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Recalls affecting Maryland

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

16,861 recalls found
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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

▸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

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 September 29, 2021

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

ALL 50 STATES
▸Full report

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

Recall #:
88648
Lot/product code:
Serial Numbers: 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(truncated, 5904 characters total — see the official FDA record for the full value)
Recalling firm:
CooperSurgical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 30, 2021

MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.

Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

ALL 50 STATES
▸Full report

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

Recall #:
88868
Lot/product code:
Saline DV Breast Implant Codes with lots manufactured impacted by the Recall Product Code/UDI GTIN Code: 3501610/81317001171 Lot Numbers: 9528016 9558223 3501620/81317001195 Lot Numbers: 9576451 9574053 9574859 3501625/81317001201 Lot Numbers: 9539273 9549488 9567250 9583791 9585571 9584309 9587067 3501630/81317001218 Lot Numbers: 9534032 9538574 9546472 9556176 9570169 9570471 9572394 9611046 9611964 9611603 9622517 3501635/81317001225 Lot Numbers: 9529384 9531109 9540916 9544819 9535775 9553669 9552230 9568916 9566957 9565272 9575831 9617819 3501640/81317001232 Lot Numbers: 9533837 9537342 9534030 9534353 9545543 9553337 9550675 9555186 9580874 9583024 9583793 9590274 9592612 9614775 9617814 9614478 3501645/81317001249 Lot Numbers: 9530917 9531112 9535132 9540919 9546777 9550164 9550487 9547976 9549490 9559882 9578300 9580414 9582184 9583026 9582572 9631722 9629900 3501650/81317001256 Lot Numbers: 9529112 9534355 9527435 9542799 9550485 9553671 9553110 9573299 9576971 9576298 9574861 9577403 9576683 9587327 9590029 9589074 9611045 9611601 9629494 3501655/81317001263 Lot Numbers: 9535386 9539275 9547111 9553108 9555184 9555923 9569246 9557445 9597482 9600888 9603191 9598143 9605660 9607486 3501660/81317001270 Lot Numbers: 9533291 9528580 9537339 9553339 9558222 9559143 9561193 9582182 9583025 9591674 9611963 9614772 9614480 9614774 9615516 3501670/81317001287 Lot Numbers: 9527187 9528578 9538081 9542801 9547114 9561195 9567890 9559141 9595692 9597741 9615898 9619996 3501680/81317001294 Lot Numbers: 9530517 9545545 9562724 9584036 9585573 9615518 3501685/81317001300 Lot Numbers: 9541786 9546779 9555187 9574051 9616933 3501690/81317001317 Lot Numbers: 9543357 9547972 9602499 9602765 3501695/81317001324 Lot Numbers: 9544816 9552232 9563943 3502200/81317001355 Lot Numbers: 9532948 9550672 9607487 9611604 3502225/81317001362 Lot Numbers: 9550484 9553670 9595693 9596802 9596397 9598144 3502250/81317001379 Lot Numbers: 9535133 9539276 9551037 9555185 9547973 9550165 9584310 9586121 9604456 9599498 3502275/81317001386 