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Recalls affecting Mississippi

Data last updated: September 10, 2026 at 1:16 PM UTC

16,712 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

ALL 50 STATES
▸Full report

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

Recall #:
88058
Lot/product code:
All Serial Numbers  Material Numbers: AC250S AC550S AH250HS AH250S AH260HS AH260S AH260TS AH450HS AH450S AH550HS AH550S AH650HS AH650S AH750HS AH750S AU151HS AU151S AU251HS AU251S AU451HS AU451S AU551HS AU551S AU651HS AU651S AU751HS AU751S CA151HS CA151S CA251HS CA251S CA451HS CA451S CA551HS CA551S CA651HS CA651S CA751HS CA751S CN157HS CN157S CN257HS CN257S CN457HS CN457S CN557HS CN557S CN657HS CN657S CN757HS CN757S DE452HS DE452S DE552HS DE552S DE752HS DE752S DS150HS DS150S DS250HS DS250S DS450HS DS450S DS550HS DS550S DS650HS DS650S DS750HS DS750S FR355HS FR355S FR555HS FR555S HL454S HL554S IN151HS IN151S IN251HS IN251S IN451HS IN451S IN551HS IN551S IN651HS IN651S IN751HS IN751S JP256HS JP456HS JP456S JP556HS JP556S JP656HS JP756HS JP756S KP250HS KP250S KP450HS KP450S KP550HS KP550S KP750HS KP750S LA151HS LA151S LA251HS LA251S LA451HS LA451S LA551HS LA551S LA651HS LA651S LA751HS LA751S RIN551S RJP556S SH558HS SH558S UODS150S UODS250S UODS450S UODS550S UODS560S UODS650S UODS750S RTODS650HS 151BR LA151SBR 151P 157P 250P 251BR LA251SBR RBRLA251SBR 251P RBRLA251HS RBRLA251S 255P FR255HS FR255S 257P 355P 450P 451BR LA451SBR RBRLA451SBR 451P RIN451S RBRLA451HS RBRLA451S 452P UDE452S 454P 456P RJP456S 457P 550P 551BR LA551SBR RBRLA551SBR 551P RBRLA551HS RBRLA551S 552P UDE552S 554P 555P 556P 557P 651BR LA651SBR RBRLA651S RBRLA651SBR 651P 657P 750P 751BR LA751SBR RBRLA751SBR 751P RBRLA751HS RBRLA751S 752P 756P RJP756S 757P AU151H CA151 CA151H CA451HC CA451W CA551C CA551HC CN157 DS150 DS450C DS450D DS550C DS550HC KP450C KP450HC KP550C KP550HC RDS150S RDS250S RDS450S RDS520S RDS550HS RDS550S RDS650S RDS750HS RDS750S RIN751S UDS150S UDS250S UDS450S UDS520S UDS550S UDS650S UDS750S AHX200H11 AHX200H11C AHX200H11W AHX200S11 AHX200T11 AHX200T11C AHX200T11W AHX400H11 AHX400H11C AHX400H11W AHX400S11 AHX400T11 AHX400T11C AHX400T11W AHX500H11 AHX500H11C AHX500H11W AHX500S11 AHX500T11 AHX500T11C AHX500T11W AHX600H11 AHX600H11C AHX600H11W AHX600S11 AHX600T11 AHX600T11C AHX600T11W AHX700H11 AHX700H11C AHX700H11W AHX700S11 AHX700T11 AHX700T11C AHX700T11W ARX200H15 ARX200S15 ARX401H15 ARX401S15 ARX500H15 ARX500S15 ARX600H15 ARX600S15 ARX700H15 ARX700S15 AUX400H15 AUX400S15 AUX400T15 AUX400T15C AUX500H15 AUX500S15 AUX500T15 AUX500T15C AUX700H15 AUX700S15 AUX700T15 AUX700T15C BLX200H15 BLX200S15 BLX201S15 BLX201S15C BLX400H15 BLX400H15C BLX400S15 BLX400S15C BLX500H15 BLX500H15C BLX500H15MQ BLX500S15 BLX500S15C BLX600H15 BLX600S15 BLX700H15 BLX700S15 BRX200S18 BRX400S18 BRX404S18 BRX500S18 BRX504S18 BRX600S18 BRX700S18 CAX200H12 CAX200S12 CAX200T12 CAX400H12 CAX400H12C CAX400H12W CAX400S12 CAX400T12 CAX400T12C CAX400T12W CAX500H12 CAX500H12C CAX500H12W CAX500S12 CAX500S12C CAX500S12W CAX500T12 CAX500T12C CAX500T12W CAX501H12 CAX501H12C CAX501H12W CAX501T12 CAX501T12C CAX501T12W CAX600H12 CAX600H12C CAX600H12W CAX600S12 CAX600T12 CAX600T12C CAX600T12W CAX700H12 CAX700H12C CAX700H12W CAX700S12 CAX700S12C CAX700S12W CAX700T12 CAX700T12C CAX700T12W CNX200H17 CNX200T17 CNX400H17 CNX400T17 CNX500H17 CNX500T17 CNX600H17 CNX600T17 CNX700H17 CNX700T17 DEX400S13 DEX500S13 DEX700S13 DNX500H11C DNX500T11C DSX200H11 DSX200H11C DSX200H11W DSX200S11 DSX200S11C DSX200S11W DSX200T11 DSX200T11C DSX200T11W DSX400H11 DSX400H11C DSX400H11W DSX400S11 DSX400T11 DSX400T11C DSX400T11W DSX500H11 DSX500H11C DSX500H11CEP DSX500H11EP DSX500H11W DSX500H11WEP DSX500S11 DSX500S11C DSX500S11W DSX500T11 DSX500T11C DSX500T11CEP DSX500T11CMK DSX500T11EP DSX500T11W DSX500T11WEP DSX500T11WMK DSX600H11 DSX600H11C DSX600H11W DSX600S11 DSX600T11 DSX600T11C DSX600T11W DSX700H11 DSX700H11C DSX700H11CEP DSX700H11EP DSX700H11W DSX700H11WEP DSX700S11 DSX700S11C DSX700S11W DSX700T11 DSX700T11C DSX700T11CEP DSX700T11CMK DSX700T11EP DSX700T11W DSX700T11WEP DSX700T11WMK EEX200H15 EEX200S15 EEX400H15 EEX400S15 EEX401H15 EEX401S15 EEX500H15 EEX500S15 EEX600H15 EEX600S15 EEX700H15 EEX700S15 ESX200H15 ESX200S15 ESX201S15 ESX201S15C ESX400H15 ESX400S15 ESX401H15 ESX401H15C ESX401S15 ESX401S15C ESX401S15PR ESX500H15 ESX500H15C ESX500S15 ESX500S15C ESX600H15 ESX600S15 ESX700H15 ESX700S15 EUX200H15 EUX200S15 EUX400H15 EUX400S15 EUX401H15 EUX401S15 EUX500H15 EUX500S15 EUX600H15 EUX600S15 EUX700H15 EUX700S15 FRX400S14 FRX400S14W FRX401S14 FRX500S14 FRX500S14W FRX501H14W FRX501S14 FRX501S14W FRX700S14 FRX700S14W GBX200H15 GBX200S15 GBX400H15 GBX400S15 GBX401H15 GBX401S15 GBX500H15 GBX500S15 GBX600H15 GBX600S15 GBX700H15 GBX700S15 INX200H15 INX200S15 INX200T15 INX400H15 INX400S15 INX400T15 INX500H15 INX500S15 INX500T15 INX600H15 INX600S15 INX600T15 INX700H15 INX700S15 INX700T15 ITX200H15 ITX200S15 ITX400H15 ITX400H15W ITX400S15 ITX500H15 ITX500H15W ITX500S15 ITX600H15 ITX600S15 ITX700H15 ITX700S15 JPX400S16 JPX400S16C JPX500S16 JPX500S16C JPX501S16 JPX700S16 JPX700S16C KRX200H15 KRX200S15 KRX200T15 KRX400H15 KRX400S15 KRX400T15 KRX500H15 KRX500S15 KRX500T15 KRX600H15 KRX600S15 KRX600T15 KRX700H15 KRX700S15 KRX700T15 LAX200H15 LAX200S15 LAX200T15 LAX400H15 LAX400S15 LAX400T15 LAX500H15 LAX500S15… (truncated, 6805 characters total — see the official FDA record for the full value)
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

