BIGNOPE
Ko-fi

Recalls affecting Hawaii

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

16,268 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
Class IIModerate risk
DrugRecalled December 31, 2018

Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0363-2019
Lot/product code:
Lot # VMSA17012-A, exp. date 11/2019 Lot # VMSA17013-A, exp. date 11/2019 Lot # VMSA17014-A, exp. date 11/2019 Lot # VMSA17015-A, exp. date 11/2019 Lot # VMSA17016-A, exp. date 11/2019 Lot # VMSA17017-A, exp. date 11/2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0366-2019
Lot/product code:
Lot # HTSA17033-A, exp. date 10/2020 Lot # HTSA17034-A, exp. date 10/2020 Lot # HTSA17035-A, exp. date 10/2020 Lot # HTSA17036-A, exp. date 10/2020 Lot # HTSA17040-A, exp. date 10/2020 Lot # HTSA17041-A, exp. date 11/2020 Lot # HTSA17042-A, exp. date 11/2020 Lot # HTSA17043-A, exp. date 11/2020 Lot # HTSA17037-A, exp. date 10/2020 Lot # HTSA17039-A, exp. date 10/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the 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-1035-2019
Lot/product code:
Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the 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-1039-2019
Lot/product code:
Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0368-2019
Lot/product code:
Lot # HVSA17011-A, exp. date 11/2020 Lot # HVSA17012-A, exp. date 11/2020 Lot # HVSA18001-A, exp. date 12/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0361-2019
Lot/product code:
Lot # VESA17013-A, exp. 10/2019 Lot # VESA17014-A, exp. 10/2019 Lot # VESA18001-A, exp. 12/2019 Lot # VESA18002-A, exp. 12/2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0365-2019
Lot/product code:
Lot # HRSA17033-A, exp. date 10/2020 Lot # HRSA17034-A, exp. date 10/2020 Lot # HRSA17035-A, exp. date 10/2020 Lot # HRSA17036-A, exp. date 10/2020 Lot # HRSA17037-A, exp. date 10/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the 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-1038-2019
Lot/product code:
Lot Numbers: 471170015A, exp. date Sep 2019; 471180004A, 471180005A, exp. date Feb 2019
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0369-2019
Lot/product code:
Lot # HVSB17023-A, exp. date 08/2020 Lot # HVSB17036-A, exp. date 11/2020 Lot # HVSB17037-A, exp. date 11/2020 Lot # HVSB17038-A, exp. date 11/2020 Lot # HVSB17039-A, exp. date 11/2020 Lot # HVSB17040-B, exp. date 11/2020 Lot # HVSB18001-A, exp. date 12/2020 Lot # HVSB18002-A, exp. date 12/2020 Lot # HVSB18003-A, exp. date 12/2020 Lot # HVSB18004-A, exp. date 12/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 31, 2018

Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

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-0362-2019
Lot/product code:
Lot # VFSA17008-A, exp. 10/2019 Lot # VFSA17010-A, exp. 10/2019 Lot # VFSA18002-A, exp. 01/2020 Lot# VFSA18003-A, exp. 01/2020 Lot # VFSA18007-A, exp. 03/2020 Lot # VFSA18008-A, exp. 03/2020 Lot # VKSA17008-A, exp. 05/2019 Lot # VFSA17009-A, exp. 10/2019 Lot # VKSA17014-A, exp. 10/2019 Lot # VKSA17015-A, exp. 10/2019 Lot # VKSA17016-A, exp. 10/2019 Lot # VKSA17017-A, exp. 10/2019 Lot # VKSA18002-A, exp. 01/2020 Lot # VKSA18004-A, exp. 01/2020
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2019

A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x15 20 A Link Z Ti Unitary Plate-Cage 32x21x17 12 A Link Z Ti Unitary Plate-Cage 32x21x17 16 A Link Z Ti Unitary Plate-Cage 32x21x17 20 A Link Z Ti Unitary Plate-Cage 32x21x19 20 A Link Z Ti Unitary Plate-Cage 32x24x15 7 A Link Z Ti Unitary Plate-Cage 32x24x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 12 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 16 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Plate-Cage 36x26x15 20 A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.

Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

ALL 50 STATES
Full report

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

Recall #:
85642
Lot/product code:
Product Product Description Lot Number Number 14-32211507 A Link Z Ti Unitary Plate-Cage 32x21x15 7 1000638 14-32211512 A Link Z Ti Unitary Plate-Cage 32x21x15 12 1000259 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000260 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000325 14-32211516 A Link Z Ti Unitary Plate-Cage 32x21x15 16 1000529 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000261 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000469 14-32211520 A Link Z Ti Unitary Plate-Cage 32x21x15 20 1000556 14-32211712 A Link Z Ti Unitary Plate-Cage 32x21x17 12 1000262 14-32211716 A Link Z Ti Unitary Plate-Cage 32x21x17 16 1000640 14-32211720 A Link Z Ti Unitary Plate-Cage 32x21x17 20 1000641 14-32211920 A Link Z Ti Unitary Plate-Cage 32x21x19 20 1000530 14-32241507 A Link Z Ti Unitary Plate-Cage 32x24x15 7 1000211 14-32241516 A Link Z Ti Unitary Plate-Cage 32x24x15 16 1000536 14-36261512 A Link Z Ti Unitary Plate-Cage 36x26x15 12 1000282 14-36261512 A Link Z Ti Unitary Plate-Cage 36x26x15 12 1000583 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000232 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000383 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000479 14-36261516 A Link Z Ti Unitary Plate-Cage 36x26x15 16 1000652 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000233 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000360 14-36261520 A Link Z Ti Unitary Plate-Cage 36x26x15 20 1000584 15-32241207 A Link Z Ti Unitary Open Interbody 32x24x12 7 1000572 15-32241212 A Link Z Ti Unitary Open Interbody 32x24x12 12 1000573 15-32241607 A Link Z Ti Unitary Open Interbody 32x24x16 7 1000576 15-32241612 A Link Z Ti Unitary Open Interbody 32x24x16 12 1000577
Recalling firm:
Acuity Surgical Devices, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 7, 2019

A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.

Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

ALL 50 STATES
Full report

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

Recall #:
85642
Lot/product code:
Product Product Description Lot Number Number 15-32241207 A Link Z Ti Unitary Open Interbody 32x24x12 7 1000572 15-32241212 A Link Z Ti Unitary Open Interbody 32x24x12 12 1000573 15-32241607 A Link Z Ti Unitary Open Interbody 32x24x16 7 1000576 15-32241612 A Link Z Ti Unitary Open Interbody 32x24x16 12 1000577
Recalling firm:
Acuity Surgical Devices, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is difficult to grasp small objects by hand and increased precise function is required. Applications in which sterile forceps are commonly used include wound care: e.g. gripping, debridement procedures, removal of sutures, arrangement of dressing procedure pack contents, dressing wounds, including cavity wounds and removal of wound tissue.

