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Recalls affecting Mississippi

Data last updated: September 11, 2026 at 1:08 PM UTC

16,761 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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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)
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)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled December 20, 2021

Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.

Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient's blood vessel and damage the blood vessel.

ALL 50 STATES
Full report

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

Recall #:
89218
Lot/product code:
SID: 30039059, Alphenix System Serial Number: BGC20Y2010, & Flat Panel Detector Serial Number: C1B20Y2215 SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2218; SID: 30030612, Alphenix System Serial Number: B8D20Z2001, & Flat Panel Detector Serial Number: C1B20Z2219; SID: 30046247, Alphenix System Serial Number: B1B20Z2001, & Flat Panel Detector Serial Number: C1B20Z2221; SID: 30064041, Alphenix System Serial Number: BGD2172011, & Flat Panel Detector Serial Number: C1B2172234; SID: 30065145, Alphenix System Serial Number: B1E2172002, & Flat Panel Detector Serial Number: C1B2172235; SID: 30058149, Alphenix System Serial Number: B1E2152001, & Flat Panel Detector Serial Number: C1B2152230; SID: 30002089, Alphenix System Serial Number: BHC20Z2003, & Flat Panel Detector Serial Number: C1B20Z2217.
Recalling firm:
Canon Medical System, USA, INC.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 21, 2021

Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF3216C120EE; ENBF3216C145EE; ENBF3216C170EE; ENBF3616C145EE; ENBF3616C170EE; ENCF2323C45EE; ENCF2525C45EE; ENCF2828C45EE; ENCF3232C45EE; ENCF3636C45EE; ENTF2323C70EE; ENTF2525C70EE; ENTF2828C70EE; Medtronic Endurant II Stent Graft System Model/REF ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C145EJ; ETBF2313C166EE; ETBF2313C166EJ; ETBF2316C124E; ETBF2316C124EE; ETBF2316C124EJ; ETBF2316C145E; ETBF2316C145EE; ETBF2316C145EJ; ETBF2316C166E; ETBF2316C166EE; ETBF2316C166EJ; ETBF2513C124E; ETBF2513C124EE; ETBF2513C124EJ; ETBF2513C145EE; ETBF2513C145EJ; ETBF2513C166E; ETBF2513C166EE; ETBF2513C166EJ; ETBF2516C124EE; ETBF2516C145E; ETBF2516C145EE; ETBF2516C145EJ; ETBF2516C166E; ETBF2516C166EE; ETBF2516C166EJ; ETBF2813C124EE; ETBF2813C124EJ; ETBF2813C145E; ETBF2813C145EE; ETBF2813C145EJ; ETBF2813C166E; ETBF2813C166EE; ETBF2813C166EJ; ETBF2816C124EE; ETBF2816C124EJ; ETBF2816C145E; ETBF2816C145EE; ETBF2816C145EJ; ETBF2816C166E; ETBF2816C166EE; ETBF2816C166EJ; ETBF2820C124EE; ETBF2820C145EE; ETBF2820C145EJ; ETBF2820C166E; ETBF2820C166EE; ETBF2820C166EJ; ETBF3216C124E; ETBF3216C124EE; ETBF3216C124EJ; ETBF3216C145E; ETBF3216C145EE; ETBF3216C145EJ; ETBF3216C166EE; ETBF3216C166EJ; ETBF3220C124EE; ETBF3220C145EE; ETBF3220C166E; ETBF3220C166EE; ETBF3220C166EJ; ETBF3616C145E; ETBF3616C145EE; ETBF3616C145EJ; ETBF3616C166E; ETBF3616C166EE; ETBF3616C166EJ; ETBF3620C145EE; ETBF3620C166EE; ETBF3620C166EJ; ETCF2323C49E; ETCF2323C49EE; ETCF2525C49E; ETCF2525C49EE; ETCF2525C49EJ; ETCF2828C49E; ETCF2828C49EE; ETCF2828C49EJ; ETCF3232C49E; ETCF3232C49EE; ETCF3232C49EJ; ETCF3636C49E; ETCF3636C49EE; ETCF3636C49EJ; ETTF2323C70E; ETTF2323C70EE; ETTF2323C70EJ; ETTF2525C70E; ETTF2525C70EE; ETTF2525C70EJ; ETTF2828C70E; ETTF2828C70EE; ETTF2828C70EJ; ETTF3232C70E; ETTF3232C70EE; ETTF3232C70EJ; ETTF3636C70E; ETTF3636C70EE; ETTF3636C70EJ; ETUF2314C102E; ETUF2314C102EE; ETUF2314C102EJ; ETUF2514C102E; ETUF2514C102EE; ETUF2514C102EJ; ETUF2814C102E; ETUF2814C102EE; ETUF2814C102EJ; ETUF3214C102E; ETUF3214C102EE; ETUF3614C102E; ETUF3614C102EE; Medtronic Endurant IIs Stent Graft System Model/REF: ESBF2314C103E; ESBF2314C103EE; ESBF2314C103EJ; ESBF2514C103E; ESBF2514C103EE; ESBF2514C103EJ; ESBF2814C103E; ESBF2814C103EE; ESBF2814C103EJ; ESBF3214C103E; ESBF3214C103EE; ESBF3214C103EJ; ESBF3614C103E; ESBF3614C103EE; ESBF3614C103EJ; Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