ALL 50 STATES
▸Full report

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

Recall #:
88449
Lot/product code:
PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (EU).
Recalling firm:
Ion Beam Applications S.A.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

ALL 50 STATES
▸Full report

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

Recall #:
88116
Lot/product code:
Optima CT660 12HW28.8 14HW30.3 15HW25.2 13HW38.14 15HW13.7 Revolution EVO 14HW17.4 15HW13.7 Optima CT680 13HW38.14 15BW21.2
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

ALL 50 STATES
▸Full report

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

Recall #:
88071
Lot/product code:
All Devices manufactured before 26 April 2021, All device serial numbers.  Material Numbers 1040001 1054096 1054097 1054260 1054655 1058180 1119867 1040001B 1054096B 1054096NB 1054097B 1054260B 1054655B 1054655TP 1054655TPV 1058180B AU1054096 AU1054096B BR1054096 BT1054096 BT1054260 CA1054096 CA1054096B CN1054096 IT1054096B KO1054096 KR1054096 LA1054096 LG1054096 R1054096 R1054096B R1054097 R1054097B R1054260 R1054260B R1054655 R1054655B R1054655TP R1054655TPV R1119867 RSL1054260 RSL1054260B RTO1054260 RTO1054260B U1054096 U1054096B U1054097 U1054097B U1054260 U1054260B U1054655 RBR1054096 RTO1119867 1032800 1032802 1032804 1040002 1040005 1032800B 1032802B 1032804B 1032804TP 1032804TPV 1040002B 1040005B 1125564B AU1032800 AU1032800B BR1032800 CA1032800 CA1032800B IT1032800B KO1032800 KR1032800 LA1032800 LG1032800 R1032800 R1032802 R1032804 R1032804B R1032804TP R1032804TPV R1040005 R1040005B RTO1040005B SP1032800B U1032800 U1032802 U1032804 U1040005 U1040005B
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

ALL 50 STATES
▸Full report

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

Recall #:
88071
Lot/product code:
All Devices manufactured before 26 April 2021, All device serial numbers.  Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

ALL 50 STATES
▸Full report

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

Recall #:
88058
Lot/product code:
All Serial Numbers  Material Numbers: DSX9999H11 INX9999H19 RINX9999H19
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

ALL 50 STATES
▸Full report

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

Recall #:
88200
Lot/product code:
Lots 12758314 and 13022357
Recalling firm:
Arthrex, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 14, 2021

A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

ALL 50 STATES
▸Full report

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

Recall #:
88071
Lot/product code:
All Devices manufactured before 26 April 2021, All device serial numbers.  Material Numbers 1076492 1076493 1076495 1076538 1076539 1076565 1076566 1076579 1076580 1076583 1076584 1076586 1078226 1078297 1104171 1111168 1111169 1111170 1111171 1111172 1111173 1111174 1111175 1111176 1111177 1116156 1122129 1140798 1140799 1111170S 1111170-S AR1111169 BR1076493 BR1076566 BR1111169 CN1076493 CN1076566 CN1111169 GB-SPK0011 GB-SPK0012 IT1111169 LA1076493 LA1076566 R1076495 R1111169 R1111177 R1116156 1104170 R1111175 RBR1111169 U1116156 1038916 1038917 1040716 1044114 1044235 1038987 1040717 1068942 1068943 1042900 1042901 1042903 1042904 1042906 1042907 1044288 1044289 1040718 1067255 1029744 1029750 1029756 1029757 1029758 1029759 AU1029756 CA1029756 CA1029759 LA1029756 1030075 1055770 1055813
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 18, 2021

Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

ALL 50 STATES
▸Full report

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

Recall #:
88127
Lot/product code:
Model V60 Plus Ventilator: P/N 1138747 and 1137276;  US System Serial Number/UDI Code: 100363973/ ; 100366525/ ; 100366542/ ; 100371876/ (01)00884838090996(21)100371876; 100373102/ (01)00884838090996(21)100373102; 100374459/ (01)00884838090996(21)100374459; 100376350/ (01)00884838090996(21)100376350; 100377311/ (01)00884838090996(21)100377311; 100377324/ (01)00884838090996(21)100377324; 100380441/ (01)00884838090996(21)100380441; 100382407/ (01)00884838090996(21)100382407; 100382452/ (01)00884838090996(21)100382452; 100382461/ (01)00884838090996(21)100382461; 100384413/ (01)00884838090996(21)100384413; 100384748/ (01)00884838090996(21)100384748; 100385425/ (01)00884838090996(21)100385425; 100385428/ (01)00884838090996(21)100385428; 100385429/ (01)00884838090996(21)100385429; 100385447/ (01)00884838090996(21)100385447; 100385529/ (01)00884838090996(21)100385529; 100386081/ (01)00884838090996(21)100386081; 100386137/ (01)00884838090996(21)100386137; 100386179/ 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(01)00884838090996(21)100412293; 100412450/ (01)00884838090996(21)100412450; 100412596/ (01)00884838090996(21)100412596; 100412940/ (01)00884838090996(21)100412940; 100412943/ (01)00884838090996(21)100412943; 100412976/ (01)00884838090996(21)100412976; 100412980/ (01)00884838090996(21)100412980; 100412981/ (01)00884838090996(21)100412981; 100413021/ (01)00884838090996(21)100413021; 100413027/ (01)00884838090996(21)100413027; 100413028/ (01)00884838090996(21)100413028; 100413030/ (01)00884838090996(21)100413030; 100413033/ (01)00884838090996(21)100413033; 100413524/ (01)00884838090996(21)100413524; 100413571/ (01)00884838090996(21)100413571; 100413663/ (01)00884838090996(21)100413663; 100413670/ (01)00884838090996(21)100413670; 100413672/ (01)00884838090996(21)100413672; 100413837/ (01)00884838090996(21)100413837; 100413905/ (01)00884838090996(21)100413905; 100413990/ (01)00884838090996(21)100413990; 100414030/ (01)00884838090996(21)100414030; 100414034/ (01)00884838090996(21)100414034; 100414256/ (01)00884838090996(21)100414256; 100414346/ (01)00884838090996(21)100414346; 100414349/ (01)00884838090996(21)1… (truncated, 21466 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 18, 2021

Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where the system pressure reaches the maximum limit and sounds the "Cannot Reach Target Flow" alarm , the system will reduce pressure and simultaneously decreasing the flow rate to a level below what was set by the clinicians. If the reason for the increase in pressure is not resolved, the ventilator will continue to provide the lower flow rate, which result in patients experiencing oxygen desaturation which can be characterized as moderate or severe hypoxemia.

ALL 50 STATES
▸Full report

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

Recall #:
88127
Lot/product code:
Model V60 Ventilator: P/N 1053613, 1053614, 1053615, 1053616, 1053617, DU1053617, U1053617, 1076716, 1137292  US System Serial Number/UDI Code: 100351272 (01)00884838020054(21)100351272 100006691  100193211  100220566 (01)00884838020054(21)100220566 100313757 (01)00884838020054(21)100313757 100313412 (01)00884838020054(21)100313412 100080135  100081569  100110187  100121703  100013472  100230650 (01)00884838020054(21)100230650 100374411 (01)00884838020054(21)100374411 100054305  100068863  100188390  100181283  100030036  100030039  100030046  100030040  100043349  100030041  100037246  201029401 (01)00884838020054(21)201029401 100278366 (01)00884838020054(21)100278366 100088340  100131320  201030489 (01)00884838020054(21)201030489 100057026  100074563  201005638  201001514  100027860  201005635  100154662  100056752  100130449  100154846  100078004  100055123  100191452  100077709  100015080  100191788  100129710  100028046  100077079  201017909  100224361 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Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 18, 2021

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.

