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Recalls affecting District of Columbia

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

16,249 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 14, 2021

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104

Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

ALL 50 STATES
Full report

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

Recall #:
89443
Lot/product code:
Lot Numbers: 50971615, 50971617 & 50967788
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 15, 2021

CURAD REUSABLE GEL HOT/COLD PACK

The product contains natural rubber latex but the label states that it does not.

ALL 50 STATES
Full report

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

Recall #:
89235
Lot/product code:
Item Numbers: 1) CUR959/CUR959H (Lots 69718070004, 69718090003, 69718100001, 69718100004, 69718110003, 69719010001, 69719030001, 69719030004, 69719040002, 69719070005, 69719080002, 69719080006, 69719090001, 69719090004, 69719100001, 69719100004, 69719110001, 69719110003, 69719110004, 69719120001, 69719120005, 69719120002, 69719120006, 69720010001, 69720020002, 69720040001, 69720050001, 69720060001, 69720060002, 69720080002, 69720090001, 69720090002, 69720100001, 69720100002, 69720110002, 69720120001, 69720120002, 69721010001, 69721020001, 69721030001, 69721030002, 69721050001, 69721050002, 69721050003, 69721060001, 69721060002, 69721070001, 69721080002, 69721090001) 2) TGT0114V1 (Lots 69718070004, 69718080002, 69718090002 , 69718100004, 69718110003, 69719010001, 69719030004, 69719040002, 69719050002, 69719050004, 69719060001, 69719060003, 69719070001, 69719070005, 69719080002, 69719080006, 69719090004, 69719100001, 69719100004, 69719100005, 69719110001, 69719110002, 69719110004, 69719110003, 69719120005, 69719120002, 69719120007, 69719120006, 69720010001, 69720070001, 69720070002, 69720080001, 69720080002, 69720100003)
Recalling firm:
MEDLINE INDUSTRIES, LP - Northfield
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 17, 2021

Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US

The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.

ALL 50 STATES
Full report

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

Recall #:
89418
Lot/product code:
UDI: 10884521812253, 07290016745047, 10884521812291 For CFN CH08-40-75US: GTIN Batch 07290016745047 21904374 07290016745047 21904432 07290016745047 22000673 07290016745047 22000709 07290016745047 22000817 07290016745047 22000880 07290016745047 22001030 07290016745047 22001061 07290016745047 22001191 07290016745047 22001310 07290016745047 22001417 07290016745047 22001448 07290016745047 22001728 07290016745047 22002086 07290016745047 22002088 10884521812253 22002498 07290016745047 22002583 10884521812253 22002603 07290016745047 22003037 07290016745047 22100003 07290016745047 22100321 07290016745047 22100322 07290016745047 22101089 07290016745047 22101090 10884521812291 22102189
Recalling firm:
Covidien Llc
View official FDA record (opens in a new tab)
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

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

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

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

DREAMTOME 49-20MM/450CM Material Number: M00584020

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: 27802363 GTIN: 8714729778240
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

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 49-20MM/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

JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

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: 27481920 27524107 27525279 27530542 27574053 27598798 27652479 27722062 27722511 27742261 27758891 27795634 27846706 27897451 27969768 28027118 28070708 GTIN: 8714729953234
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

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

NIM TRIVANTAGE EMG Endotracheal Tube

There is potential for multiple issues due to a manufacturing nonconformity.