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
82039
Lot/product code:
Product Code/REF Number: 417389; Lot Codes: 167069, 168288, 171981, 176327, 179936, 182217, 187735, 225174, 231247, 231248, 307362, 307578, 308189, 318432, 318433, 318434, 489868, 489951, 490747, 493969
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
CN11102185 CN11102186 CN11102187 CN11102188 CN11102189 CN11102190 CN11102223 CN11102224 CN11102287 CN11204687 CN11204688 CN11204689 CN11204690 CN11204691 CN11204692 CN11204698 CN11204699 CN11204700 CN11204701 CN11204702 CN11204703 CN11204704 CN11204705 CN11204706 CN11204707 CN11204708 CN11204709 CN11204710 CN11204711 CN11204712 CN11204713 CN11204714 CN11204715 CN11204758 CN11204759 CN11204760 CN11204761 CN11204762 CN11204763 CN11204764 CN11204765 CN11204766 CN11204767 CN11204768 CN11204769 CN11204770 CN11204771 CN11204772 CN11204773 CN11204774 CN11204775 CN11204776 CN11204777 CN11204778 CN11204779 CN11204780 CN11204820 CN11306743 CN11306744 CN11306745 CN11306746 CN11306763 CN11306764 CN11306765 CN11306766 CN11306767 CN11306768 CN11306829 CN11306830 CN11306831 CN11306832 CN11306833 CN11306834 CN11510041 CN11510042 CN11510043 CN11510044 CN11510045 CN11510046 CN11510047 CN11510048 CN11510049 CN11510050 CN11510051 CN11510052 CN11510053 CN11510074 CN11510075 CN11510076 CN11510077 CN11510078 CN11510079 CN11510080 CN11510081 CN11510082 CN11510083 CN11510084 CN11510085 CN11510086 CN11510087 CN11510088 CN11510089 CN11510090 CN11510091 CN11510092 CN11510093 CN11510094 CN11510095 CN11510096 CN11510097 CN11510098 CN11630118 CN11630119 CN11630120 CN11630121 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630127 CN11630128 CN11630129 CN11630130 CN11630131 CN11630137 CN11630139 CN11630140 CN11630141 CN11630142 CN11630149 CN11630150 CN11630151 CN11630152 CN11630153 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630161 CN11630162 CN11630163 CN11630164 CN11630165 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195 CN11731415 CN11731422 CN11731423 CN11731424 CN11731425 CN11731426 CN11731427 CN11731428 CN11731429 CN11731430 CN11731431 CN11731432 CN11731433 CN11731434 CN11731435 CN11731436 CN11731437 CN11731438 CN11731439 CN11731440 CN11731441 CN11731442 CN11731443 CN11731444 CN11731445 CN11731446 CN11731447 CN11731448 CN11731449 CN11731450 CN11731452 CN11731453 CN11731454 CN11731455 CN11731456 CN11731457 CN11731463 CN11731464 CN11731465 CN11731466 CN11731467 CN11731468 CN11731469 CN11832357 CN11832358 CN11832359 CN11832360 CN11832361 CN11832362 CN11832363 CN11832368 CN11832369 CN11832370 CN11832371 CN11832372 CN11832373 CN11832378 CN11832379 CN11832380 CN11832381 CN11832382 CN11832383 CN11832384 CN11832385 CN11832386 CN11832387 CN11832388 CN11832389 CN11832390 CN11832391 CN11832392 CN11832393 CN11832394 CN11832395 CN11832396 CN11832397 CN11832398 CN11832399 CN11832405 CN11832406 CN11832407 CN11832408 CN11832409 CN11832410 CN11832411 CN11832412 CN11832413 CN11832414 CN11832415 CN11832416 CN11832417 CN11832418 CN11832419 CN11832420 CN11832421 CN11832422 CN11832423 CN11832424 CN11832425 CN11832426 CN11832427 CN11832428 CN11832429 CN11832430 CN11832431 CN11832432 CN11832434 CN11832435 CN11832436 CN11832437 CN11832438 CN11832439 CN11832440 CN11832441 CN11832442 CN11832443 CN11832444 CN11832445 CN11832446 CN11832447 CN11832448 CN11832449 CN11832450 CN11832451 CN11832452 CN11832453 CN11832454 CN21102482 CN21102483 CN21102484 CN21102485 CN21102486 CN21102487 CN21204898 CN21204899 CN21204902 CN21204903 CN21204904 CN21204905 CN21204913 CN21204914 CN21204915 CN21204916 CN21204917 