ALL 50 STATES
▸Full report

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

Recall #:
88426
Lot/product code:
Serial Numbers: 1709VG0832 1803CE0680 1803CE0681 1803CE0682 1803CE0683 1803CE0684 1803CE0685 1803CE0686 1803CE0687 1803CE0688 1803CE0689 1803CE1024 1803CE1025 1803CE1026 1803CE1027 1803CE1028 1803CE1029 1803CE1030 1803CE1031 1803CE1032 1803CE1033 1803CE1084 1803CE1085 1803CE1086 1803CE1087 1804CE0171 1804CE0172 1804CE0173 1804CE0174 1804CE0175 1804CE0176 1804CE0177 1804CE0178 1804CE0179 1804CE0180 1804CE0292 1804CE0293 1804CE0294 1804CE0295 1804CE0296 1804CE0297 1804CE0298 1804CE0299 1804CE0300 1804CE0301 1805CE0298 1805CE0299 1805CE0300 1805CE0301 1805CE0302 1805CE0303 1805CE0304 1805CE0305 1805CE0306 1805CE0307 1805CE0362 1805CE0363 1805CE0364 1805CE0365 1805CE0366 1805CE0367 1805CE0368 1805CE0369 1805CE0370 1805CE0371 1805CE0805 1805CE0806 1805CE0807 1805CE0808 1805CE0809 1805CE0810 1805CE0811 1805CE0812 1805CE0813 1805CE0814 1806CE0013 1806CE0014 1806CE0015 1806CE0016 1806CE0017 1806CE0018 1806CE0019 1806CE0020 1806CE0021 1806CE0022 1806CE0318 1806CE0319 1806CE0320 1806CE0321 1806CE0322 1806CE0323 1806CE0324 1806CE0325 1806CE0326 1806CE0327 1806CE0328 1806CE0329 1806CE0330 1806CE0331 1806CE0332 1806CE0333 1806CE0334 1806CE0335 1806CE0336 1806CE0337 1807CE0343 1807CE0344 1807CE0345 1807CE0346 1807CE0347 1807CE0348 1807CE0349 1807CE0350 1807CE0351 1807CE0425 1807CE0426 1807CE0427 1807CE0428 1807CE0429 1807CE0430 1807CE0431 1807CE0432 1807CE0433 1807CE0434 1807CE0467 1807CE0468 1807CE0469 1807CE0470 1807CE0471 1807CE0472 1807CE0473 1807CE0474 1807CE0475 1807CE0476 1807CE0551 1807CE0552 1807CE0553 1807CE0554 1807CE0555 1807CE0556 1807CE0557 1807CE0558 1807CE0559 1807CE0560 1807CE0601 1807CE0602 1807CE0603 1807CE0604 1807CE0605 1807CE0606 1807CE0607 1807CE0608 1807CE0609 1807CE0610 1807CE0658 1807CE0659 1807CE0660 1807CE0661 1807CE0662 1807CE0663 1807CE0664 1807CE0665 1807CE0666 1807CE0667 1807CE0825 1807CE0826 1807CE0827 1807CE0828 1807CE0829 1807CE0830 1807CE0831 1807CE0832 1807CE0833 1807CE0834 1807CE0915 1807CE0916 1807CE0917 1807CE0918 1807CE0919 1807CE0920 1807CE0921 1807CE0922 1807CE0923 1807CE0924 1808CE0001 1808CE0002 1808CE0003 1808CE0004 1808CE0005 1808CE0006 1808CE0007 1808CE0008 1808CE0009 1808CE0010 1808CE0047 1808CE0048 1808CE0049 1808CE0050 1808CE0051 1808CE0052 1808CE0053 1808CE0054 1808CE0055 1808CE0056 1808CE0089 1808CE0090 1808CE0091 1808CE0092 1808CE0093 1808CE0094 1808CE0095 1808CE0096 1808CE0097 1808CE0098 1808CE0176 1808CE0177 1808CE0178 1808CE0179 1808CE0180 1808CE0181 1808CE0182 1808CE0183 1808CE0184 1808CE0185 1808CE0294 1808CE0295 1808CE0296 1808CE0297 1808CE0298 1808CE0299 1808CE0300 1808CE0301 