ALL 50 STATES
Full report

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

Recall #:
89387
Lot/product code:
Model Number/GTIN: ENBF2313C120EE/00763000005528 Serial Numbers: V30540648 V30540649 V30540650 ENBF2313C145EE/00763000005535 Serial Numbers: V30528369 V30528370 V30528371 V30528374 V30528375 V30528376 V30528611 V30528612 V30528613 V30528614 V30528615 V30528616 V30528617 V30528618 V30528619 V30544486 V30544487 V30544488 V30544489 V30544491 V30544492 V30544493 V30544494 V30544953 V30544954 V30544955 V30544956 V30544957 V30544958 V30544959 V30544960 V30544961 V30544962 V30579806 V30579807 V30579808 V30579809 V30579810 V30579811 V30579812 V30579813 V30579814 V30579815 V30579816 V30579817 V30579818 V30579819 V30579820 V30579821 V30579822 V30579823 V30579824 V30579825 V30581739 V30581740 V30581741 V30581742 V30581743 V30581744 V30581745 V30581746 V30581747 V30581748 V30581749 V30581750 V30581751 V30581752 V30581753 V30581754 V30581755 V30581756 V30581757 V30581758 V30583356 V30583357 V30583358 V30583359 V30583360 V30603508 V30603509 V30603510 V30603511 V30603512 V30603513 V30603514 V30603515 V30603516 V30603517 V30603518 V30603519 V30603520 V30603521 V30603522 V30603523 V30603524 V30603525 V30603526 V30606497 V30606498 V30606499 V30606500 V30606501 V30606502 V30606503 V30606504 V30606505 V30606506 V30606507 V30606508 V30606509 V30606510 V30606511 V30606512 V30606513 V30606514 V30606515 V30606516 ENBF2313C170EE/00763000005542 Serial Numbers: V30509849 V30509850 V30509851 V30509852 V30543246 V30543247 V30543248 V30543249 V30543250 V30543301 V30543302 V30543303 V30543304 V30543305 V30543306 V30543307 V30543308 V30543309 V30544963 V30544964 V30544965 V30544966 V30544967 V30544968 V30544969 V30544970 V30544971 V30544972 V30544973 V30544974 V30544975 V30544976 V30544977 V30544978 V30544979 V30544980 V30544981 V30544982 V30583361 V30583362 V30583363 V30583364 V30583365 V30583366 V30583367 V30583368 V30583369 V30583370 V30597232 V30597233 V30597234 V30597235 V30597236 V30597237 V30597238 V30597239 V30597240 V30597241 V30597242 V30597243 V30597244 V30597245 V30597246 V30597247 V30597248 V30597249 V30597250 V30597251 V30603528 V30603529 V30603530 V30603531 V30603532 V30603533 V30603534 V30603535 V30603536 V30670374 V30670375 V30670376 V30670377 V30670378 V30670379 V30670380 V30670381 V30670382 V30670383 V30670719 V30670720 V30670721 V30670722 V30670723 V30670724 V30670725 V30670726 ENBF2316C120EE/00763000005559 Serial Numbers: V30529438 V30529439 V30529440 V30529441 V30529442 V30583371 V30583372 V30583373 V30583374 V30583375 ENBF2316C145EE/00763000005566 Serial Numbers: V30509854 V30509855 V30509856 V30509857 V30509858 V30544496 V30544497 V30544498 V30544499 V30544500 V30544501 V30544502 V30544503 V30544504 V30544505 V30544506 V30544507 V30544508 V30544509 V30544510 V30544511 V30544512 V30544513 V30544514 V30544515 V30583376 V30583377 V30583378 V30583379 V30583380 V30583381 V30583382 V30583383 V30583384 V30583385 V30597252 V30597253 V30597254 V30597255 V30597256 V30597257 V30597258 V30597259 V30597260 V30597261 V30597262 V30597263 V30597264 V30597265 V30597266 V30597267 V30597268 V30597269 V30597270 V30597271 V30606517 V30606518 V30606519 V30606520 V30606521 V30606522 V30606523 V30606524 V30606525 V30606526 V30606527 V30606528 V30606529 V30606530 V30606531 V30606532 V30606533 V30606534 V30606535 V30606536 ENBF2316C170EE/00763000005573 Serial Numbers: V30528640 V30528641 V30528642 V30528643 V30528644 V30528645 V30528646 V30528647 V30528648 V30528649 V30529608 V30529609 V30529610 V30529611 V30529612 V30544983 V30544984 V30544985 V30544986 V30544987 V30577699 V30577700 V30577701 V30577702 V30577703 V30577704 V30577705 V30577706 V30577707 V30577708 V30577709 V30577710 V30577711 V30577712 V30577713 V30583386 V30583387 V30583388 V30583389 ENBF2513C120EE/00763000005580 Serial Numbers: V30529613 V30529614 V30529615 V30529616 V30529617 V30583391 V30583392 V30583393 V30583394 V30583395 ENBF2513C145EE/00763000005597 Serial Numbers: V30544516 V30544517 V30544518 V30544519 V30544520 V30544521 V30544522 V30544523 V30544524 V30544525 V30544526 V30544527 V30544528 V30544529 V30544530 V30544531 V30544532 V30544533 V30544534 V30583396 V30583397 V30583398 V30583399 V30583400 V30583401 V30583402 V30583403 V30583404 V30583405 V30583406 V30583407 V30583408 V30583409 V30583410 V30597272 V30597273 V30597274 V30597275 V30597276 V30597277 V30597278 V30597279 V30597280 V30597281 V30597282 V30597283 V30597284 V30597285 V30597286 V30597287 V30597288 V30597289 V30597290 V30597291 V30606537 V30606538 V30606539 V30606540 V30606541 V30606542 V30606543 V30606544 V30606545 ENBF2513C170EE/00763000005603 Serial Numbers: V30541359 V30541360 V30541361 V30541362 V30541363 V30541364 V30541365 V30541366 V30541367 V30541368 V30541369 V30541370 V30541371 V30541372 V30541373 V30541374 V30541375 V30541376 V30541377 V30541378 V30544988 V30544989 V30544990 V30544991 V30544992 V30544993 V30544994 V30544995 V30544996 V30544997 V30544998 V30544999 V30545000 V30545001 V30545002 V30545003 V30545004 V30545005 V30545006 V30545007 V30581789 V30581790 V30581791 V30581792… (truncated, 154209 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 21, 2021

Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

ALL 50 STATES
Full report

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

Recall #:
89456
Lot/product code:
UDI: 07613327013306; Lot Number: 87458602
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 21, 2021

32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

ALL 50 STATES
Full report

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

Recall #:
89456
Lot/product code:
UDI: 07613327012842; Lot Number: 87327407
Recalling firm:
Howmedica Osteonics Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 21, 2021

Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083

Not guaranteed to be germ-free

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-0463-2022
Lot/product code:
All lots within expiry
Recalling firm:
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

ALL 50 STATES
Full report

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

Recall #:
89315
Lot/product code:
all lots
Recalling firm:
Empowered Diagnostics LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 44-20-260-035 Material Number: M00573040

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27465198 27515974 27595732 27625064 27720618 27737252 27765472 27833280 27883444 28002224 28296772 27491776 27595731 27618170 27718421 27758432 27764571 27830207 27858381 28002225 28289452 GTIN: 8714729776659
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

CovClear COVID-19 Rapid Antigen Test, ATG 900-031

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

ALL 50 STATES
Full report

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

Recall #:
89315
Lot/product code:
All lots
Recalling firm:
Empowered Diagnostics LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001

Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.

ALL 50 STATES
Full report

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

Recall #:
89428
Lot/product code:
Lot/Serial No.: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201 21869701, 21983904, 21995301 GTIN: 10886982297372
Recalling firm:
Synthes (USA) Products LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.

Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

ALL 50 STATES
Full report

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

Recall #:
89276
Lot/product code:
Lot Numbers 210414 - 210524
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.

Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

ALL 50 STATES
Full report

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

Recall #:
89276
Lot/product code:
UDI-DI: 00606959051942 (USA); 00606959055483 (Korea) Product Identifier (Serial Numbers): H312385987BBD H31238613E4CA H31241259862E H31241349C52A H312413624849 H31246293D7F5 H29069399D107 H29669926A6D8 H296700951ED2 H296701855DD6 H29674238FF13 H296742474AEC H31220934079E H312209523678 H31220968B34A H280964980B5B H2967018997BA H296723150600 H2967242692F6 H296742253D2E H29674250278B H312207401CA9 H312208968320 H312209071F6D H31220910720A H3122091706B5 H31220928D42A H29670062E9A5 H29670177FD0C H2967017805FB H29672401D5F9 H29672403F6EB H29674270143B H297843621AFA H312413504133 H312209241E46 H312209466984 H2967239902AC H31220819B517 H312208463358 H31220879E1C7 H3122089792A9 H3122092149EB H3122086600E8 H3122093262A8 H31220939DC7B H31220950156A H312209603F02 H31220996D9FC H3122081028D6 H3122083329FD H31220840566E H312208540992 H3122086065DE H31220844104A H312209006BD2 H31220908E79A H3122093041BA H311986468D0A H31198653C37F H31198703E71B H311987378B57 H31199129B193 H311991651C9F H312002723AE6 H3120033750F7 H3120041817B5 H31200649CD3C H3120080642B0 H312008165B68 H312010168111 H3120105192CE H312010580F0F H31201122B781 H31201136E87D H31201153EB00 H31201160F3F3 H31206064B82A H31238478BB71 H31238600CF89 H312386149075 H31238626990F H312413562405 H312413642D7F H312413653CF6 H312413671FE4 H312413707283 H31245188BA57 H31246258C086 H3124630068AA H29670055B772 H29670089CD66 H29670120F70B H29670195440E H296723243DE1 H29672330621D H2967240593DD H29672456DFFE H296742224991 H29784208BBAC H312209272CDD H312209400CB2 H31192401F7C3 H311924097B8B H311924178B2D H3119242493DE H31192433FEB9 H31192470AB42 H3119247399D9 H31192474ED66 H31216909A045 H31216910245C H3121691573F1 H31217046BF77 H312170485609 H31217092492B H31217104A1D9 H312171178A9A H31217131DC1C H31217132EE87 H312171348BB1 H312171359A38 H31217137B92A H312171395054 H31217140809D H31217142A38F H31217146E5AB H312171491D5C H312171509945 H31217152BA57 H31217154DF61 H31217156FC73 H31217158150D H312171590484 H31217161A2A4 H3121716381B6 H31217165E480 H31217167C792 H312171683F65 H312171692EEC H31217171BB7C H3121717289E7 H31217173986E H31217174ECD1 H31217175FD58 H3121717826BD H312171793734 H31220719FFD0 H312207226B6B H312207237AE2 H312207240E5D H312207262D4F H312207314028 H31220733633A H312207341785 H31220737251E H312207432E32 H312207454B04 H312207476816 H312207522663 H3122075552DC H3122075771CE H31220881EE47 H3122095761D5 H312209630D99 H312209665A34 H31220997C875 H312208354CCB H312208376FD9 