CN21204918 CN21204919 CN21204920 CN21204921 CN21204922 CN21204923 CN21204924 CN21204925 CN21204926 CN21204927 CN21204928 CN21204929 CN21204930 CN21204931 CN21204932 CN21204933 CN21204934 CN21204935 CN21204936 CN21204937 CN21204938 CN21204939 CN21204940 CN21204941 CN21204942 CN21204943 CN21204944 CN21204945 CN21204946 CN21204947 CN21205039 CN21205068 CN21205069 CN21205070 CN21205071 CN21205072 CN21205073 CN21205074 CN21205075 CN21205076 CN21205077 CN21205078 CN21205079 CN21205080 CN21205081 CN21205082 CN21205083 CN21205093 CN21205094 CN21306944 CN21306947 CN21306948 CN21306949 CN21306950 CN21306951 CN21408619 CN21408620 CN21510155 CN21510156 CN21510157 CN21510158 CN21510159 CN21510160 CN21510161 CN21510162 CN21510163 CN21510164 CN21510165 CN21510166 CN21510167 CN21510168 CN21510169 CN21510170 CN21510171 CN21510172 CN21510173 CN21510174 CN21510206 CN21510207 CN21510208 CN21510209 CN21510210 CN21510211 CN21510212 CN21510213 CN21510214 CN21510215 CN21510216 CN21510217 CN21510218 CN21510221 CN21510232 CN21510233 CN21510234 CN21510235 CN21510236 CN21510237 CN21510238 CN21510239 CN21510240 CN21510241 CN21510242 CN21510243 CN21510244 CN21510245 CN21510246 CN21510247 CN21510248 CN21510249 CN21510327 CN21510328 CN21510329 CN21510330 CN21510331 CN21510332 CN21510333 CN21510334 CN21510335 CN21510336 CN21510337 CN21510338 CN21510341 CN21510342 CN21510343 CN21510344 CN21510345 CN21510346 CN21510347 CN21510348 CN21510349 CN21510350 CN21510351 CN21510352 CN21510353 CN21510354 CN21510355 CN21510356 CN21510357 CN21510358 CN21510359 CN21630261 CN21630262 CN21630263 CN21630264 CN21630265 CN21630266 CN21630267 CN21630268 CN21630269 CN21630272 CN21630273 CN21630274 CN21630275 CN2163… (truncated, 145628 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
82039
Lot/product code:
Product Code/REF Number: 504159; Lot Codes: 176482, 189027
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
CN80811000 CN80811001 F5N7000106 F5N7000107 F5O7000002 F5O7000024 F5O7000027 F5O7000037 F5O7000078 F5O7000085 F5O7000091 F5O7000093 US10901771 US10901772 US10901773 US10901774 US10901775 US10901776 US10901777 US10901778 US10901779 US10901782 US10901783 US10901784 US10901785 US10901786 US10901787 US10901788 US10901789 US10901790 US10901791 US10901792 US10901793 US10901794 US10901795 US10901796 US10901797 US10901798 US10901799 US10901800 US10901801 US10901802 US10901803 US10901804 US10901805 US10901806 US10901807 US10901808 US10901809 US10901810 US10901811 US10901812 US10901813 US10901814 US10901815 US10901816 US10901817 US10901818 US10901819 US10901821 US10901822 US10901823 US10901824 US10901825 US10901826 US10901829 US10901830 US10901831 US10901832 US10901833 US10901834 US10901835 US10901836 US10901837 US10901838 US10901839 US10901840 US10901841 US10901842 US10901843 US10901844 US10901845 US10901846 US10901847 US10901848 US10901850 US10901851 US10901852 US10901853 US10901854 US10901855 US10901856 US10901857 US10901858 US10901859 US10901860 US10901861 US10901862 US10901863 US10901864 US10901865 US10901866 US10901867 US10901868 US10901869 US10901870 US10901871 US10901872 US10901873 US10901874 US10901887 US10901888 US10901889 US10901890 US10901891 US10901892 US10901893 US10901894 US10901895 US10901896 US10901897 US10901898 US10901899 US10901900 US10901901 US10901902 US10901907 US10901908 US10901909 US10901910 US10901911 US10901912 US10901913 US10901914 US10901915 US10901916 US10901917 US10901918 US10901919 US10901920 US10901921 US10901922 US10901923 US10901924 US10901925 US10901926 US10901927 US10901928 US10901929 US10901930 US10901931 