1808CE0302 1808CE0303 1808CE0324 1808CE0325 1808CE0326 1808CE0327 1808CE0328 1808CE0329 1808CE0330 1808CE0331 1808CE0332 1808CE0333 1808CE0736 1808CE0737 1808CE0738 1808CE0739 1808CE0740 1808CE0741 1808CE0742 1808CE0743 1808CE0744 1808CE0745 1808CE0766 1808CE0767 1808CE0768 1808CE0769 1808CE0770 1808CE0771 1808CE0772 1808CE0773 1808CE0774 1808CE0775 1808CE0797 1808CE0798 1808CE0799 1808CE0800 1808CE0801 1808CE0802 1808CE0803 1808CE0804 1808CE0805 1808CE0806 1808CE0859 1808CE0860 1808CE0861 1808CE0862 1808CE0863 1808CE0864 1808CE0865 1808CE0866 1808CE0867 1808CE0868 1808CE0890 1808CE0891 1808CE0892 1808CE0893 1808CE0894 1808CE0895 1808CE0896 1808CE0897 1808CE0898 1808CE0899 1808CE0972 1808CE0973 1808CE0974 1808CE0975 1808CE0976 1808CE0977 1808CE0978 1808CE0979 1808CE0980 1808CE0981 1809CE0094 1809CE0095 1809CE0096 1809CE0097 1809CE0098 1809CE0099 1809CE0100 1809CE0101 1809CE0102 1809CE0103 1809CE0134 1809CE0135 1809CE0136 1809CE0137 1809CE0138 1809CE0139 1809CE0140 1809CE0141 1809CE0142 1809CE0143 1809CE0461 1809CE0462 1809CE0463 1809CE0464 1809CE0465 1809CE0466 1809CE0467 1809CE0468 1809CE0469 1809CE0470 1809CE0471 1809CE0472 1809CE0504 1809CE0505 1809CE0506 1809CE0507 1809CE0508 1809CE0509 1809CE0510 1809CE0511 1809CE0512 1809CE0513 1809CE0631 1809CE0632 1809CE0633 1809CE0634 1809CE0635 1809CE0636 1809CE0637 1809CE0638 1809CE0639 1809CE0640 1809CE0735 1809CE0736 1809CE0737 1809CE0738 1809CE0739 1809CE0740 1809CE0741 1809CE0742 1809CE0743 1809CE0744 1809CE0810 1809CE0811 1809CE0812 1809CE0813 1809CE0814 1809CE0815 1809CE0816 1809CE0817 1809CE0818 1809CE0819 1809CE0974 1809CE0975 1809CE0976 1809CE0977 1809CE0978 1809CE0979 1809CE0980 1809CE0981 1809CE0982 1809CE0983 1809CE1039 1809CE1040 1809CE1041 1809CE1042 1809CE1043 1809CE1044 1809CE1045 1809CE1046 1809CE1047 1809CE1048 1809CE1121 1809CE1122 1809CE1123 1809CE1124 1809CE1125 1809CE1126 1809CE1127 1809CE1128 1809CE1129 1809CE1130 1809CE1211 1809CE1212 1809CE1213 1809CE1214 1809CE1215 1809CE1216 1809CE1217 1809CE1218 1809CE1219 1809CE1220 1811CE0620 1811CE0621 1811CE0622 1811CE0623 1811CE0624 1811CE0625 1811CE0626 1811CE0627 1811CE0628 1811CE0629 1811CE1006 1811CE1007 1811CE1008 1811CE1009 1811CE1010 1811CE1011 1811CE1012 1811CE1013 1811CE1014 1811CE1015 1811CE1113 1811CE1114 1811CE1115 1811CE1116 1811CE1117 1811CE1118 1811CE1119 1811CE1120 1811CE1121 1811CE1122 1811CE1123 1811CE1124 1812CE0499 1812CE0500 1812CE0501 1812CE0502 1812CE0503 1… (truncated, 12115 characters total — see the official FDA record for the full value)
Recalling firm:
WOM World of Medicine AG
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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▸Full report

