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Recalls affecting District of Columbia

Data last updated: September 9, 2026 at 1:18 PM UTC

16,214 recalls found

Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

▸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

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
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High riskLow riskAll
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84430
Lot/product code:
All Serial Numbers ( excluding devices with black retainer rings)
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84430
Lot/product code:
All Serial Numbers ( excluding devices with black retainer rings) ***NOT DISTRIBUTED WITHIN THE US***
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US

There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
84430
Lot/product code:
All Serial Numbers ( excluding devices with black retainer rings) ***NOT DISTRIBUTED WITHIN THE US***
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 21, 2019

DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.

ALL 50 STATES
▸Full report

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

Recall #:
84364
Lot/product code:
1) REF KB9000-01 Lot Numbers: 9798560, 49798543, 49976101, 49798578, 49976119, 50166762, 50166842, 50353058, 50353066, 50353074, 50353082, 50353091, 50353103, 50471126, 50575494, 50555223  2) REF 11-450A-00 Lot Numbers: 9798480, 50226649, 50226665, 49832318, 49976047, 50034962, 49976063, 49976071, 50167028, 50167052, 50166949, 50343909, 50353023, 50353031, 50353040, 50429112, 50465800, 50465797, 50555258, 50653675    3) REF 1150UTPP Lot Numbers: 49799386, 49843130, 49910865, 49976645, 49976637, 50166447, 50343870, 50352952, 50352961, 50352979, 50352987, 50352995, 50385594
Recalling firm:
DeRoyal Industries Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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▸Full report

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

Recall #:
D-0615-2020
Lot/product code:
HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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-0616-2020
Lot/product code:
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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-0612-2020
Lot/product code:
AR171764A 11/2019 AR171875A 11/2019 AR171876A 11/2019 AR171981A 11/2019 AR180020C 1/2020 AR180206A 1/2020 AR180207A 1/2020 AR180208A 1/2020 AR180438A 2/2020 AR180439A 2/2020 AR180481A 3/2020 AR180482A 3/2020 AR180483A 3/2020 AR181690A 10/2020 AR181691A 10/2020 AR181806A 11/2020 AR190058A 12/2020 AR190059A 12/2020 AR190183A 1/2021 AR190184A 1/2021 AR171984A 12/2019 AR180020B 1/2020 AR180675A 4/2020 AR180868B 5/2020 AR181807A 11/2020 AR190366B 2/2021 AR171986A 12/2019 AR171987A 12/2019 AR180255A 1/2020 AR180441A 2/2020 AR180442A 2/2020 AR180559A 3/2020 AR180560A 3/2020 AR180594A 3/2020 AR180595A 3/2020 AR180829A 4/2020 AR180831A 5/2020 AR180832A 5/2020 AR180868A 5/2020 AR181807C 11/2020 AR190085A 12/2020 AR190086A 12/2020 AR190087A 12/2020 AR190124A 1/2021 AR190542B 3/2021 AR190609A 3/2021 AR190610A 3/2021 AR171875B 11/2019 AR180483B 3/2020 AR181807B 11/2020 AR190008B 12/2020 AR171763A 11/2019 AR171764B 11/2019 AR171874A 11/2019 AR171875C 11/2019 AR171877B 11/2019 AR171878B 11/2019 AR171982A 11/2019 AR171983A 12/2019 AR171985A 12/2019 AR180016A 12/2019 AR180017A 12/2019 AR180018A 12/2019 AR180019A 12/2019 AR180020A 1/2020 AR180208B 1/2020 AR180256A 1/2020 AR180291A 1/2020 AR180292A 1/2020 AR180293A 1/2020 AR180294A 2/2020 AR180295A 2/2020 AR180364A 2/2020 AR180365A 2/2020 AR180366A 2/2020 AR180367A 2/2020 AR180368A 2/2020 AR180440B 2/2020 AR180484A 3/2020 AR180485A 3/2020 AR180556A 3/2020 AR180557A 3/2020 AR180558A 3/2020 AR180596A 3/2020 AR180597A 3/2020 AR180598A 3/2020 AR180599A 3/2020 AR180675B 4/2020 AR180676A 4/2020 AR180677A 4/2020 AR180678A 4/2020 AR180679A 4/2020 AR180801A 4/2020 AR180802A 4/2020 AR180803A 4/2020 AR180869A 5/2020 AR180870A 5/2020 AR180871A 5/2020 AR180872A 5/2020 AR180994A 5/2020 AR180995A 5/2020 AR180996A 5/2020 AR180997A 6/2020 AR180998A 6/2020 AR181158A 7/2020 AR181159A 7/2020 AR181160A 7/2020 AR181161A 7/2020 AR181692A 10/2020 AR181693A 10/2020 AR181694A 10/2020 AR181709A 10/2020 AR181710A 11/2020 AR181711A 11/2020 AR181808A 11/2020 AR181809A 11/2020 AR190004A 12/2020 AR190005A 12/2020 AR190006A 12/2020 AR190007A 12/2020 AR190008A 12/2020 AR190088A 12/2020 AR190089A 12/2020 AR190090A 12/2020 AR190121A 12/2020 AR190122A 12/2020 AR190123A 12/2020 AR190125B 1/2021 AR190181A 1/2021 AR190182A 1/2021 AR190364A 2/2021 AR190365A 2/2021 AR190366A 2/2021 AR190509A 3/2021 AR190510A 3/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 22, 2019

LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .

The abutment provided with the Implant System may be not meeting quality requirements, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.

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

Recall #:
85369
Lot/product code:
The UDI number for the affected lots are as follows:  Product Name Part #  LOCATOR Overdenture Implant, 2.4mmD x 12mmL,2.5mm Cuff 07451 Lot # L17MB; UDI Number: 00840481101496  LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 4mm Cuff 07456 Lot # Ll5PB; L166F; UDI Number: 00840481101526  LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 4mm Cuff 07465 Lot # L15H7; L15H9; UDI Number: 00840481101571  LOCATOR Overdenture Implant, 2.9mmD x 14mmL, 4mm Cuff 07467 Lot # USHA UDI Number: 00840481101595  LOCATOR Overdenture Implant, 3.4mmD x 12mmL, 4mm Cuff 07476 Lot # L17VE; UDI Number: 00840481126116
Recalling firm:
Zest Anchors LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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-0613-2020
Lot/product code:
AR172033B 11/2019 AR180024A 12/2019 AR180025A 12/2019 AR180118A 12/2019 AR180119A 12/2019 AR180519A 3/2020 AR180615A 3/2020 AR181795A 11/2020 AR181921B 12/2020 AR190705A 4/2021 AR172029A 11/2019 AR172030A 11/2019 AR180021A 12/2019 AR180022A 12/2019 AR180023A 12/2019 AR180123A 12/2019 AR180144A 1/2020 AR180145A 1/2020 AR180146A 1/2020 AR180147A 1/2020 AR180402A 2/2020 AR180465A 2/2020 AR180466A 2/2020 AR180467A 2/2020 AR180468A 2/2020 AR180613A 3/2020 AR181156A 7/2020 AR181157A 7/2020 AR190418B 2/2021 AR171800A 11/2019 AR171801A 11/2019 AR171802A 11/2019 AR171803A 11/2019 AR171804A 11/2019 AR171931A 11/2019 AR171932A 11/2019 AR171933A 11/2019 AR171934A 11/2019 AR171935A 11/2019 AR171936A 11/2019 AR171937A 11/2019 AR172026A 11/2019 AR172027A 11/2019 AR172028A 11/2019 AR172031A 11/2019 AR172032A 11/2019 AR172033A 11/2019 AR172034A 11/2019 AR172035A 11/2019 AR180030A 12/2019 AR180031A 12/2019 AR180032A 12/2019 AR180033A 12/2019 AR180034A 12/2019 AR180113A 12/2019 AR180114A 12/2019 AR180115A 12/2019 AR180117A 12/2019 AR180120A 12/2019 AR180121A 12/2019 AR180122A 12/2019 AR180148A 1/2020 AR180198A 1/2020 AR180199A 1/2020 AR180200A 1/2020 AR180201A 1/2020 AR180202A 1/2020 AR180257A 1/2020 AR180258A 1/2020 AR180335A 2/2020 AR180336A 2/2020 AR180337A 2/2020 AR180338A 2/2020 AR180339A 2/2020 AR180374A 2/2020 AR180375A 2/2020 AR180376B 2/2020 AR180403A 2/2020 AR180404A 2/2020 AR180405A 2/2020 AR180406A 2/2020 AR180424A 2/2020 AR180486A 3/2020 AR180487A 3/2020 AR180488A 3/2020 AR180515A 3/2020 AR180516A 3/2020 AR180517A 3/2020 AR180518A 3/2020 AR180638A 3/2020 AR180640A 4/2020 AR180641A 4/2020 AR181920A 12/2020 AR181921A 12/2020 AR190414B 2/2021 AR190415A 2/2021 AR190416A 2/2021 AR190417A 2/2021 AR190418A 2/2021 AR190543A 3/2021 AR190544A 3/2021 AR190545A 3/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 22, 2019

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

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-0614-2020
Lot/product code:
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Recalling firm:
Amneal Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2019

Lunar iDXA bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

ALL 50 STATES
▸Full report

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

Recall #:
85466
Lot/product code:
all affected systems
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2019

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

ALL 50 STATES
▸Full report

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

Recall #:
85466
Lot/product code:
all affected systems
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2019

Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

ALL 50 STATES
▸Full report

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

Recall #:
85466
Lot/product code:
all affected systems
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2019

Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

ALL 50 STATES
▸Full report

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

Recall #:
85466
Lot/product code:
all affected systems
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2019

ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.

Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

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

Recall #:
84511
Lot/product code:
PRODUCT CODE UDI 7N8300 85412091839 7N8301 85412475387 7N8301K 85412499635 7N8310 85412476728 7N8330K 85412613499 7N8332K 85412599625 7N8334K 85412613482 7N8370K 85412613505 7N8371 85412091822 7N8375K 85412613475 7N8376K 85412599601 7N8377 85412091808 7N8378 85412091792 7N8390 85412475417 7N8391 85412475400 7N8399 85412091785 7N8399K 85412478227   All Lots
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 12, 2019

Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.

Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.