US10901932 US10901933 US10901934 US10901938 US10901939 US10901940 US10901941 US10901942 US10901943 US10901944 US10901945 US10901946 US10901947 US10901948 US10901949 US10901950 US10901951 US10901952 US10901953 US10901954 US10901955 US10901956 US10901957 US10901958 US10901959 US10901960 US10901961 US10901962 US10901963 US10901964 US10901965 US10901966 US10901967 US10901968 US10901969 US10901970 US10901971 US10901972 US10901973 US10901974 US10901975 US10901976 US10901977 US10901978 US10901979 US10901980 US10901981 US10901982 US10901983 US10901984 US10901985 US10901986 US10901987 US10901988 US10901989 US10901990 US10901991 US10901992 US10901993 US10901994 US10901995 US10901996 US10901997 US10901998 US10901999 US10902000 US10902001 US10902002 US10902003 US10902004 US10902005 US10902006 US10902007 US10902008 US10902009 US10902010 US11003987 US11003988 US11003989 US11003990 US11003991 US11003992 US11003993 US11003994 US11003995 US11003996 US11003997 US11003998 US11003999 US11004000 US11004001 US11004002 US11004003 US11004004 US11004005 US11004006 US11004007 US11004008 US11004009 US11004010 US11004011 US11004012 US11004013 US11004014 US11004015 US11004016 US11004017 US11004018 US11004019 US11004020 US11004021 US11004022 US11004024 US11004025 US11004026 US11004027 US11004028 US11004029 US11004030 US11004031 US11004032 US11004033 US11004034 US11004035 US11004036 US11004037 US11004038 US11004039 US11004040 US11004041 US11004042 US11004043 US11004044 US11004045 US11004046 US11004047 US11004048 US11004049 US11004050 US11004051 US11004052 US11004053 US11004054 US11004055 US11004056 US11004057 US11004058 US11004059 US11004060 US11004061 US11004062 US11004063 US11004064 US11004065 US11004066 US11004068 US11004069 US11004070 US11004071 US11004072 US11004073 US11004074 US11004075 US11004076 US11004077 US11004078 US11004079 US11004080 US11004081 US11004082 US11004083 US11004084 US11004085 US11004086 US11004087 US11004088 US11004089 US11004090 US11004091 US11004092 US11004093 US11004094 US11004095 US11004096 US11004097 US11004098 US11004099 US11004100 US11004101 US11004102 US11004103 US11004104 US11004105 US11004106 US11004107 US11004108 US11004109 US11004110 US11004111 US11004112 US11004113 US11004114 US11004115 US11004116 US11004117 US11004118 US11004119 US11004120 US11004121 US11004122 US11004123 US11004124 US11004125 US11004126 US11004127 US11004128 US11004129 US11004130 US11004131 US11004132 US11004133 US11004134 US11004135 US11004136 US11004137 US11004138 US11004139 US11004140 US11004141 US11004142 US11004143 US11004144 US11004145 US11004146 US11004147 US11004148 US11004149 US11004150 US11004151 US11004152 US11004153 US11004154 US11004155 US11004156 US11004157 US11004158 US11004159 US11004161 US11004162 US11004163 US11004164 US11004165 US11004166 US11004167 US11004168 US11004169 US11004170 US11004171 US11004172 US11105738 US11105739 US11105740 US11105741 US11105742 US11105743 US11105744 US11105745 US11105746 US11105747 US11105748 US11105749 US11105750 US11105751 US11105752 US11105753 US11105754 US11105755 US11105756 US11105757 US11105758 US11105759 US11105760 US11105761 US11105762 US11105763 US11105764 US11105765 US11105766 US11105767 US11105768 US11105769 US11105770 US11105771 US11105772 US11105773 US11105774 US11105775 US11105776 US11105777 US11105778 US11105779 US11105780 US11105781 US1110… (truncated, 166197 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
82039
Lot/product code:
Product Codes/REF Numbers: 505599, 505603; Lot Codes: 222348, 222349
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