Lot Numbers: 9530516 9533839 9535387 9541225 9550674 9547975 9576452 9576296 9576970 9578064 9608063 9608403 9608792 9612273 3502300/81317001393 Lot Numbers: 9530520 9535778 9536100 9541463 9546473 9561861 9563096 9564279 9565713 9564913 9569248 9589073 9589650 9592613 9592326 9606471 9614988 9615519 9629493 3502325/81317001409 Lot Numbers: 9526975 9528017 9528840 9529386 9530916 9541788 9557442 9555926 9569687 9570166 9571639 9570470 9573063 9578066 9576684 9577401 9596800 9597739 9615895 3502350/81317001416 Lot Numbers: 9530518 9535773 9533290 9535131 9536098 9541227 9546471 9552229 9553109 9556177 9555924 9573300 9570168 9570472 9571641 9572393 9587065 9587328 9589652 9591673 9594299 9606470 9614773 9614987 9610033 9608402 9614989 3502375/81317001423 Lot Numbers: 9544817 9546175 9546177 9550163 9556606 9554350 9555922 9556604 9553338 9567249 9568915 9569689 9584308 9585572 9598142 9599496 9600886 9608064 9625685 9624985 3502400/81317001430 Lot Numbers: 9529875 9538082 9541466 9541784 9545544 9549491 9554347 9563941 9564916 9562722 9592611 9615896 9616495 9617818 3502425/81317001447 Lot Numbers: 9530519 9534033 9538572 9543627 9551034 9559144 9559516 9563098 9567889 9611044 9611600 9612274 9614477 9632676 3502450/81317001454 Lot Numbers: 9531110 9543358 9546178 9553668 9558850 9568917 9569245 9571293 9571640 9570473 9573298 9602500 9603190 9606468 9611602 3502475/81317001461 Lot Numbers: 9540917 9537341 9554349 9567891 9569247 9602497 9603192 9608794 3502500/81317001478 Lot Numbers: 9538080 9543990 9547112 9558851 9558853 9559518 9589651 9590028 9594298 9608795 9610037 9606469 9626607 3502550/81317001485 Lot Numbers: 9532946 9553111 9556175 9557444 9594296 9595426 9596092 9612272 9616497 3502600/81317001492 Lot Numbers: 9535385 9583792 9586122 9587326 9612275 9616499 3502650/81317001508 Lot Numbers: 9538083 9551039 9614479 9615517 3502700/81317001515 Lot Numbers: 9567892 9586783 9588332 9620460 3502750/81317001522 Lot Numbers: 9573064 9576297 9574860 3502800/81317001539 Lot Numbers: 9528841 9525967 9528839 9527436 9550486 9561863 9563939 9565271 9566958 9565269 9564915 9571295 9575830 9630358 9629166 3503210/81317001584 Lot Numbers: 9567251 9595691 3503230/81317001591 Lot Number: 9574052 3503250/81317001607 Lot Numbers: 9545546 9565270 9591675 9608404 9610036 9610034 3503270/81317001614 Lot Numbers: 9541783 9558224 9555925 9611048 9613076 3503290/81317001621 Lot Numbers: 9530727 9541462 9543989 9563095 9561862 9565714 9562723 9559881 3503310/81317001638 Lot Numbers: 9527434 9543628 9538573 9563942 9529385 9582571 9584035 9590027 9602498 9602766 3503330/81317001645 Lot Numbers: 9529113 9529874 9532947 9528015 9541228 9536101 9542800 9552231 9561194 9558852 9559517 9559142 9578299 9580873 9582861 9580875 9582183 9584037 9590273 9588333 9586784 9587066 9616932 9617100 3503380/81317001652 Lot Numbers: 9533838 9530728 9534031 9535776 9540918 9544818 9546778 9550… (truncated, 6220 characters total — see the official FDA record for the full value)
Recalling firm:
Mentor Texas, LP.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2021

SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; SC 1409/PGI Supercore 14GA x 9CM; SC 1609/PGI Supercore 16GA x 9CM; SC 1806/PGI Supercore 18GA x 6CM;

Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.

ALL 50 STATES
▸Full report

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

Recall #:
88814
Lot/product code:
REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; Lot Numbers: 11364350 11365643 11368388 11371872 11374998 11376772 11378864 11382837 11385962 11389848 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; Lot Numbers: 11368389; 11376773; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; Lot Numbers: 11362716; 11363320; 11365935; 11377634; 11381340; 11384192; 11388461; 11388552; 11389139; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; Lot Numbers: 11361702; 11365788; 11371012; 11374235; 11376598; 11379722; 11382768; 11383890; 11388656; 11389138; 701118090/SUPERCORE BIOPSY INSTR 18GA X 9CM; Lot Numbers: 11362759; 11363229; 11364420; 11367439; 11370106; 11372917; 11376074; 11377430; 11378217; 11383193; 11383785; 11384243; 11387238; 11388864; 701118150/SUPERCORE BIOPSY INSTR 18GA X 15CM; Lot Numbers: 11370107; 11375663; 11377819; 11382602; 11385139; 11385965; 11389140; 11390503; 701118200/SUPERCORE BIOPSY INSTR 18GA X 20CM; Lot Numbers: 11372225; 11374410; 11377431; 11384193; 11388505; 701120090/SUPERCORE BIOPSY INSTR 20GA X 9CM; Lot Numbers: 11374411; 11378865; 11383280; 701120150/SUPERCORE BIOPSY INSTR 20GA X 15CM; Lot Numbers: 11366252 11367440; 11376374; 11377820; 11381387; 11385960; 701120200/SUPERCORE BIOPSY INSTR 20GA X 20CM; Lot Numbers: 11366253; 11380018; 11388893; 701214090/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 9CM; Lot Numbers: 11369916; 11378293; 11383587; 11387065; 701214150/SUPERCORE BIOPSY INSTR W/COAXIAL - 14G x 15CM; Lot Numbers: 11377967; 11382843; 701216090/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 9CM; Lot Numbers: 11364421; 11367443; 11374684; 11379724; 11385966; 11388551; 701216150/SUPERCORE BIOPSY INSTR W/COAXIAL - 16G x 15CM; Lot Numbers: 11382845; 11388550; 11390251; 701218090/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 9CM; Lot Numbers: 11361701; 11364247; 11367445; 11372366; 11374807; 11378687; 11383192; 11383784; 11388286; 701218150/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 15CM; Lot Numbers: 11371404; 11373084; 11377636; 11380993; 11383194; 11383195; 11387400; 11387833; 11390504; 701218200/SUPERCORE BIOPSY INSTR W/COAXIAL - 18G x 20CM; Lot Numbers: 11366315; 11372227; 11377432; 11381193; 11382998; 11384716; 701220090/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 9CM; Lot Numbers: 11367446; 11370574; 11375664; 11380589; 11381572; 11388507; 701220150/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 15CM; Lot Numbers: 11368750; 11371876; 11372228; 11376375; 11377429; 11380104; 11384717; 11387148; 701220200/SUPERCORE BIOPSY INSTR W/COAXIAL - 20G x 20CM; Lot Numbers: 11362655; 11363516; 11372322; 11378295; 11380103; 11382884; 11387584; 701114090M/SUPERCORE BIOPSY INSTR 14GA X 9CM-MAMMOTOME; Lot Numbers: 11371356; 11382375; 11389615; 701114150M/SUPERCORE BIOPSY INSTR 14GA X 15CM-MAMMOTOME; Lot Number: 11371357; 701116090M/SUPERCORE BIOPSY INSTR 16GA X 9CM-MAMMOTOME; Lot Number: 11371359; SC 1409/PGI Supercore 14GA x 9CM; Lot Numbers: 11370550; 11384881; SC 1609/PGI Supercore 16GA x 9CM; Lot Number: 11370552; SC 1806/PGI Supercore 18GA x 6CM; Lot Numbers: 11375600; 11364469;