ALL 50 STATES
▸Full report

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

Recall #:
84511
Lot/product code:
Product Codes: 2C8519, UDI 00085412048994; 2C8537, UDI 00085412048970; and 2C8541, UDI 00085412071107 All Lots
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30

CGMP Deviations: Presence of NDMA impurity detected in 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-0641-2020
Lot/product code:
7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01

CGMP Deviations: Presence of NDMA impurity detected in product.

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▸Full report

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

Recall #:
D-0640-2020
Lot/product code:
7701033A 7701826A 7702344A 7702345A 7702489A 7702706A 7702707A 7702708A 7702858A 7702859A 7702860A 7702928A 7702929A 7703196A 7703634A 7704492A 7704493A 7705159A 19190289 19190342 19190372
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01

CGMP Deviations: Presence of NDMA impurity detected in product.

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▸Full report

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

Recall #:
D-0642-2020
Lot/product code:
7701030A 7701031A 7701062A 7701063A 7701110A 7701111A 7701112A 7701185A 7701186A 7701187A 7701188A 7701189A 7701269A 7701270A 7701278A 7701279A 7701386A 7701400A 7701401A 7701406A 7701421A 7701434A 7701435A 7701436A 7701452A 7701453A 7701521A 7701522B 7701553A 7701554A 7701555A 7701556A 7701582A 7701817A 7701828A 7701829A 7702001A 7702002A 7702003A 7702012A 7702026A 7702027A 7702064A 7702140A 7702253A 7702254A 7702285A 7702286A 7702287A 7702288A 7702294A 7702413A 7702462A 7702491A 7702492A 7702504A 7702505A 7702515A 7702698A 7702699A 7702700A 7702714A 7702719A 7702720A 7702747A 7702748A 7702749A 7702750A 7702751A 7702872A 7702873A 7702874A 7702917A 7702918A 7702919A 7702921A 7702922A 7702923A 7702945A 7703205A 7703410A 7703411A 7703412A 7703413A 7703414A 7703415A 7703451A 7703452A 7703453A 7703578A 7703579A 7703580A 7703581A 7703591A 7703592A 7703593A 7704372A 7704373A 7704374A 7704426A 7704427A 7704432A 7704463A 7704464A 7704465A 7704466A 7704508A 7704509A 7704510A 7704511A 7704512A 7704513A 7704563A 7704564A 7704746A 7704747A 7704748A 7704813A 7704841A 7704989A 7704990A 7705106A 7705320A 7705321A 7705322A 7705323A 7705324A 7705325A 7705326A 7705694A 7705703A 7705704A 7705702A 19190456 19190472 19190490 7701809A 7704862A 7704863A 7704864A 7704865A 7704866A 7704933A 7704934A
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20

CGMP Deviations: Presence of NDMA impurity detected in 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-0643-2020
Lot/product code:
7701069A 7701070A 7701084A 7701085A 7701087A 7701094A 7701095A 7701140A 7701141A 7701142A 7701157A 7701162A 7701182A 7701217A 7701218A 7701219A 7701236A 7701237A 7701220A 7701456A 7701470A 7701520A 7701671A 7701696A 7701697A 7701698A 7701797A 7701928A 7701929A 7701942A 7701943A 7702065A 7702066A 7702067A 7702095A 7702096A 7702097A 7702098A 7702188A 7702189A 7702190A 7702196A 7702197A 7702198A 7702199A 7702348A 7702338A 7702347A 7702349A 7702350A 7702391A 7702392A 7702546A 7702547A 7702548A 7702616A 7702617A 7702618A 7702619A 7702620A 7702763A 7702764A 7702851A 7702852A 7702853A 7702854A 7702855A 7702868A 7702869A 7702870A 7702871A 7702920A 7703054A 7703055A 7703056A 7703057A 7703058A 7703206A 7703208A 7703454A 7703455A 7703456A 7703486A 7703487A 7703488A 7703489A 7703490A 7703945A 7703946A 7703947A 7704111A 7704112A 7704113A 7704234A 7704235A 7704236A 7704237A 7704285A 7704286A 7704287A 7704288A 7704370A 7704371A 7704428A 7704429A 7704430A 7704431A 7704814A 7704838A 7704839A 7704840A 7704935A 7704936A 7704992A 7704996A 7704997A 7704998A 7704999A 7705037A 7705298A 7705299A 7705300A 7705301A 7705302A 7705303A 7705546A 7705584A 7705544A 7705545A 7705572A 7705585A 19190456 19190472 19190490 19191934 19191942 19191959 19192504
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodUndeclaredRecalled December 17, 2019

GREY GHOST BAKERY scratch-made cookies LEMON SUGAR NET WT 1.4 OZ (40 G), UPC 8 53152 00308 1 , 4 OZ (113 G) UPC 8 53152 00332 6 & 8 OZ (225 G) UPC 8 53152 00307 4 GREY GHOST BAKERY 1750 SIGNAL POINT RD, STE 2A CHARLESTON, SC 29412

The product contains not listed on the label sulfites.

ALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSNCNHNJNMNYOHOKORPASCTNTXUTVAWAWIWY
▸Full report

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

Recall #:
F-0559-2020
Lot/product code:
1612019, 1622019, 1632019, 1752019, 1772019, 1782019, 1802019, 1822019, 1892019, 1912019, 1962019, 1972019, 1982019, 2042019, 2052019, 2062019, 2082019, 2112019, 2132019, 2142019, 2192019, 2212019, 2252019, 2272019, 2282019, 2312019, 2332019, 2412019, 2542019, 2552019, 2572019, 2632019, 2682019, 2692019, 2712019, 2742019, 2752019, 2762019, 2772019, 2782019, 2822019, 2882019, 2912019, 2922019, 2952019, 2962019, 2972019, 3042019, 3062019, 3082019, 3102019, 3122019, 3172019, 3192019, 3212019, 3252019, 3282019, 3302019, 3362019, 3372019, 3382019, 3452019.
Recalling firm:
TFI Holding dba Grey Ghost Bakery
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60

CGMP Deviations: Presence of NDMA impurity detected in 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-0639-2020
Lot/product code:
7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05

CGMP Deviations: Presence of NDMA impurity detected in 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-0644-2020
Lot/product code:
7701034A 7701057A 7701058A 7701059A 7701060A 7701061A 7701071A 7701072A 7701073A 7701074A 7701105A 7701106A 7701107A 7701108A 7701109A 7701113A 7701114A 7701115A 7701116A 7701121A 7701122A 7701123A 7701124A 7701125A 7701126A 7701151A 7701152A 7701165A 7701154A 7701155A 7701163A 7701176A 7701190A 7701221A 7701222A 7701223A 7701224A 7701225A 7701235A 7701253A 7701254A 7701255A 7701256A 7701257A 7701258A 7701259A 7701266A 7701267A 7701268A 7701273A 7701275A 7701276A 7701277A 7701294A 7701295A 7701296A 7701297A 7701300A 7701301A 7701302A 7701303A 7701304A 7701306A 7701307A 7701308A 7701309A 7701310A 7701311A 7701312A 7701313A 7701314A 7701315A 7701316A 7701328A 7701329A 7701330A 7701331A 7701332A 7701333A 7701344A 7701153A 7701175A 7701234A 7701274A 7701305A 7701345A 7701352A 7701353A 7701354A 7701355A 7701356A 7701382A 7701383A 7701384A 7701385A 7701402A 7701403A 7701404A 7701405A 7701419A 7701420A 7701422A 7701423A 7701424A 7701425A 7701426A 7701427A 7701430A 7701432A 7701433A 7701448A 7701449A 7701450A 7701451A 7701454A 7701455A 7701471B 7701557A 7701558A 7701559A 7701583A 7701584A 7701585A 7701586A 7701587A 7701588A 7701614A 7701615A 7701616A 7701621A 7701637A 7701638A 7701639A 7701652A 7701653A 7701654A 7701655A 7701656A 7701657A 7701658A 7701664A 7701665A 7701666A 7701667A 7701668A 7701669A 7701670A 7701680A 7701613A 7701699A 7701700A 7701701A 7701714A 7701715A 7701716A 7701717A 7701718A 7701719A 7701720A 7701721A 7701781A 7701782A 7701783A 7701784A 7701796A 7701926A 7701927A 7701937A 7701938A 7701939A 7701940A 7701941A 7702004A 7702005A 7702006A 7702007A 7702008A 7702009A 7702010A 7702011A 7702013A 7702014A 7702068A 7702222A 7702223A 7702224A 7702230A 7702231A 7702232A 7702233A 7702242B 7702243A 