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Recalls affecting Maryland

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

16,826 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 Mendietary 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 AliveMoringa 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. Braun0.9% 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 ValueOrganic 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

LipofitLipofit 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

KofinasGarlic 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 TemptationsChocolatey 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 SproutsRobust 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

MartinaMangoes

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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled August 15, 2018

TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.

The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

ALL 50 STATES
Full report

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

Recall #:
83984
Lot/product code:
Lot # 110631.
Recalling firm:
TriMed Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1142-2018
Lot/product code:
Batch: BBY1E001, BBY1E003, BBY1C002, BBY1E002, BBY1D001
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1139-2018
Lot/product code:
Batch: BV65D002, BV65C002, BV65C003, BV65C004, BV65D001
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1143-2018
Lot/product code:
Batch: BBY2E001, BBY2D001, BBY2D002
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1137-2018
Lot/product code:
Batch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1135-2018
Lot/product code:
Batch: BV47C005, BV47C006, BV47D001, BV47C003, BV47C004
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1140-2018
Lot/product code:
Batch: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, BV53C005
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1141-2018
Lot/product code:
Batch: BBX2D025, BBX2D026, BBX2E001, BBX2E002, BBX2E003, BBX2E004, BBX2E005, BBX2D003, BBX2D004, BBX2D005, BBX2D006, BBX2D007, BBX2D008, BBX2D015, BBX2D016, BBX2D017, BBX2D018, BBX2D019, BBX2D020, BBX2D021, BBX2D022, BBX2D023, BBX2D024, BBX2D001, BBX2D002, BBX2D009, BBX2D010, BBX2D011, BBX2D012, BBX2D013, BBX2D014, BBX2C007
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1134-2018
Lot/product code:
Batch: BV46C007, BV46C008, BV46C009, BV46C010, BV46C011, BV46C012, BV46C003, BV46C006
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1144-2018
Lot/product code:
Batch: BBX9D004, BBX9E001, BBX9D001, BBX9D002, BBX9D003
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1138-2018
Lot/product code:
Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1136-2018
Lot/product code:
Batch: BV48D001, BV48D002
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 17, 2018

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-1145-2018
Lot/product code:
Batch: BBY4D004, BBY4E001, BBY4D001, BBY4D002, BBY4D003
Recalling firm:
Torrent Pharma Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 21, 2018

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

ALL 50 STATES
Full report

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

Recall #:
80996
Lot/product code:
Serial Numbers: 5214432, 5214445
Recalling firm:
Exactech, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2018

Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.

The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.

ALL 50 STATES
Full report

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

Recall #:
81106
Lot/product code:
UDI Number 0888867223349; Material Number AR-400UBH;   Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435
Recalling firm:
Arthrex, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 31, 2018

Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
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 August 31, 2018

Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
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 August 31, 2018

Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
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 August 31, 2018

Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
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 August 31, 2018

Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
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 August 31, 2018

Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

ALL 50 STATES
Full report

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

Recall #:
81058
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 4, 2018

GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 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), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