ALL 50 STATES
Full report

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

Recall #:
89280
Lot/product code:
Products: 1) Product Number 8229705 (GTIN 00763000033934); Lots: 0218762694, 0218663943, 0219904500, 0220293429, 0220584798, 0220756285, 0220774358, 0221736070, 0221805033, 0222186741, 0222495993, 0222591367 2) Product Number 8229706 (GTIN 00763000033941); Lots: 0218663944, 0218664146, 0218762695, 0218762699, 0218762698, 0218762697, 0219010138, 0219010139, 0219010142, 0219010140, 0219010141, 0219278186, 0219272545, 0219278189, 0219278188, 0219278190, 0219444156, 0219444157, 0219278187, 0219444160, 0219444158, 0219444159, 0219444161, 0219836614, 0219972527, 0219969085, 0219972526, 0219972528, 0219836616, 0220087597, 0220087596, 0220087598, 0220293430, 0220293432, 0220293434, 0220293431, 0220293433, 0220293435, 0220371534, 0220371535, 0220371537, 0220371536, 0220517619, 0220517618, 0220584803, 0220584804, 0220734720, 0220769468, 0220769470, 0220878556, 0220769469, 0220878557, 0220934885, 0221123594, 0221123639, 0221248868, 0221248867, 0221248869, 0221493241, 0221543453, 0221543452, 0221637121, 0221637122, 0221710524, 0221805030, 0221805031, 0221805039, 0221805041, 0222048142, 0222024594, 0222057391, 0222140123, 0222200982, 0222200983, 0222200984, 0222239875, 0222239874, 0222352848, 0222396630, 0222428754, 0222465659, 0222495994, 0222495995, 0222495996, 0222542347, 0222542348, 0222563000, 0222563288, 0222738659, 0222719941, 0222684388 3) Product Number 8229707 (GTIN 00763000033958); Lots: 0218664151, 0218664148, 0218664149, 0218664157, 0218664156, 0218664155, 0218664150, 0218664154, 0218664158, 0218664153, 0218664152, 0218762700, 0218762705, 0218762701, 0218762704, 0218762703, 0218762806, 0218762702, 0218762807, 0218762812, 0218762809, 0218762814, 0218762815, 0219010143, 0219010144, 0219010145, 0219010806, 0219010807, 0219010809, 0219010813, 0219010811, 0219010810, 0219010808, 0219010812, 0219010814, 0219010816, 0219010818, 0219010819, 0219010817, 0219010820, 0219010815, 0219010821, 0219010822, 0219278191, 0219444374, 0219444375, 0219444376, 0219278193, 0219278196, 0219278195, 0219278192, 0219278197, 0219278194, 0219444369, 0219444370, 0219278198, 0219444371, 0219952959, 0219444372, 0219985176, 0219444373, 0219985177, 0219723502, 0219952958, 0220033883, 0220033885, 0220037915, 0220047459, 0220047460, 0220057008, 0220057009, 0220057010, 0220057011, 0220076607, 0220081032, 0220081037, 0220008824, 0220008823, 0220010546, 0220010547, 0220008825, 0220010548, 0220087591, 0220087602, 0220087599, 0220087601, 0220087600, 0220087603, 0220142052, 0220087886, 0220142053, 0220142054, 0220142055, 0220142060, 0220149776, 0220149778, 0220230467, 0220230468, 0220230472, 0220230469, 0220142057, 0220142058, 0220142059, 0220149779, 0220142063, 0220142064, 0220142062, 0220142065, 0220370784, 0220370785, 0220371526, 0220371528, 0220371527, 0220371530, 0220371529, 0220371531, 0220371532, 0220371533, 0220517189, 0220517190, 0220517620, 0220517621, 0220517191, 0220517193, 0220517194, 0220517192, 0220517195, 0220517196, 0220517197, 0220517199, 0220517200, 0220517198, 0220517201, 0220517202, 0220622252, 0220622253, 0220637407, 0220637408, 0220637409, 0220637410, 0220688264, 0220688265, 0220691509, 0220691510, 0220734718, 0220756281, 0220756282, 0220756283, 0220756284, 0220769471, 0220804919, 0220769472, 0220798476, 0220813969, 0220813970, 0220817687, 0220817686, 0220826216, 0220826217, 0220845825, 0220846126, 0220857889, 0220878558, 0220878559, 0220878561, 0220878560, 0220878562, 0220878563, 0220913062, 0220935486, 0220935487, 0220935488, 0220935489, 0220974382, 0221040035, 0221056071, 0221040036, 0221056072, 0221082044, 0221069155, 0221082126, 0221073627, 0221090328, 0221090327, 0221097604, 0221097605, 0221098067, 0221098066, 0221118571, 0221118572, 0221123591, 0221123638, 0221146333, 0221146457, 0221146458, 0221146460, 0221146459, 0221146461, 0221146462, 0221146463, 0221146879, 0221146889, 0221146901, 0221248875, 0221248876, 0221248877, 0221248878, 0221248879, 0221248880, 0221248881, 0221248882, 0221248883, 0221248884, 0221248885, 0221378722, 0221378724, 0221378725, 0221379386, 0221379387, 0221379388, 0221493665, 0221493866, 0221514981, 0221526915, 0221526917, 0221526918, 0221526920, 0221526919, 0221571421, 0221599118, 0221599117, 0221599181, 0221599119, 0221651974, 0221637118, 0221656119, 0221656118, 0221659143, 0221659144, 0221736003, 0221736005, 0221766209, 0221766208, 0221766211, 0221736786, 0221805043, 0221772984, 0221886337, 0221805044, 0221893434, 0221893435, 0221897719, 0221897720, 0221893433, 0221924396, 0221931540, 0221938902, 0221938901, 0221962166, 0221967955, 0222057392, 0222024589, 0222069694, 0222093329, 0222069692, 0222069693, 0222093330, 0222101075, 0222110921, 0222110922, 0222136940, 0222106107, 0222139599, 0222139600, 0222140118, 0222140119, 0222140125, 0222140446, 0222163047, 0222140120, 0222168488, 0222168489, 0222168491, 0222168492, 0222168493, 0222202227, 0222202226, 0222202228, 0222202230, 0222202231, 0222239881, 0222202232, 0222239878, 0222239882, 0222239883, 0222239884, 0222240046, 0222240047, 0222239885, … (truncated, 9812 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Xomed, Inc.
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

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)
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

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 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

HYDRATOME RX 44-20MM/260CM Material Number: M00583040

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: 27439836 27440919 27493069 27496980 27499896 27750785 27753215 27825981 27879216 27880741 27931764 27934862 28032489 28043447 GTIN: 8714729755197
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)