H31220842757C H31220849CBAF H312208573B09 H312208671161 H31220868E996 H312208743A22 H3122087708B9 H312209035949 H3121691135D5 H31217033A5D2 H312171480CD5 H31217176CFC3 H31220738DDE9 H312208175C69 H312208299F7F H31220869F81F H31220883CD55 H31220954534E H3119904310C5 H31200467A24A H31200537862E H312006146861 H312008735815 H31200991BBCB H312012037ADC H312022674DE5 H312058755374 H31207455FC11 H31208096B6B2 H31217042F953 H312170906A39 H31217144C6B9 H31217145D730 H31217166D61B H31217177DE4A H31220804772A H31220808BD46 H3122082002BE H3120592203AF H31217103D566 H31217147F422 H312208277601 H312208310AEF H312208526CA4 H31220919EFCB H312209983082 H31226199AC53 H3122724163BC H312272425127 H31227263731E H312272727B4F H31227280DB95 H31227293F0D6 H312273127543 H3122731722EE H31227319CB90 H312273252B94 H31227329E1F8 H31227335324C H31227386E47F H31227397EC2E H312274194795 H31227534F51C H31227562EE92 H3122756841C8 H31227577A0E7 H31227587232F H312276043010 H312276124CFE H31227623771F H3122764323CF H312276511905 H312276712AB5 H31227679A6FD H31227697D593 H312277031E73 H31227708A0A0 H31227719A8F1 H3122772548F5 H3122773663B6 H312277451C25 H31227758DE18 H31227769E5F9 H31227777155F H31227784A40C H31227785B585 H31227786871E H312277879697 H312278315DCE H31227838C00F H3122784333D4 H312278499C8E H312278702B27 H31227884EECB H31227908B0BB H31227914630F H312279389AD3 H312279436908 H3122796179AA H312279671C9C H3122797437DF H31227985A59E H31228003208F H312280089E5C H312280155C61 H31228023133F H3122803129F5 H3122804522D9 H312280524FBE H312280651169 H31228069DB05 H31228086B9E2 H31228090C50C H312280948328 H312280984944 H312281026BDA H312281040EEC H31228108C480 H312313453F9A H31231358FDA7 H31231369C646 H31231374047B H312313985407 H31231403B1C9 H31231406E664 H31231412B998 H31231421A16B H31231426D5D4 H31231430A93A H31231434EF1E H31231441F5BB H31231445B39F H31231450FDEA H3123145698DC H3123146491A6 H312314694A43 H31231472ED48 H31231474887E H312314804D92 H312314837F09 H31231488C1DA H31231500D98E H31231502FA9C H31231507AD31 H312315148672 H31231517B4E9 H31248710BC51 H31248711ADD8 H312487129F43 H312487138ECA H31248714FA75 H31248715EBFC H31248716D967 H31248717C8EE H312487183019 H312487192190 H312487209639 H3124872187B0 H312487308FE1 H31248733BD7A H31248734C9C5 H31248735D84C H31248736EAD7 H31248737FB5E H3124873803A9 H312487391220 H31248740C2E9 H31248741D360 H31248742E1FB H31248743F072 H31248752F823 H31248753E9AA H312487549D15 H312487558C9C H31248756BE07 H31248757AF8E H312487585779 H3124875946F0 H31248760F159 H31248770E881 H31248771F908 H31248772… (truncated, 7188 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 December 22, 2021

JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27482863 27532553 27602969 27652583 27723139 27758892 27796835 27846707 27899139 27966498 28021411 GTIN: 8714729953258
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 39-30-450-025 Material Number: M00573110

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27857328 GTIN: 8714729776529
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 44-30-260-035 Material Number: M00573060

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27522394 27566792 27589267 27618168 27726335 27758466 27795807 27822419 27458135 27472063 27553565 27649356 27706277 27758465 27773622 27821544 27865086 27986549 28017367 28289453 GTIN: 8714729776673
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 44-30-450-035 Material Number: M00573070

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27737251 27970819 28289451 27821545 28019275 GTIN: 8714729776543
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: M00575241 RX CHOLANGIOGRAM KIT: Lot Numbers"27879206, 28103331, 28336117 UDI: 8714729818380; M00575281 RX CHOLANGIOGRAM KIT Lot Numbers: 27803953, 27878151, 27919775 UDI: 8714729818410 M00575321 RX CHOLANGIOGRAM KIT Lot Numbers: 27955111, 28024443, 28269925 UDI: 8714729818427; M00575361 RX CHOLANGIOGRAM KIT Lot Number:28074763 UDI:8714729818458; M00575381 RX CHOLANGIOGRAM KIT Lot Numbers: 27755939, 27990502 UDI: 8714729818465; M00575401 RX CHOLANGIOGRAM KIT Lot NUmber: 28311945 UDI:8714729818472; M00575441 RX CHOLANGIOGRAM KIT Lot Numbers: 27673853, 27891176 , 28024444 UDI: 8714729818489; M00575481 RX CHOLANGIOGRAM KIT Lot Numbers: 27919776, 28060354 UDI: 8714729818496.
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Batch Numbers: 27446479 27448337 27470857 27473288 27479007 27488955 27519099 27583248 27584920 27609359 27610230 27616517 27674795 27679150 27681372 27682823 27710650 27715915 27740170 27742966 27746783 27747640 27770749 27779090 27781488 27784284 27806906 27808089 27813903 27818805 27869283 27872956 27955178 27958586 27965294 28021413 28054973 28118052 28296777 28296779 GTIN: 8714729778264
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

JAGTOME RX 49-20-260-035 Material Number: M00573000

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27690967 27949032 27604634 27692921 GTIN: 8714729121169
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

HYDRATOME RX 49-30MM/260CM Material Number: M00583010

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27641142 28045346 GTIN: 8714729755166
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

DREAMTOME 49-20MM/260CM Material Number: M00584000

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27566791 27604633 27690970 27802364 27951185 28028721 GTIN: 8714729778226
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

DREAMTOME 44-30MM/450CM Material Number: M00584070

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27625066 27805561 GTIN: 8714729778295
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

DREAMTOME 49-30MM/260CM Material Number: M00584010

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27566790 27641143 27852432 GTIN: 8714729778233
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

HYDRATOME RX 44-20MM/450CM Material Number: M00583060

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: Batch 27442309 28020415 GTIN: 8714729755210
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27463326 27468730 27553568 27590928 27629941 27684747 27764231 27794744 27837500 27931763 27986550 28058938 GTIN: 8714729778288
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 22, 2021

HYDRATOME RX 44-30MM/260CM Material Number: M00583050

Sterility of device is compromised due to a sterile barrier breach

ALL 50 STATES
Full report

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

Recall #:
89468
Lot/product code:
Lot Numbers: 27503545 27539248 27622371 27830206 27836999 27892995 27940790 GTIN: 8714729755203
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)