ALL 50 STATES
Full report

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

Recall #:
82039
Lot/product code:
Product Codes/REF Numbers: 417350, 417354; Lot Codes: 7D04313, 7E03449, 150723, 150957, 155792, 157603, 170833, 183854, 183855, 234561, 487048
Recalling firm:
ConvaTec, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
US91412044 USO1513631
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
US41510645 US41510646 US71630792 USN1206382 USN1206383 USN1409879 USO1631023
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
CN11102314 CN11102315 CN11102316 CN11102317 CN11203436 CN11203443 CN11203444 CN11203453 CN11203454 CN11203455 CN11304748 CN11304749 CN11304762 CN11304772 CN11304773 CN11304802 CN11304803 CN11304805 CN11304806 CN11304809 CN11406020 CN11406033 CN11406034 CN11507236 CN11507237 CN11507238 CN11507259 CN11507260 CN11507261 CN11507262 CN11507263 CN11507264 CN11630099 CN11630100 CN11630101 CN11630102 CN11630103 CN11630104 CN11630105 CN11630106 CN11630107 CN11630108 CN11630109 CN11630110 CN11630111 CN11630112 CN11630113 CN11630114 CN11630122 CN11630123 CN11630124 CN11630125 CN11630126 CN11630128 CN11630129 CN11630130 CN11630131 CN11630132 CN11630133 CN11630134 CN11630135 CN11630136 CN11630138 CN11630139 CN11630140 CN11630141 CN11630142 CN11630143 CN11630144 CN11630145 CN11630146 CN11630147 CN11630148 CN11630149 CN11630150 CN11630151 CN11630154 CN11630155 CN11630156 CN11630157 CN11630158 CN11630159 CN11630160 CN11630164 CN11630165 CN11630166 CN11630173 CN11630174 CN11630175 CN11630176 CN11630177 CN11630178 CN11630179 CN11630180 CN11630181 CN11630182 CN11630183 CN11630184 CN11630185 CN11630186 CN11630187 CN11630188 CN11630189 CN11630190 CN11630191 CN11630192 CN11630193 CN11630194 CN11630195 CN11630196 CN11630197 CN11630198 CN11630199 CN11630200 CN11630201 CN11630202 CN11630203 CN11630204 CN11731556 CN11731557 CN11731558 CN11731559 CN11731560 CN11731561 CN11731562 CN11731563 CN11731564 CN11731565 CN11731566 CN11731567 CN11731568 CN11731575 CN11731576 CN11731577 CN11731578 CN11731579 CN11731580 CN11731581 CN11731582 CN11731583 CN11731584 CN11731585 CN11731586 CN11731593 CN11731594 CN11840066 CN11840067 CN11840068 CN11840069 CN11840071 CN11840072 CN11840073 CN11840080 CN11840081 CN11840082 CN11840083 CN11840084 CN11840085 CN11840086 CN11840087 CN11840088 CN11840089 CN11840090 CN11840091 CN11840092 CN11840093 CN11840094 CN11840095 CN11840096 CN11840097 CN11840098 CN11840099 CN11840100 CN11840101 CN11840103 CN11840104 CN11840105 CN11840106 CN11840107 CN11840108 CN11840109 CN11840110 CN11840111 CN11840112 CN11840113 CN11840114 CN11840115 CN11840116 CN11840117 CN11840118 CN11840119 CN11840120 CN11840121 CN11840122 CN11840123 CN11840124 CN11840125 CN11840126 CN21102408 CN21102409 CN21102420 CN21102431 CN21203548 CN21203549 CN21203558 CN21203563 CN21203564 CN21203565 CN21203566 CN21203567 CN21203568 CN21203677 CN21304888 CN21304889 CN21304890 CN21304901 CN21304902 CN21304903 CN21304904 CN21406160 CN21406161 CN21406162 CN21406163 CN21406164 CN21406165 CN21406166 CN21406167 CN21406168 CN21406169 CN21406170 CN21406171 CN21406172 CN21406173 CN21507275 CN21507297 CN21507298 CN21507299 CN21507300 CN21507301 CN21507302 CN21507303 CN21507304 CN21507313 CN21507314 CN21507316 CN21507317 CN21507318 CN21507319 CN21507320 CN21507321 CN21507368 CN21507369 CN21507370 CN21507371 CN21507372 CN21507373 CN21507374 CN21507375 CN21507376 CN21507377 CN21507378 CN21507379 CN21507380 CN21507381 CN21507382 CN21630218 CN21630219 CN21630220 CN21630221 CN21630222 CN21630223 CN21630224 CN21630225 CN21630226 CN21630227 CN21630228 CN21630229 CN21630230 CN21630231 CN21630232 CN21630233 CN21630234 CN21630235 CN21630236 CN21630237 CN21630238 CN21630239 CN21630240 CN21630241 CN21630242 CN21630243 CN21630244 CN21630245 CN21630246 CN21630247 CN21630248 CN21630249 CN21630250 CN21630251 CN21630252 CN21630253 CN21630254 CN21630255 CN21630256 CN21630257 CN21630258 CN21630259 CN21630260 CN21630261 CN21630262 CN21630263 CN21630264 CN21630265 CN21630266 CN21630267 