Recalling firm:
Argon Medical Devices, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 5, 2021

Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs

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

Recall #:
88870
Lot/product code:
Serial Numbers: 15916 15908 103108 103111 15917 103047 103048 103171 103181 103182 103185 103191 103193 103301 103170 103223 103225 103247 15939 103313 103315 100413 100414 100417 100402 14612 14613 101016 101017 101019 101020 101022 101029 101031 101032 101036 18903 15945 15946 103359 15931 100263 103424 15953 103274 15941 15942 103319 103320 103321 103323 103325 103328 103330 103333 103334 103335 103344 100216 103337 15514 15515 100154 100156 100157 14803 14804 18502 15544 15545 100416 102008 103413 15561 101082 101083 101084 18902 14603 100208 100209 102138 103437 15560 101090 102019 102021 102025 102029 15559 101088 15819 15820 102145 102147 103160 15539 100346 100349 103314 102199 15830 102323 102324 102325 15832 15833 103079 122042 123004 15005 15147 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 122006 122026 102214 102216 102219 102222 102272 101096 102181 102242 102068 102069 102078 102080 102093 102097 15828 15829 102221 103123 103124 103131 100163 100165 15135 15136 100306 100309 15552 15553 101045 101052 101053 101054 101056 101059 101063 101064 103300 15564 15565 101099 101100 101101 15556 15557 101060 101068 101069 101070 101071 101072 103265 14602 100064 15546 14611 100422 14906 103307 103312 103019 10654 11657 14122 14123 103331 103362 103393 103402 103419 103252 103261 103267 103269 103270 103276 103277 103280 103281 103022 100279 103381 15543 15551 100408 100410 100411 100412 101043 102162 122029 103194 103145 103148 103152 15920 15537 15538 100345 123047 15836 15837 102285 102286 102338 102183 15943 15948 103345 103368 103415 103416 123053 15123 103245 103249 103250 103264 15949 15904 103080 103082 103086 103088 103089 103090 15530 100231 103290 15804 102030 102031 102304 101094 18600 15547 15548 101008 101093 15821 15523 100175 100176 102226 101097 15935 15936 103306 103341 15909 102269 102273 102276 102278 102279 103114 14809 14810 102283 15823 15824 102193 15803 15809 15506 15507 100070 100071 100074 102155 102157 15902 15903 103040 103042 14312 103039 15009 102174 102182 15813 15814 103130 103200 103234 103053 14900 103116 103117 103119 103288 18900 18901 14902 15927 15928 14802 15901 103008 103216 102237 103189 103208 15541 100391 15536 102010 15841 15842 102295 102296 102302 18099 100006 18098 14299 100005 10731 15524 15525 100184 15950 103352 122011 102274 14905 103283 15937 15938 103308 103310 15925 15926 103115 103244 103246 103014 15923 15924 103242 101018 121014 15818 102143 102091 Expanded Recall 10/27/21 (36 units) Serial Numbers: 15915 103137 103144 103196 103198 15913 103166 103173 123021 103184 103177 103186 103199 103139 103168 102326 103167 103178 103161 103172 14120 103432 102328 15520 15522 102060 102062 15807 15806 102057 102049 102051 103431 101095 101089 15558
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 6, 2021

Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038

The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.

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

Recall #:
88865
Lot/product code:
UDI 00630414596754
Recalling firm:
Siemens Healthcare Diagnostics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 7, 2021

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

Mislabeled product.

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

Recall #:
90281
Lot/product code:
Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767
Recalling firm:
SCIENCE & BIO MATERIALS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

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

Recall #:
88826
Lot/product code:
LOT#: 6000842, 6002045, 6011609, 6034238, 6040517, 6042907. UDI: " Primary: 00886158000594 " Secondary: 30886158000595 " Tertiary: 50886158000599
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

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

Recall #:
88826
Lot/product code:
Lot Number 6018382
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

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

Recall #:
88826
Lot/product code:
Lot Numbers 6032947 and 6033588 UDI: " Primary: 00886158019961 " Secondary: 30886158019962 " Tertiary: 50886158019966
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2021

bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

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

Recall #:
88826
Lot/product code:
Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834
Recalling firm:
Beaver Visitec International, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 11, 2021

Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100; Proslate 8: B398PS080; Proslate 4: B398PS040)

Warning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other property

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

Recall #:
89134
Lot/product code:
All units
Recalling firm:
Forbes Rehab Services Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 12, 2021

Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7); 11. CUSTOM PACK BB8B09R8 INFANT (Model BB8B09R8); 12. CUSTOM PACK BB8D40R3 P3/16X1/4 (Model BB8D40R3); 13. CUSTOM PACK BB8Q16R PED ART (Model BB8Q16R); 14. CUSTOM PACK BB8V01R8 FVDL COLM (Model BB8V01R8); 15. CUSTOM PACK HY2V10R33 ADULT (Model HY2V10R33); 16. CUSTOM PACK HY3Z71R17 PRIMARY (Model HY3Z71R17); 17. CUSTOM PACK HY3Z71R18 PRIMARY (Model HY3Z71R18); 18. CUSTOM PACK HY4V00R24 ADULT (Model HY4V00R24); 19. CUSTOM PACK HY6X29R12 CON-SUPP (Model HY6X29R12); 20. CUSTOM PACK HY8L14R7 HYBRID (Model HY8L14R7); 21. CUSTOM PACK HY8P36R6 CPS (Model HY8P36R6); 22. CUSTOM PACK HY8V01R6 FVDL COLM (Model HY8V01R6); 23. CUSTOM PACK HY9D36R1 HL PUMP P (Model HY9D36R1); 24. CUSTOM PACK HY9L07R4 ADLT FUS (Model HY9L07R4); 25. CUSTOM PACK HY9L80R4 SADT FUS (Model HY9L80R4); 26. CUSTOM PACK HY9M47R6 ADLT MAIN (Model HY9M47R6); 27. CUSTOM PACK HY9N38R4 VGH FUS (Model HY9N38R4); 28. CUSTOM PACK HY9R26R12 CENT (Model HY9R26R12); 29. PERFUSION M337112Q 1/B (Model M337112Q); 30. PERFUSION M344130B 1/B (Model M344130B); 31. PERFUSION M392419C 1/B (Model M392419C); 32. PERFUSION M394213B 1/B (Model M394213B); 33. PERFUSION M394213C 1/B (Model M394213C); 34. PERFUSION M490124D 1/B (Model M490124D); 35. PERFUSION M491335A 1/B (Model M491335A); 36. PERFUSION M499709E 1/B (Model M499709E); 37. PERFUSION M960164F 1/B (Model M960164F); 38. PERFUSION M960165E 1/B (Model M960165E); 39. PERFUSION M960169E 1/B (Model M960169E); 40. PERFUSION M960462C 1/B (Model M960462C); 41. PERFUSION M960462D 1/B (Model M960462D); 42. PERFUSION M960463D 1/B (Model M960463D); 43. PERFUSION M960466D 1/B (Model M960466D); 44. CUSTOM PACK TL4K33R3 FCI ADULT (Model TL4K33R3); 45. CUSTOM PACK TL4K95R12 PERFNPLEG (Model TL4K95R12); 46. CUSTOM PACK TL6C91R5 SELLKE PK (Model TL6C91R5); 47. CUSTOM PACK TL6G48R9 ST PAULS (Model TL6G48R9); 48. CUSTOM PACK TL7X09R3 FCVC ADLT (Model TL7X09R3);