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

Recall #:
88234
Lot/product code:
a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
▸Full report

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

Recall #:
88234
Lot/product code:
a) REF 3738522, Lot 00A2160813 b) REF 3738822, Lot 00A1160822
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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

Recall #:
88234
Lot/product code:
a) REF 3814773, Lot 11T00118 b) REF 3835773, Lot 11T00119 c) REF 3825773, Lot 11T00120 d) REF 3837773, Lot 11T00121 e) REF 3846773, Lot 11T00122 f) REF 3831473, Lot 11T00142 g) REF 3842473, Lot 11T00143 h) REF 3821473, Lot 11T00146 i) REF 3832473, Lot 11T00147 j) REF 3833473, Lot 11T00148 k) REF 3821573, Lot 11T00177 l) REF 3831573, Lot 11T00178 m) REF 3833573, Lot 11T00179 n) REF 3824773, Lot 11T00230 o) REF 3804773, Lot 11T00231 p) REF 3845773, Lot 11T00232 q) REF 3811473, Lot 11T05089 r) REF 3836773, Lot 11T05136 s) REF 3843473, Lot 11T05166 t) REF 3800473, Lot 11T10007 v) REF 3842573, Lot 12T00180 w) REF 3832573, Lot 11T10015 x) REF 3847773, Lot 11T10016 y) REF 3800573, Lot T1010018
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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

Recall #:
88234
Lot/product code:
Lot 00A1160806
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter:

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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

Recall #:
88234
Lot/product code:
REF 3738522, Lot 00A2160813 REF 3738822, Lot 00A1160822
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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

Recall #:
88234
Lot/product code:
a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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

Recall #:
88234
Lot/product code:
a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std Backrest, Electric; Serial Numbers: 10001-SC2-20 to 10135-SC2-20; 10001-SC2-21 to 10240-SC2-21. Model Number: CHAIR-0-SC3-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Manual; Serial Numbers: 10116-SC3-20 to 10145-SC3-20; 10236-SC3-20 to 10295-SC3-20; 10001-SC3-21 to 10090-SC3-21; 10271-SC3-21 to 10360-SC3-21; 10001-SC3-20 to 10115-SC3-20; 10146-SC3-20 to 10235-SC3-20. Model Number: CHAIR-0-SC4-050; Advance Chair, 125/150mm (5in/6in) Castors, Standard Backrest, Electric; Serial Numbers: 10001-SC4-20 to 10030-SC4-20.

The firm has identified a potential for the backrest to become detached from the chair.

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

Recall #:
88441
Lot/product code:
Serial Numbers (Domestically distributed) 10001-SC3-20 to 10115-SC3-20 10146-SC3-20 to 10235-SC3-20
Recalling firm:
Accora Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA Self Safe, I.V. Catheter REF 3738222

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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

Recall #:
88234
Lot/product code:
REF 3738222, Lot 00A1160625
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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

Recall #:
88234
Lot/product code:
a) REF 3832072, Lot 11T80190 b) REF 3810072, Lot 11T80303 c) REF 3842072, Lot 12T80342 d) REF 3852072, Lot 12T80348
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

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

Recall #:
96078
Lot/product code:
Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K
Recalling firm:
Murata Vios, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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

Recall #:
88234
Lot/product code:
REF 3708122, Lot 00A1160627
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 21, 2021

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

ALL 50 STATES
▸Full report

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

Recall #:
88234
Lot/product code:
a) REF 3832572: Lot 11T80189 b) REF 3842572, Lot 11T80198 c) REF 3821572, Lot 11T80149 d) REF 3833572, Lot 11T80292 e) REF 3831572, Lot 12T80230 f) REF 3810572, Lot 12T80302 g) REF 3852572, Lot 12T80349
Recalling firm:
Delta Med SpA
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled June 22, 2021

Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0691-2021
Lot/product code:
Batch Number # 079932-4611-05-J, exp. date May 2022
Recalling firm:
Ardil Comercial S.R.L.
View official FDA record (opens in a new tab)