CN21630268 CN21630286 CN21630287 CN21630290 CN21630291 CN21630292 CN21630293 CN21630294 CN21630295 CN21630296 CN21630297 CN21630298 CN21630299 CN21630300 CN21630301 CN21630302 CN21630303 CN21731603 CN21731604 CN21731605 CN21731612 CN21731613 CN21731614 CN21731615 CN21731616 CN21731617 CN21731618 CN21731620 CN21731621 CN21731622 CN21731623 CN21731624 CN21731625 CN21731626 CN21731653 CN21731654 CN21731655 CN21731656 CN21731657 CN21731658 CN21731659 CN21731660 CN21731661 CN21731662 CN21731663 CN21731664 CN21731665 CN21731666 CN21731667 CN21731668 CN21731669 CN21731670 CN21731672 CN21731673 CN21731674 CN21731675 CN21731676 CN21731677 CN21731678 CN21731679 CN21731680 CN21731681 CN21731682 CN21731683 CN21731684 CN21731685 CN21731686 CN21731687 CN21731688 CN21731689 CN21731690 CN21731691 CN21731692 CN21731693 CN21731694 CN21731695 CN21731696 CN21731697 CN21731698 CN21731699 CN21731700 CN21731701 CN21731702 CN21731703 CN21731704 CN21731705 CN21731706 CN21731707 CN21731708 CN21731709 CN21731710 CN21731711 CN21731715 CN21731716 CN21731717 CN21731718 CN21731719 CN21731720 CN21731721 CN21840127 CN21840128 CN21840129 CN21840130 CN21840131 CN21840174 CN21840175 CN21840176 CN21840177 CN21840178 CN21840179 CN21840180 CN21840181 CN21840182 CN21840183 CN21840184 CN21840185 CN31102445 CN31102448 CN31102449 CN31102450 CN31102451 CN31102456 CN31102457 CN31102458 CN31102459 CN31102460 CN31102461 CN31102462 CN31102477 CN31102488 CN31102489 CN31102520 CN31102521 CN31102522 CN31102547 CN31203690 CN31203691 CN31203697 CN31203698 CN3120… (truncated, 124651 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
US31510433 US31630351 US31630352 US31630353 US51510712 US51510713 US61510947 US61630668 US61630669 US81731977 US81731978 US91511381 US91511445 USO1511461
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
CN11201318 CN11201319 CN11201320 CN11201321 CN11201322 CN11201323 CN11201324 CN11201325 CN11201326 CN11201327 CN11201328 CN11201329 CN11201330 CN11201331 CN11201332 CN11201333 CN11201334 CN11201335 CN11201336 CN11201337 CN11201338 CN11201339 CN11201340 CN11201341 CN11201342 CN11201343 CN11201344 CN11201345 CN11201346 CN11201347 CN11201348 CN11201349 CN11201350 CN11201351 CN11201352 CN11201353 CN11201354 CN11201355 CN11201356 CN11201357 CN11201358 CN11201359 CN11201360 CN11201361 CN11201362 CN11201363 CN11201364 CN11201365 CN11201366 CN11201371 CN11201372 CN11201373 CN11201374 CN11201375 CN11201376 CN11201377 CN11201378 CN11201379 CN11201380 CN11201381 CN11201382 CN11201383 CN11201384 CN11201385 CN11201386 CN11201387 CN11201388 CN11201389 CN11201390 CN11201391 CN11201392 CN11201393 CN11201394 CN11302185 CN11302186 CN11302187 CN11302188 CN11302190 CN11302191 CN11302192 CN11302193 CN11302194 CN11302195 CN11302196 CN11302197 CN11302198 CN11302199 CN11302200 CN11302201 CN11302202 CN11302203 CN11302204 CN11302205 CN11302206 CN11302207 CN11302208 CN11302209 CN11302210 CN11302211 CN11302212 CN11302213 CN11302214 CN11302215 CN11302216 CN11302217 CN11302218 CN11302219 CN11302220 CN11302221 CN11302222 CN11302223 CN11302224 CN11302225 CN11302226 CN11302227 CN11302228 CN11302229 CN11302230 CN11302231 CN11302232 CN11302233 CN11302234 CN11302235 CN11302236 CN11302237 CN11302238 CN11302239 CN11302240 CN11302241 CN11302242 CN11302243 CN11302244 CN11302245 CN11302246 CN11404143 CN11404144 CN11404145 CN11404146 CN11404147 CN11404148 CN11404149 CN11404150 CN11404151 CN11404152 CN11404153 CN11404154 CN11404155 CN11404156 CN11404157 CN11404158 CN11404159 CN11404160 CN11404161 CN11404162 CN11404163 CN11404164 CN11404165 CN11404166 CN11404167 CN11404168 CN11404169 CN11404170 CN11404171 CN11404172 CN11404173 CN11404174 CN11404175 CN11404176 CN11404177 CN11404178 CN11404179 CN11404180 CN11404181 CN11404182 CN11404183 CN11404184 CN11404185 CN11404186 CN11404187 CN11404188 CN11404189 CN11404190 CN11404191 CN11404192 CN11404193 CN11404194 CN11404195 CN11404196 CN11404197 CN11404198 CN11404199 CN11404200 CN11404201 CN11404202 CN11404203 CN11404204 CN11404205 CN11404206 