Product is labeled as non-pyrogenic but endotoxin testing was not performed.

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

Recall #:
88932
Lot/product code:
Medtronic Perfusion Kits: 1. Model BB10Q85R, (a) GTIN 00763000343057, Lot Numbers: 219164410, 220219784, 220822136, 222227252; (b) GTIN 20763000343068, Lot Numbers: 219822381, 220104257 2. Model BB11C01R, GTIN 00763000312190, Lot Numbers: 218556144, 218790882, 219012584, 219586019 3. Model B7H95R22, GTIN 00763000250904, Lot Numbers: 219586008, 220075503, 220476338 4. Model BB7H95R25, GTIN 00763000451738, Lot Numbers: 221406421 5. Model BB7H99R22, GTIN 00763000250911, Lot Numbers: 219814395, 219886115, 220143946, 220257643, 220434398 6. Model BB7P46R4, GTIN 00643169380967, Lot Numbers: 218503747, 219975261, 220383910, 221017404, 221148797 7. Model BB7P48R4, GTIN 00643169379848, Lot Numbers: 219073386 8. Model BB7W03R8, GTIN 00643169990562, Lot Numbers: 219107651, 219491297, 221590546 9. Model BB7W80R7, GTIN 00763000344535, Lot Numbers: 219380830, 219600017, 222304697, 222400044 10. Model BB8B09R7, GTIN 00763000307189, Lot Numbers: 218613111 11. Model BB8B09R8, GTIN 00763000347574, Lot Numbers: 219291877, 219529760, 219663957, 220095395, 220476333, 221148863, 221765951, 222227240, 222469109 12. Model BB8D40R3, GTIN 00643169655461, Lot Numbers: 219220652, 219482298 13. Model BB8Q16R, GTIN 00643169549364, Lot Numbers: 218657286, 221451556 14. Model BB8V01R8, GTIN 00763000411312, Lot Numbers: 221267645 15. Model HY2V10R33, GTIN 00763000299835, Lot Numbers: 219165752, 220104314 16. Model HY3Z71R17, GTIN 00763000241551, Lot Numbers: 219073460 17. Model HY3Z71R18, GTIN 00763000353728, Lot Numbers: 219435852, 220219913, 220911962 18. Model HY4V00R24, GTIN 00763000082451, Lot Numbers: 219115980, 219436006, 219975242, 220383867 19. Model HY6X29R12, GTIN 00763000280833, Lot Numbers: 218912023, 219061258, 219061259, 219061260, 219390708, 220075525, 220075526, 220281424, 220434431 20. Model HY8L14R7, GTIN 00763000353360, Lot Numbers: 220075494 21. Model HY8P36R6, GTIN 00763000097165. Lot Numbers: 219291532 22. Model HY8V01R6, GTIN 00763000025465, Lot Numbers: 218557263, 218901885 23. Model HY9D36R1, GTIN 00643169855465, Lot Numbers: 219291881, 219291882, 219291883, 219682010, 220144062, 220144063, 220383952, 220383953, 220383954 24. Model HY9L07R4, GTIN 00763000093495, Lot Numbers: 219237962 25. Model HY9L80R4, GTIN 00763000092603, Lot Numbers: 220104289 26. Model HY9M47R6, GTIN 00763000175634, Lot Numbers: 219165837, 219165838, 219452417, 219452418, 220295056, 220295059 27. Model HY9N38R4, GTIN 00643169985148, Lot Numbers: 219061189, 219390629, 220383876, 220954138 28. Model HY9R26R12, GTIN 00763000317942, Lot Numbers: 218790663, 219343932, 219401495, 220337254, 220866450, 220866451 29. Model M337112Q, GTIN 00763000242824, Lot Numbers: 219983643, 219984266, 221053657, 221206757, 221452447, 221516971 30. Model M344130B, GTIN 00643169946415, Lot Numbers: 218419494, 218419495, 220815603, 220883905, 221971754 31. Model M392419C, GTIN 00763000343095, Lot Numbers: 219179139, 220224289, 220637117, 221383886 32. Model M394213B, GTIN 00643169546417, Lot Numbers: 218544365, 218544407 33. Model M394213C, GTIN 00763000446437, Lot Numbers: 221309293, 222084799 34. Model M490124D, GTIN 00763000527471, Lot Numbers: 222060635 35. Model M491335A, GTIN 00763000372187, Lot Numbers: 219712665, 220479358 36. Model M499709E, GTIN 00643169713420, Lot Numbers: 219495811 37. Model M960164F, GTIN 00763000300128, Lot Numbers: 218616224, 218616225, 219868444, 22280711 38. Model M960165E, GTIN 00763000139445, Lot Numbers: 218551983, 218728458, 218728459, 222107381 39. Model M960169E, GTIN 00763000139421, Lot Numbers: 218517966, 220900240, 222047414, 222410763 40. Model M960462C, GTIN 00643169957015, Lot Numbers: 218953465 41. Model M960462D, GTIN 00763000399344, Lot Numbers: 220172291 42. Model M960463D, GTIN 00763000234775. Lot Numbers: 218483662, 218517778, 218742946, 218742949, 220729353, 220801827, 220867180, 220950181, 221143520, 221618074, 221875985 43. Model M960466D, GTIN 00763000090494, Lot Numbers: 219874178 44. Model TL4K33R3, GTIN 00613994288622, Lot Numbers: 220197637 45. Model TL4K95R12, GTIN 00763000247867, Lot Numbers: 219061229, 220383926 46. Model TL6C91R5, GTIN 00643169343641, Lot Numbers: 219435870 47. Model TL6G48R9, GTIN 00763000367909, Lot Numbers: 220004241, 220004242, 220326313, 220911952, 220911998 48. Model TL7X09R3, GTIN 00643169455115, Lot Numbers: 219107641, 219107642, 221000547
Recalling firm:
Medtronic Perfusion Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 12, 2021

Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF; Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1. Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1.

The processing of collected episode data may fail due to a software error.

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

Recall #:
88907
Lot/product code:
Application software lower than v5.0.0.
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled October 12, 2021

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets

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

Recall #:
D-0092-2022
Lot/product code:
Lot #: 163935, Exp: 10/31/2022
Recalling firm:
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 13, 2021

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.

Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

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

Recall #:
89104
Lot/product code:
RPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615
Recalling firm:
Cook Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 13, 2021

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

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

Recall #:
88930
Lot/product code:
Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

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

Recall #:
88840
Lot/product code:
Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G3108401; G3114959 (01)04562122959841(11)210524(21)G3114959
Recalling firm:
FujiFilm Healthcare Americas Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