7702244A 7702245A 7702246A 7702247A 7702248A 7702249A 7702250A 7702251A 7702252A 7702291A 7702292A 7702293A 7702302A 7702303A 7702304A 7702305A 7702306A 7702307A 7702308A 7702309A 7702331A 7702332A 7702333A 7702334A 7702339A 7702340A 7702346A 7702353A 7702354A 7702355A 7702356A 7702376A 7702377A 7702378A 7702379A 7702390A 7702310A 7702411A 7702412A 7702490A 7702493A 7702494A 7702498A 7702499A 7702500A 7702501A 7702502A 7702503A 7702516A 7702517A 7702518A 7702519A 7702549A 7702550A 7702551A 7702552A 7702601A 7702602A 7702603A 7702604A 7702605A 7702606A 7702607A 7702608A 7702621A 7702622A 7702623A 7702655A 7702656A 7702657A 7702658A 7702741A 7702742A 7702743A 7702765A 7702766A 7702777A 7702778A 7702779A 7702780A 7702781A 7702782A 7702783A 7702784A 7702794A 7702795A 7702796A 7702797A 7702811A 7702812A 7702813A 7702814A 7702815A 7702816A 7702817A 7702818A 7702819A 7702820A 7702821A 7702822A 7702848A 7702849A 7702850A 7702856A 7702857A 7702861A 7702896A 7702897A 7702898A 7702899A 7702910A 7702911A 7702912A 7702913A 7702914A 7702915A 7702916A 7702924A 7702925A 7702926A 7702927A 7703060A 7703061A 7703062A 7703063A 7703064A 7703065A 7703066A 7703067A 7703068A 7703144A 7703145A 7703146A 7703147A 7703174A 7703175A 7703176A 7703177A 7703178A 7703179A 7703180A 7703181A 7703182A 7703183A 7703191A 7703192A 7703193A 7703194A 7703195A 7703236A 7703237A 7703238A 7703239A 7703240A 7703248A 7703249A 7703250A 7703251A 7703252A 7703253A 7703254A 7703255A 7703283A 7703284A 7703290A 7703291A 7703292A 7703293A 7703294A 7703295A 7703296A 7703318A 7703330A 7703331A 7703332A 7703333A 7703334A 7703347A 7703348A 7703349A 7703350A 7703351A 7703394A 7703395A 7703409A 7703491A 7703492A 7703493A 7703494A 7703495A 7703496A 7703497A 7703498A 7703499A 7703500A 7703501A 7703502A 7703503A 7703504A 7703635A 7703636A 7703637A 7703638A 7703775A 7703776A 7703777A 7703778A 7703779A 7703780A 7703781A 7703782A 7703783A 7703925A 7703926A 7703934A 7703935A 7703936A 7703937A 7703938A 7703939A 7703970A 7703971A 7703972A 7704003A 7704004A 7704098A 7704099A 7704100A 7704101A 7704102A 7704103A 7704104A 7704181A 7704182A 7704183A 7704184A 7704185A 7704186A 7704187A 7704188A 7704189A 7704190A 7704191A 7704192A 7704193A 7704297A 7704298A 7704299A 7704300A 7704301A 7704302A 7704327A 7704328A 7704329A 7704330A 7704331A 7704332A 7704333A 7704334A 7704408A 7704409A 7704410A 7704411A 7704412A 7704413A 7704419A 7704420A 7704421A 7704422A 7704423A 7704424A 7704425A 7704496A 7704497A 7704502A 7704503A 7704504A 7704505A 7704506A 7704507A 7704559A 7704560A 7704561A 7704562A 7704574A 7704575A 7704606A 7704607A 7704608A 7704649A 7704650A 7704651A 7704652A 7704653A 7704654A 7704655A 7704656A 7704657A 7704658A 7704659A 7704673A 7704674A 7704675A 7704676A 7704677A 7704678A 7704679A 7704735A … (truncated, 6158 characters total — see the official FDA record for the full value)
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2019

Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

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▸Full report

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

Recall #:
84653
Lot/product code:
All units with pump firmware version 0.26 manufactured from 2012 until the present time.  Serial Numbers 10HW4A31 10AZ4A69X 10AZ4A07X 10BZ4A16X 10BZ4A61X 10BZ4A41X 10AZ4A48X 10AZ4A50X 10AZ4A23X 10AZ4A36X 10AZ4A42X 10BZ4A37X 10BZ4A64X 10BZ4A12X 10CZ4B09X 10CZ4A95X 10CZ4B22X 10BZ4A18X 10CZ4A79X 10CZ4A86X 10CZ4A96X 10CZ4A88X 10CZ4A80X 10CZ4A85X 10CZ4A81X 10CZ4A82X 10CZ4A78X 10CZ4A91X 10CZ4A94X 10CZ4A90X 10CZ4A77X 10CZ4B28X 10CZ4B05X 10CZ4B15X 10CZ4B21X 10CZ4A87X 10CZ4B32X 10AZ4A41X 10CZ4B23X 10CZ4A93X 10CZ4B01X 10CZ4B17X 10CZ4B04X 10CZ4B30X 10BZ4A55X 10CZ4B08X 10CZ4A76X 10CZ4B33X 10CZ4B20X 10DZ4A01X 10DZ4A58X 10DZ4A19X 10CZ4B36X 10CZ4A84X 10DZ4A18X 10CZ4B24X 10DZ4A76X 10BZ4A30X 10CZ4B26X 10BZ4A09X 10DZ4A51X 10DZ4A93X 10DZ4A32X 10CZ4B03X 10DZ4A89X 10BZ4A11X 10DZ4A30X 10CZ4B25X 10DZ4A65X 10DZ4A05X 10DZ4A98X 10DZ4A08X 10DZ4A42X 10DZ4A77X 10CZ4A92X 10DZ4A35X 10DZ4A80X 10DZ4A92X 10DZ4A88X 10DZ4A07X 10BZ4A39X 10DZ4A73X 10DZ4A53X 10DZ4A28X 10DZ4A84X 10DZ4A45X 10CZ4B14X 10DZ4A40X 10DZ4A72X 10DZ4A64X 10DZ4A79X 10DZ4A60X 10DZ4A82X 10DZ4A37X 10DZ4B39X 10DZ4A54X 10DZ4A67X 10CZ4B29X 10BZ4A59X 10DZ4A20X 10DZ4A38X 10DZ4B04X 10DZ4A36X 10DZ4A91X 10DZ4B37X 10DZ4B06X 10DZ4A34X 10DZ4A25X 10DZ4B24X 10DZ4B49X 10DZ4B38X 10CZ4A89X 10DZ4B05X 10DZ4A15X 10DZ4A43X 10DZ4B54X 10BZ4A25X 10DZ4A66X 10DZ4B53X 10DZ4A29X 10DZ4A23X 10DZ4B08X 10DZ4A21X 10DZ4B40X 10DZ4A83X 10DZ4A17X 10DZ4A62X 10DZ4B19X 10DZ4B46X 10EZ4A36X 10DZ4B16X 10DZ4A87X 10DZ4B25X 10DZ4B43X 10DZ4B10X 10DZ4B61X 10DZ4B50X 10DZ4B07X 10DZ4B48X 10DZ4B26X 10DZ4B29X 10DZ4A27X 10CZ4B27X 10EZ4A02X 10DZ4B22X 10DZ4B15X 10EZ4A46X 10EZ4A27X 10EZ4A01X 10DZ4A47X 10DZ4A81X 10DZ4A33X 10EZ4A30X 10EZ4A26X 10EZ4A51X 10DZ4B03X 10EZ4A37X 10EZ4A13X 10EZ4A39X 10EZ4A35X 10DZ4B45X 10EZ4A28X 10DZ4A10X 10FZ4A34X 10CZ4B35X 10EZ4A09X 10EZ4A43X 10EZ4A05X 10EZ4A17X 10EZ4A16X 10DZ4B21X 10DZ4A94X 10EZ4A19X 10EZ4A45X 10DZ4A44X 10DZ4A68X 10EZ4A25X 10FZ4A29X 10EZ4A32X 10DZ4A48X 10FZ4A24X 10EZ4A18X 10DZ4B55X 10DZ4A06X 10FZ4A02X 10EZ4A57X 10EZ4A24X 10EZ4A58X 10EZ4A06X 10FZ4A38X 10FZ4A03X 10EZ4A29X 10EZ4A08X 10EZ4A55X 10FZ4A36X 10EZ4A20X 10EZ4A31X 10DZ4B18X 10GZ4A40X 10FZ4A18X 10FZ4A39X 10DZ4B42X 10FZ4A31X 10EZ4A47X 10GZ4A44X 10GZ4A58X 10DZ4B51X 10GZ4A27X 10DZ4B30X 10FZ4A37X 10GZ4A01X 10GZ4A43X 10GZ4A38X 10GZ4A35X 10EZ4A48X 10GZ4A03X 10GZ4A08X 10GZ4A37X 10DZ4B41X 10GZ4A02X 10DZ4B31X 10DZ4A55X 10GZ4A76X 10GZ4A66X 10DZ4B20X 10FZ4A15X 10FZ4A01X 10GZ4A34X 10EZ4A10X 10FZ4A22X 10GZ4A73X 10EZ4A53X 10FZ4A21X 10GZ4A94X 10GZ4A06X 10GZ4A61X 10GZ4A78X 10EZ4A60X 