CN11404207 CN11404208 CN11404209 CN11404210 CN11404211 CN11404212 CN11404213 CN11404214 CN11404215 CN11404216 CN11404217 CN11404218 CN11404219 CN11404220 CN11404221 CN11404222 CN11404223 CN11404224 CN11404225 CN11404226 CN11404227 CN11404228 CN11506224 CN11506225 CN11506226 CN11506227 CN11506228 CN11506229 CN11506230 CN11506231 CN11506232 CN11506233 CN11506234 CN11506235 CN11506236 CN11506237 CN11506238 CN11506239 CN11506240 CN11506241 CN11506242 CN11506243 CN11506244 CN11506245 CN11506246 CN11506247 CN11506248 CN11506249 CN11506250 CN11506251 CN11506252 CN11506253 CN11506254 CN11506255 CN11506256 CN11506257 CN11506258 CN11506259 CN11506260 CN11506261 CN11506262 CN11506263 CN11506264 CN11506265 CN11506266 CN11506267 CN11506268 CN11506269 CN11506270 CN11506271 CN11506272 CN11506273 CN11506274 CN11506275 CN11506276 CN11506277 CN11506278 CN11506279 CN11506280 CN11506281 CN11506282 CN11506283 CN11506284 CN11506285 CN11506286 CN11506292 CN11506293 CN11506294 CN11506295 CN11506296 CN11506297 CN11506298 CN11506299 CN11506300 CN11506301 CN11506302 CN11506303 CN11506304 CN11506305 CN11506306 CN11506307 CN11506308 CN11506309 CN11506310 CN11506311 CN11506312 CN11506313 CN11506314 CN11506315 CN11506316 CN11506317 CN11506318 CN11506319 CN11506320 CN11506321 CN11506322 CN11506323 CN11506324 CN11506325 CN11506326 CN11506327 CN11506328 CN11506329 CN11506330 CN11506331 CN11506332 CN11506333 CN11506334 CN11506335 CN11506336 CN11506337 CN11506338 CN11506339 CN11506340 CN11506341 CN11506342 CN11506343 CN11506344 CN11506345 CN11506346 CN11506347 CN11506348 CN11506349 CN11506350 CN11506351 CN11506352 CN11506353 CN11506354 CN11506355 CN11506356 CN11506357 CN11506358 CN11506359 CN11506360 CN11506361 CN11506362 CN11506363 CN11506364 CN11506365 CN11506366 CN11506367 CN11506368 CN11506369 CN11506370 CN11506371 CN11506372 CN11506373 CN11506374 CN11506375 CN11506376 CN11506379 CN11506380 CN11506381 CN11506382 CN11506383 CN11506384 CN11506385 CN11506386 CN11506387 CN11506388 CN11506389 CN11506390 CN11506391 CN11506392 CN11506393 CN11506394 CN11506395 CN11506396 CN11506397 CN11506398 CN11506399 CN11506400 CN11506401 CN11506402 CN11506403 CN11506404 CN11506405 CN11506406 CN11506407 CN11506408 CN11506409 CN11506410 CN11506411 CN11506412 CN11506413 CN11506414 CN11506415 CN11506416 CN11506417 CN11506418 CN11506419 CN11506420 CN11506421 CN11506422 CN11506423 CN11506424 CN11506425 CN11506426 CN11506427 CN11506428 CN11506429 CN11506430 CN11506431 CN11506432 CN11506433 CN11506434 CN11506435 CN11506436 CN11506437 CN11506438 CN11506439 CN11506440 CN11506441 CN11506442 CN11506443 CN11506444 CN11506445 CN11506446 CN11506447 CN11506448 CN11506449 CN11506450 CN11506451 CN11506452 CN11506453 CN11506454 CN11506455 CN11506456 CN11506457 CN11506458 CN11506459 CN11506460 CN11506461 CN11506462 CN11506463 CN11506464 CN1150… (truncated, 154736 characters total — see the official FDA record for the full value)
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
US21512485 US21512486 US21512487 US21512488 US21512489 US21512490 US31722466 US31722467 US31722468 US31722469 US41513026 US61722772 US61722773 US71621391 US71722865 US71722866 US81208557 US81208558 US81309947 US81411777 US81411819 US81411820 US81621422 US91412024 US91412025 US91412026 US91513515 US91513521 US91513522 US91513585 US91621626 USD1513746 USN1621889 USN1723144 USN1723145 USO1310393 USO1310394 USO1310395 USO1310396 USO1513640 USO1621655 USO1831199 USO1831200 USO1831201 USO1831202 USO1831208 USO1831209 USO1831210 USO1831211 USO1831212 USO1831213 USO1831214 USO1831215 USO1831216 USO1831217 USO1831218 USO1831219
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 9, 2019

PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients

Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.

ALL 50 STATES
Full report

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

Recall #:
81957
Lot/product code:
USN1800002 USN1800003 USN1800004
Recalling firm:
Philips North America, LLC
View official FDA record (opens in a new tab)