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Recalls affecting Oklahoma

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

16,606 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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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2017

Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures

Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

ALL 50 STATES
▸Full report

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

Recall #:
77801
Lot/product code:
Lot Numbers: 507830, 871270, 959670
Recalling firm:
Encore Medical, Lp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 26, 2017

Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures

Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

ALL 50 STATES
▸Full report

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

Recall #:
77801
Lot/product code:
Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700
Recalling firm:
Encore Medical, Lp
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 30, 2017

Heron toilet and bath chair Model 880505-01 & 880505-11

Replacement campaign on all units that have a gas spring head in aluminum.

ALL 50 STATES
▸Full report

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

Recall #:
81217
Lot/product code:
Serial Numbers: 309658, 310007, 319209, 319822, 319823, 319824, 319825, 319826, 319827, 319829, 319830, 319831, 330695, 330696, 330697, 331862, 331914, 332387, 332586, 332587, 332589, 333755, 333761, 333762, 334833, 342515, 342518, 342523, 345084, 345085
Recalling firm:
R82 A/S
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 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 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 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 Nice Station Light Based 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 Nice Station Light Based 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 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 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 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 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 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 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, 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, 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 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, 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, 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 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.

ALL 50 STATES
▸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 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.

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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.
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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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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
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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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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)