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: SJA15150092HA SJA15150100HA SJA15150124HA SJA15150125HA SJA15150126HA SJA15150127HA SJA15150128HA SJA15150139HA SJA15170033HA SJA15170079HA SJA15170081HA SJA15170085HA SJA15170086HA SJA15170087HA SJA15170088HA SJA15170089HA SJA15170090HA SJA15170091HA SNE16060190HA SNE16110218HA SJA14127613HA SJA14127614HA SJA15262026HA SJA15262173HA SJA15272036HA SJA15282008HA SJA15282009HA SJA15282010HA SJA15282014HA SJA15282015HA SJA15282016HA SJA15282017HA SJA15282019HA SJA15282022HA SJA15282024HA SJA15282043HA SJA15282044HA SJA15282048HA SJA15282051HA SJA15282054HA SJA15282055HA SJA15282059HA SJA15282060HA SJA15282063HA SJA15282065HA SJA15282118HA SJA15282122HA SJA15282125HA SJA15282128HA SJA15282129HA SJA15282131HA SJA15282134HA SJA15282135HA SJA15282141HA SJA15282149HA SJA15382048HA SJA14437335HA SJA14437337HA SJA14127619HA SJA14127621HA SJA14127622HA SJA14127623HA SJA14127624HA SJA14127626HA SJA14392398HA SJA14392402HA SJA14192489HR SJA14302513HR SJA15401023HR SJA15170060HA SJA15170127HA SJA15170128HA SJA15170129HA SJA15170130HA SJA15170137HA SJA15292063HA SJA14473730HA SNE15480016HA SNE15480017HA SNE15480019HA SNE15511032HA SJA15342151HA SJA15342152HA SJA15252097HA SJA15252142HA SJA15252143HA SJA15252144HA SJA15252149HA SJA15252150HA SJA15252151HA SJA15262060HA SJA15262061HA SJA15262062HA SJA15262063HA SJA15262064HA SJA15262068HA SJA15262069HA SJA15262070HA SJA15452019HA SNE15431001HA SNE16010064HA SNE16010070HA SNE16010071HA SNE16010078HA SNE16010079HA SNE16010080HA SJA15262004HA SJA15262005HA SJA14403421HA SJA15101137HA SNE16110060HA SNE16110063HA SNE16110065HA SNE16110066HA SJA15262006HA SNE16080111HA SNE16080112HA SNE16080113HA SNE16080114HA SNE16080115HA SNE16080116HA SNE16080117HA SNE16080118HA SNE16080119HA SNE16080121HA SNE16050129HA SNE16050131HA SNE16120029HR SNE16120040HR SNE15520017HA SNE15520018HA SNE15520019HA SNE15520020HA SNE15520022HA SNE15531045HA SNE15531046HA SNE16010075HA SNE16010076HA SNE16010077HA SNE15520036HA SNE15520079HA SNE15520080HA SNE16080202HA SNE16080203HA SNE16080204HA SNE16080206HA SNE16080207HA SNE16090021HA SNE16090022HA SNE16090024HA SNE16090025HA SNE16090027HA SNE16090029HA SNE16090031HA SNE16090032HA SNE16130019HA SNE16130020HA SNE16130023HA SNE16130024HA SJA14138552HA SJA14138553HA SJA14138555HA SJA14138558HA SJA15120117HA SJA15120146HA SJA15120147HA SJA15120148HA SJA15120149HA SJA15120150HA SJA15120151HA SJA15120152HA SJA15120154HA SJA15120155HA SJA15120156HA SJA15120157HA SJA15120161HA SJA15120164HA SJA15120165HA SJA15120166HA SJA15120168HA SJA15140138HA SJA15140139HA SJA15140140HA SJA15140141HA SJA15140145HA SJA15140146HA SJA15140147HA SJA15140148HA SJA15101204HA SJA15101207HA SJA15101221HA SJA15101224HA SJA15101235HA SJA15101240HA SJA15101243HA SJA15121009HA SJA15044565HA SJA15044566HA SJA15044567HA SJA15044569HA SJA15044571HA SJA15101292HA SJA15101293HA SJA15112630HA SJA15112631HA SJA15112632HA SJA15112633HA SJA15112635HA SJA15112636HA SJA15112637HA SJA15112638HA SJA15112639HA SJA15112640HA SJA15170076HA SJA15066575HA SJA15066586HA SJA15066599HA SJA15066600HA SNE16121015HA SJA13507992HR SJA14415427HR SNE16191082HR SJA15222023HA SNE16090200HA SJA14358266HA SJA14358267HA SJA14379900HA SJA14379901HA SJA14472381HA SJA15302035HA SJA15302041HA SJA14403455HA SJA14403456HA SJA15031768HA SJA15031818HA SJA15031819HA SJA15033243HA SJA15033244HA SJA15033245HA SJA15066593HA SJA15090664HA SJA15090665HA SJA15090675HA SNE15450027HA SNE15450028HA SNE15450029HA SJA14460951HA SJA14460973HA SNE17251032HA SJA15382323HA SJA14414517HA SJA15020681HA SJA15322125HA SJA15322131HA SJA15332114HA SJA15332124HA SJA15332138HA SJA15332139HA SJA15332141HA SJA15332142HA SJA15332143HA SJA15332144HA SJA15332145HA SJA15332149HA SJA15332150HA SJA15332151HA SJA14291680HA SJA15171001HA SJA15171002HA SJA15171003HA SJA15171005HA SJA15171006HA SJA15291004HA SNE15511001HA SNE15511004HA SNE15511008HA SNE15511014HA SNE16021001HA SNE16021002HA SJA13507985HA SJA13508793HA SJA13508794HA SJA13508795HA SJA13019537HA SJA13508792HA SJA13508796HA SJA13508797HA SJA14314410HA SNE16110126HA SNE15490001HA SNE15490034HA SNE15490070HA SNE15520077HA SNE15520078HA SNE15520088HA SNE15520089HA SNE15520090HA SJA14459942HA SJA14507676HA SJA14507679HA SJA14507680HA SJA14507691HA SJA14507692HA SJA14507703HA SJA14507704HA SJA14519037HA SJA14519039HA SJA14519041HA SJA14519042HA SJA14519043HA SJA14519045HA SJA14519046HA SJA14519048HA SNE15511016HA SNE15531064HA SJA13519474HR SNE16181001HR SNE16181014HR SNE16181029HR SNE16181033HR SNE16181035HR SNE16181041HR SNE16181042HR SNE16181047HR SNE16181048HR SNE16181054HR SNE16181056HR SNE16181059HR SNE16181061HR SNE16181062HR SNE16181070HR SNE16191003HR SNE16191008HR SNE16191010HR SNE16191015HR SNE16191016HR SNE16191017HR SNE16191028HR SNE16191029HR SNE16191055HR SNE16191068HR SNE16191071HR SNE16191073HR SNE16191076HR SNE16191078HR SJA14381877HA SJA14381881HA SJA14381885HA SJA14392419HA SJA14392420HA SJA14392421HA SJA14392422HA SJA14392423HA SJA14392424HA SJA14392425HA SJA143… (truncated, 2210545 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 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

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 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)