10FZ4A13X 10GZ4A96X 10GZ4A04X 10FZ4A28X 10GZ4A11X 10EZ4A34X 10GZ4A59X 10EZ4A11X 10GZ4A05X 10FZ4A04X 10GZ4A18X 10EZ4A49X 10GZ4A54X 10GZ4A92X 10GZ4A90X 10GZ4A57X 10EZ4A40X 10FZ4A40X 10GZ4A63X 10DZ4A49X 10GZ4A41X 10GZ4A29X 10GZ4A83X 10GZ4B54X 10GZ4A70X 10GZ4A19X 10EZ4A23X 10FZ4A06X 10GZ4A95X 10FZ4A20X 10GZ4A30X 10GZ4A89X 10GZ4A72X 10GZ4A71X 10GZ4A12X 10GZ4B34X 10GZ4B18X 10GZ4A09X 10GZ4B22X 10GZ4A99X 10GZ4A93X 10GZ4A64X 10GZ4A77X 10FZ4A05X 10DZ4A59X 10GZ4A75X 10GZ4A98X 10GZ4B26X 10GZ4A33X 10GZ4B08X 10FZ4A32X 10GZ4B59X 10GZ4B38X 10GZ4B07X 10GZ4B44X 10GZ4B41X 10GZ4A69X 10GZ4A87X 10HZ4A02X 10GZ4B55X 10GZ4B28X 10HZ4A26X 10GZ4A91X 10HZ4A41X 10GZ4B52X 10HZ4A46X 10FZ4A35X 10GZ4B16X 10FZ4A09X 10HZ4A70X 10DZ4A12X 10GZ4B37X 10GZ4A42X 10DZ4B35X 10GZ4A20X 10HZ4A82X 10HZ4A49X 10GZ4A97X 10EZ4A59X 10HZ4A16X 10GZ4A21X 10GZ4A53X 10HZ4A07X 10HZ4A33X 10HZ4A81X 10GZ4B06X 10HZ4A19X 10HZ4A22X 10HZ4A83X 10HZ4A20X 10HZ4A21X 10HZ4A12X 10HZ4A04X 10DZ4B12X 10GZ4A07X 10HZ4A15X 10GZ4B01X 10HZ4A80X 10GZ4A46X 10HZ4A35X 10HZ4A39X 10GZ4B51X 10GZ4B12X 10HZ4A09X 10HZ4A57X 10GZ4B32X 10GZ4B57X 10HZ4A71X 10GZ4B10X 10HZ4A25X 10FZ4A07X 10GZ4B11X 10HZ4A64X 10IZ4B09X 10GZ4A81X 10GZ4B21X 10GZ4B53X 10IZ4A84X 10HZ4A11X 10JZ4A67X 10HZ4A05X 10HZ4A37X 10IZ4A64X 10GZ4B36X 10IZ4A38X 10GZ4B04X 10GZ4B35X 10HZ4A61X 10HZ4A28X 10HZ4A44X 10HZ4A23X 10IZ4A78X 10GZ4B61X 10GZ4A39X 10IZ4A91X 10HZ4A40X 10IZ4B05X 10IZ4A60X 10IZ4B14X 10IZ4A61X 10GZ4B25X 10GZ4B47X 10IZ4A92X 10IZ4B08X 10IZ4B07X 10HZ4A55X 10GZ4B45X 10GZ4B42X 10HZ4A69X 10IZ4A50X 10IZ4A85X 10GZ4A15X 10IZ4B17X 10HZ4A42X 10CZ4B06X 10HZ4A53X 10IZ4A79X 10HZ4A24X 10IZ4A69X 10IZ4A42X 10IZ4A96X 10IZ4A72X 10HZ4A17X 10IZ4B21X 10IZ4A73X 10IZ4A74X 10IZ4A31X 10JZ4A18X 10IZ4A77X 10IZ4A49X 10IZ4A57X 10IZ4A35X 10IZ4B16X 10IZ4B15X 10IZ4A46X 10GZ4A10X 10GZ4B03X 10IZ4A71X 10IZ4A43X 10JZ4A05X 10IZ4B06X 10JZ4A60X 10HZ4A45X 10JZ4A35X 10IZ4A40X 10IZ4A34X 10IZ4A93X 10HZ4A85X 10JZ4A11X 10IZ4B04X 10JZ4A54X 10JZ4A56X 10IZ4A67X 10GZ4A36X 10IZ4B01X 10HZ4A08X 10JZ4A12X 10JZ4A27X 10HZ4A56X 10JZ4A46X 10JZ4A78X 10JZ4A23X 10HZ4A79X 10JZ4A02X 10JZ4A89X 10JZ4A19X 10JZ4A82X 10JZ4A44X 10IZ4A76X 10IZ4A53X 10JZ4A90X 10JZ4A81X 10IZ4B12X 10GZ4B15X 10JZ4A80X 10JZ4A06X 10JZ4A53X 10JZ4A87X 10GZ4B60X 10JZ4A88X 10JZ4A17X 10HZ4A31X 10JZ4A72X 10JZ4A01X 10JZ4A16X 10IZ4A75X 10JZ4A07X 10HZ4A03X 10HZ4A54X 10JZ4A39X 10HZ4A13X 10JZ4A29X 10JZ4A65X 10JZ4A63X 10JZ4A69X 10JZ4A32X 10EZ4A22X 10JZ4A37X 10IZ4A66X 10JZ4A62X 10JZ4A34X 10JZ4A43X 10JZ4A42X 10IZ4A83X 10IZ4A59X 10JZ4B16X 10HZ4A34X 10JZ4A08X 10JZ4B17X 10JZ4B25X 10JZ4B10X 10JZ4B… (truncated, 62563 characters total — see the official FDA record for the full value)
Recalling firm:
Flowonix Medical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 24, 2019

Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

ALL 50 STATES
▸Full report

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

Recall #:
84653
Lot/product code:
All units with pump firmware version 0.26 manufactured from 2012 until the present time.  Serial Numbers 10JW4A32 10HW4A29 10JW4A44 10JW4A35 10HW4A45 10JW4A05 10JW4A08 10JW4A46 10JW4A36 10JW4A30 10JW4A39 10JW4A06 10JW4A21 10JW4A01 10JW4A27 10KW4A47 10JW4A29 10JW4A41 10KW4A122 10JW4A02 10KW4A05 10JW4A25 10KW4A38 10KW4A61 10KW4A11 10KW4A16 10KW4A27 10KW4A08 10KW4A117 10KW4A68 10KW4A99 10KW4A91 10KW4A20 10KW4A53 10KW4A106 10KW4A02 10JW4A20 10KW4A35 10KW4A18 10KW4A101 10AX4A21 10JW4A43 10KW4A73 10KW4A123 10KW4A67 10AX4B27 10KW4A31 10KW4A24 10AX4A37 10KW4A83 10AX4A36 10AX4A22 10AX4A10 10KW4A42 10KW4A119 10AX4B24 10KW4A89 10KW4A71 10KW4A116 10AX4A12 10DX4A79 10DX4A10 10AX4B06 10AX4B09 10DX4A95 10AX4A81 10AX4A98 10KW4A103 10AX4A96 10AX4A95 10AX4B82 10AX4A76 10KW4A48 10HY4C42 10KW4A09 10AX4A88 10DX4A32 10AX4A87 10AX4B92 10GX4B05 10GX4A30 10KW4A104 10AX4A14 10DX4A98 10GX4B21 10AX4A85 10KW4A85 10KW4A06 10AX4A73 10GX4A21 10GX4A09 10DX4A85 10GX4A82 10JW4A31 10GX4A87 10JW4A16 10GX4A85 10KW4A12 10GX4B16 10KW4A43 10GX4A34 10GX4A83 10AX4B78 10GX4B03 10GX4A38 10GX4B08 10KW4A29 10GX4B07 10KW4A30 10GX4A32 10AX4B90 10GX4A70 10AX4B81 10AX4B53 10GX4A92 10KY4A20 10KW4A52 10KW4A39 10GX4A19 10GX4A96 10DX4A21 10KX4A02 10DX4B07 10KX4A12 10KX4A15 10KW4A75 10GX4A99 10KX4A43 10GX4A45 10KX4A40 10KX4A41 10DX4A09 10DX4A74 10DX4A48 10KX4A42 10GX4A97 10GX4A10 10AX4B80 10KX4A59 10JW4A04 10KW4A44 10GX4A73 10KX4A14 10KX4A13 10GX4B15 10KX4A70 10KX4A57 10KX4A74 10KW4A25 10GX4A03 10GX4A63 10GX4A71 10KW4A108 10KX4A85 10KW4A105 10GX4A40 10GX4A14 10DX4A33 10BY4A40 10BY4A51 10BY4A39 10KX4A62 10BY4A25 10BY4A59 10BY4A36 10EY4A53 10KX4A10 10KX4A39 10EY4A27 10KX4A26 10EY4A26 10BY4A60 10EY4A38 10KX4A80 10BY4A57 10EY4A17 10EY4A83 10EY4A03 10BY4A48 10EY4A25 10EY4A29 10EY4A88 10EY4A99 10EY4A59 10EY4A05 10EY4A82 10EY4A19 10EY4A67 10EY4A89 10BY4A52 10KX4A17 10EY4A36 10EY4A58 10EY4A73 10EY4A43 10GX4A12 10KX4A78 10EY4A15 10BY4A34 10GY4A63 10EY4A37 10EY4A98 10KX4A25 10BY4A30 10GY4A16 10EY4A48 10KX4A76 10GY4A11 10GY4A19 10GY4A60 10GY4A55 10GY4A50 10GY4A49 10GY4A54 10BY4A31 10EY4A72 10KX4A11 10GY4A66 10GY4A40 10GY4A18 10EY4A94 10GY4A32 10EY4A13 10EY4A46 10GY4A72 10GY4A20 10GY4A06 10KX4A27 10KX4A08 10GY4A45 10KX4A30 10GY4A25 10KX4A32 10BY4A42 10GY4A15 10HY4B20 10GY4A35 10GY4A12 10GY4A58 10HY4B44 10GY4A23 10HY4B29 10GY4A21 10GY4A31 10GY4A53 10HY4B18 10KX4A29 10GY4A52 10HY4B16 10HY4B42 10HY4A97 10GY4A74 10HY4B48 10GY4A34 10HY4B41 10HY4B03 10EY4A76 10GY4A26 10HY4B23 10HY4B40 10HY4B25 10HY4B37 10HY4B55 10HY4B02 10HY4A85 10HY4B22 10HY4B54 10HY4B07 10HY4B80 10HY4B26 10HY4A78 10HY4C29 10HY4C11 10GY4A52¿ 10GX4B14 10KY4A41 10KX4A71 10GX4B02 10AX4B85 10HY4C03 10HY4B86 10HY4C16 10HY4C46 10HY4C34 10HY4B17 10HY4B65 10HY4B30 10HY4B62 10HY4B56 10HY4C35 10HY4B33 10HY4A81 10HY4C13 10HY4B10 10HY4C07 10HY4C27 10HY4C12 10HY4B96 10HY4B76 10HY4B24 10HY4C08 10HY4C39 10HY4C06 10HY4B83 10HY4C30 10HY4C36 10IY4A46 10HY4C40 10HY4B70 10IY4A29 10HY4C01 10HY4A98 10HY4B08 10IY4A17 10HY4C47 10HY4C32 10HY4C26 10IY4A38 10IY4A25 10HY4A80 10IY4A37 10IY4A43 10HY4C41 10IY4A51 10IY4A19 10IY4A33 10HY4B91 10HY4B51 10JY4A10 10KY4A60 10KY4A93 10KY4A15 10JY4A15 10KY4A21 10IY4A27 10IY4A13 10JY4A18 10JY4A07 10KY4A71 10KY4A39 10KY4A06 10HY4B97 10KY4A72 10KY4A86 10IY4A54 10KY4A87 10KY4A31 10AZ4A51 10KY4A25 10IY4A28 10KY4A50 10AZ4A35 10AZ4A24 10KY4A91 10AZ4A57 10IY4A31 10KY4A78 10KY4A84 10KY4A03 10KY4A82 10KY4A62 10KY4A44 10KY4A13 10HY4A79 10KY4A69 10AZ4A15 10JY4A28 10KY4A51 10JY4A16 10KY4A36 10AZ4A14 10AZ4A65 10KY4A94 10KY4A64 10KY4A47 10KY4A67 10JY4A03 10HY4A91 10AZ4A54 10HY4C23 10AZ4A08 10KY4A40 10AZ4A31 10BZ4A26 10KY4A79 10IY4A04 10EY4A60 10HY4B90 10KY4A90 10EY4A40 10KY4A30 10IY4A02 10AZ4A22
Recalling firm:
Flowonix Medical Inc
View official FDA record (opens in a new tab)