643169508149 863702012H 8637-40 00643169508156 863704012H OUS: CFN#: GTIN : PIN: 8637-20 00643169700901 863700221K 8637-20 00643169700918 863700222K 8637-20 00643169700925 863700223K 8637-20 00643169700932 863700224K 8637-20 00643169700949 863700225K 8637-20 00643169700956 863700226K 8637-20 00643169700963 863700227K 8637-20 00643169700970 863700228K 8637-20 00643169700987 863700229K 8637-20 00643169700994 863700230K 8637-20 00643169732247 863700241K 8637-20 00643169732254 863700242K 8637-20 00643169732261 863700243K 8637-20 00643169732278 863700244K 8637-20 00643169732285 863700245K 8637-20 00643169732292 863700246K 8637-20 00643169732308 863700247K 8637-20 00643169732315 863700248K 8637-20 00643169732322 863700249K 8637-20 00643169732339 863700250K 8637-40 00643169701007 863700231K 8637-40 00643169701014 863700232K 8637-40 00643169701021 863700233K 8637-40 00643169701038 863700234K 8637-40 00643169701045 863700235K 8637-40 00643169701052 863700236K 8637-40 00643169701069 863700237K 8637-40 00643169701076 863700238K 8637-40 00643169701083 863700239K 8637-40 00643169701090 863700240K 8637-40 00643169732346 863700251K 8637-40 00643169732353 863700252K 8637-40 00643169732360 863700253K 8637-40 00643169732377 863700254K 8637-40 00643169732384 863700255K 8637-40 00643169732391 863700256K 8637-40 00643169732407 863700257K 8637-40 00643169732414 863700258K 8637-40 00643169732421 863700259K 8637-40 00643169732438 863700260K
Recalling firm:
Medtronic Neuromodulation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 23, 2017

IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.

Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors

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▸Full report

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

Recall #:
78736
Lot/product code:
Model #: M300IA/AL, M3002A, M8102A, M8105A with ECO FW revision E.0 1.22 and 12-lead option C#12 Lots #s included on Consignee list  Catalog #: 862442 (M3001A), 866462 (M3001AL), 865039 (M3002A), 865040 (M8102A), 865024 (M8105A)
Recalling firm:
Philips Electronics North America Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2017

Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers

There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I) result and the PLT-F result. In most cases, the falsely decreased PLT-F results display a PLT Abn Scattergram message with an asterisk beside the result or an Action Message: Difference between PLT and PLT- F. Check the results. These are indicators of unreliable data. In rare instances, platelet flags may be absent. The PLT-I results are unaffected.

ALL 50 STATES
▸Full report

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

Recall #:
78134
Lot/product code:
Lot Numbers: A6051 A6052 A6053 A6054 A6055 A6056 A6057 A6058 A6059 A6060 A6061 A6062 A6063 A6064 A6065 A6066 A6067 A6068 A6069 A6070 A6071 A6072 A6073 A6074 A6075 A6076 A6077 A6078 A6079 A6080 A6081 A6082 A6083 A6084 A6085 A6086 A6087 A6088 A6089 A6090
Recalling firm:
Sysmex America, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 8, 2017

Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System

An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.

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▸Full report

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

Recall #:
78109
Lot/product code:
Lot # 15AG0HJ, 15AG0HQ, 15AG0UY, 15AG00P, 15AG040, 15AG08Y, 14AG243, 15AG00Q, 15AG0UZ, 15AG0V0, 15AG0HN, 16AG02J
Recalling firm:
Limacorporate S.p.A
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2017

Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

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▸Full report

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

Recall #:
78125
Lot/product code:
Lot Numbers: 6211649, 6207537
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2017

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

ALL 50 STATES
▸Full report

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

Recall #:
78125
Lot/product code:
Lot Numbers: 5179979 5182542 5185471 5187173 5188894 5189581 5191349 5192467 5178077 5189588 5181137 5181140 5184757 5184758 5186199 5186203 5188890 5191350 5193510 5186206 5179854 5179857 5179975 5181712 5182176 5182543 5183121 5185154 5185157 5186200 5186201 5186202 5187102 5187170 5188889 5188893 5190033 5190708 5190710 5191351 5192470 5192679 5194101 5168207 5189592 5175824 5176442 5179855 5179977 5181711 5181713 5182177 5182179 5182544 5183122 5183123 5184087 5185155 5185156 5187101 5187171 5187817 5188886 5188887 5188888 5188895 5189583 5189584 5189585 5189586 5190031 5190707 5190709 5192468 5192469 5192471 5192680 5192691 5192692 5193308 5194100 5178081 5185473 5186207 5187821 5189590 5191354 5178084 5183072 5185153 5187103 5187818 5187819 5187820 5188892 5193505 5178076 5189591 5175953 5181138 5185472 5187172 5191352 5192682 5186205 5181139 5186204 5189587
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 10, 2017

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

ALL 50 STATES
▸Full report

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

Recall #:
78125
Lot/product code:
Lot Numbers: 5179671 5179672 5179675 5179676 5179678 5179680 5174468 5174471 5185640 5185642 5185643 5185645 5185647 5185648 5185650 5176067 5176070 5176073 5176074 5176079 5176082 5176085 5185660 5185663 5185666 5185669 5185672 5185673 5176224 5176050 5176052 5176054 5176056 5189836 5189838 5189839 5173751 5173752 5189378 5189379 5189380 5174455 5174457 5174459 5174461 5189358 5189359 5189362 5189364 5189366 5185736 5174481 5174483 5174485 5174487 5189386 5189388 5189390 5189392 5189394 5189395 5179685 5179686 5179687 5179688 5179689 5170715 5170823 5170825 5170827 5173463 5174300 5173470 5173471 5173472 5173473 5173474 5173475 5173476 5173477 5170133 5170134 5170135 5179710 5179711 5179712 5179713 5179714 5179715 5179716 5179717 5179718 5179719 5179720 5179721 5179722 5179723 5179724 5179725 5179726 5179727 5179728 5170153 5170154 5170155 5179690 5179691 5179692 5179693 5179694 5179695 5179696 5179697 5179698 5179699 5179700 5179701 5179702 5179703 5179704 5179705 5175939 5175940 5176014 5176015 5176016 5176017 5176018 5176019 5176020 5176021 5176022 5176023 5176024 5176025 5180499 5180500 5180501 5180502 5180503 5180504 5180505 5180506 5180507 5180508 5180509 5180510 5180511 5180512 5180513 5180514 5180515 5180516 5180517 5180518 5185600 5185601 5185602 5185603 5185604 5185605 5185606 5185607 5185608 5185609 5185610 5185611 5185612 5185613 5185614 5185615 5185616 5185617 5185618 5185619 5188097 5188098 5188099 5188100 5188101 5188102 5188103 5188104 5188105 5188106 5188107 5188108 5188109 5188110 5188111 5188112 5188113 5188114 5188115 5189846 5189847 5189852 5189853 5171629 5171630 5171631 5171632 5171633 5171634 5171635 5171636 5171637 5171638 5171639 5171640 5171641 5171642 5171643 5171644 5171645 5171646 5171647 5171648 5176026 5176027 5176028 5176029 5176030 5176031 5176032 5176033 5176034 5176035 5176036 5176037 5176038 5176039 5176040 5176041 5176042 5176043 5176044 5176045 5179790 5179791 5179792 5179793 5179794 5179795 5179796 5179797 5179798 5179799 5179800 5179801 5179802 5179803 5179804 5179805 5179806 5179807 5179808 5179809 5179810 5179811 5179812 5179813 5179814 5179815 5179816 5179817 5179818 5179819 5180479 5180480 5180481 5180485 5179758 5179759 5179760 5179761 5179762 5179763 5179764 5179765 5179766 5179767 5179768 5179769 5179770 5179771 5179772 5179773 5179774 5179775 5179776 5179777 5179778 5179779 5179780 5179781 5179782 5179783 5179784 5179785 5179786 5179787 5179788 5179789 5185620 5185621 5185622 5185623 5185624 5185625 5185626 5185627 5185628 5185629 5185630 5185631 5185632 5185633 5185634 5185635 5185636 5185637 5185638 5185639 5189406 5189407 5189408 5189409 5189410 5189411 5189412 5189413 5189414 5189415 5189416 5189417 5189418 5189419 5189420 5189421 5189422 5189423 5189424 5189425 5189426 5189427 5189428 5189429 5189430 5189431 5195705 5181716 5181718 5181720 5181722 5181723 5189446 5189449 5189451 5189452 5180519 5180522 5180525 5180528 5180530 5180531 5180533 5170898 5170901 5170904 5182140 5182143 5182145 5182146 5182149 5170619 5170622 5182158 5182161 5182163 5182164 5182166 5182167 5165412 5182139 5188235 5173794 5173795 5173796 5173797 5173798 5173799 5173800 5173801 5173802 5173803 5173804 5173805 5173806 5173807 5173808 5173809 5173810 5173811 5173812 5173813 5173814 5173815 5173816 5173817 5173818 5173819 5173820 5173821 5173822 5173823 5173824 5173825 5173826 5173827 5173828 5173829 5173830 5173831 5173832 5180451 5180452 5180453 5180454 5180455 5180456 5180457 5180458 5180459 5180460 5180461 5180462 5180463 5180464 5180465 5180466 5180467 5180468 5180469 5180470 5185480 5185481 5170855 5170856 5170857 5170858 5173753 5173754 5173755 5173756 5173757 5173758 5173759 5173760 5173761 5173762 5173763 5173764 5173765 5173766 5173767 5173768 5173769 5173770 5173771 5173772 5173773 5173774 5173775 5173776 5173777 5173778 5173779 5173780 5173781 5173782 5173783 5173784 5173785 5173786 5173787 5173788 5173789 5175967 5175968 5175969 5175970 5175971 5175972 5175973 5175974 5175975 5175976 5175977 5175978 5175979 5175980 5175981 5175982 5175983 5175984 5175985 5185590 5185591 5185592 5185593 5185594 5185595 5185596 5185597 5185598 5185599 5190564 5190565 5175947 5175948 5175950 5175951 5189466
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)