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

Recall #:
88840
Lot/product code:
Serial Numbers/UDI: 20514657 (01)04562122958868(11)161220(21)20514657; 20659147 (01)04562122958868(11)20181124(21)20659147; 20659148 (01)04562122958868(11)20181124(21)20659148; 20659149 (01)04562122958868(11)20181124(21)20659149; 20659150 (01)04562122958868(11)20181124(21)20659150; 20659153 (01)04562122958868(11)20181126(21)20659153; 20659154 (01)04562122958868(11)20181126(21)20659154; 20659155 (01)04562122958868(11)20181126(21)20659155; 20659156 (01)04562122958868(11)20181126(21)20659156; 205G0225 (01)04562122958868(11)20170418(21)205G0225; 205G0226 (01)04562122958868(11)20170424(21)205G0226; 205P2146 (01)04562122958868(11)20170615(21)205P2146; 205P2147 (01)04562122958868(11)20170615(21)205P2147; 205P2148 (01)04562122958868(11)20170615(21)205P2148; 205P2149 (01)04562122958868(11)20170615(21)205P2149; 205Q0809 (01)04562122958868(11)20170707(21)205Q0809; 205Q0810 (01)04562122958868(11)20170707(21)205Q0810; 205Q0812 (01)04562122958868(11)20170707(21)205Q0812; 205Q0815 (01)04562122958868(11)20171006(21)205Q0815; 205T7139 (01)04562122958868(11)20171006(21)205T7139; 205T7143 (01)04562122958868(11)20171026(21)205T7143; 205V5544 (01)04562122958868(11)20171026(21)205V5544; 205V5545 (01)04562122958868(11)20171030(21)205V5545; 205V5547 (01)04562122958868(11)20171031(21)205V5547; 205V5548 (01)04562122958868(11)20171031(21)205V5548; G3005239 (01)04562122958868(11)20190308(21)G3005239; G3005240 (01)04562122958868(11)20190308(21)G3005240; G3025041 (01)04562122958868(11)20190603(21)G3025041; G3025042 (01)04562122958868(11)20190604(21)G3025042; G3025044 (01)04562122958868(11)20190605(21)G3025044; G3025045 (01)04562122958868(11)20190605(21)G3025045; G3025048 (01)04562122958868(11)20190606(21)G3025048; G3025049 (01)04562122958868(11)20190606(21)G3025049; G3037183 (01)04562122958868(11)20190624(21)G3037183; G3037184 (01)04562122958868(11)20190624(21)G3037184; G3037192 (01)04562122958868(11)20190709(21)G3037192; G3043580 (01)04562122958868(11)20190820(21)G3043580; G3043581 (01)04562122958868(11)20190820(21)G3043581; G3043582 (01)04562122958868(11)20190820(21)G3043582; G3052217 (01)04562122958868(11)20191016(21)G3052217; G3052218 (01)04562122958868(11)20191016(21)G3052218; G3052225 (01)04562122958868(11)20191202(21)G3052225; G3052234 (01)04562122958868(11)20200128(21)G3052234; G3052236 (01)04562122958868(11)20200109(21)G3052236; G3054831 (01)04562122958868(11)20200115(21)G3054831; G3054833 (01)04562122958868(11)20191212(21)G3054833; G3054840 (01)04562122958868(11)20200115(21)G3054840; G3080616 (01)04562122958868(11)20201215(21)G3080616; G3080617 (01)04562122958868(11)20201215(21)G3080617; G3106256 (01)04562122958868(11)20210413(21)G3106256; G3106258 (01)04562122958868(11)20210413(21)G3106258; G3111572 (01)04562122958868(11)20210413(21)G3111572; G3111573 (01)04562122958868(11)20210421(21)G3111573
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual

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

Recall #:
88849
Lot/product code:
Serial Numbers/UDI: G3024453 (01)04562122959278(11)191029(21)G3024453 G3024456 (01)04562122959278(11)191029(21)G3024456 G3042466 (01)04562122959278(11)191115(21)G3042466 G3042471 (01)04562122959278(11)191115(21)G3042471 G3042477 (01)04562122959278(11)191115(21)G3042477 G3042478 (01)04562122959278(11)191115(21)G3042478 G3042484 (01)04562122959278(11)191115(21)G3042484 G3042486 (01)04562122959278(11)191115(21)G3042486 G3042487 (01)04562122959278(11)191115(21)G3042487 G3042496 (01)04562122959278(11)191115(21)G3042496 G3042499 (01)04562122959278(11)191115(21)G3042499 G3042501 (01)04562122959278(11)191115(21)G3042501 G3042576 (01)04562122959278(11)191220(21)G3042576 G3042578 (01)04562122959278(11)191220(21)G3042578 G3042583 (01)04562122959278(11)191220(21)G3042583 G3042584 (01)04562122959278(11)191205(21)G3042584 G3042585 (01)04562122959278(11)191205(21)G3042585 G3042587 (01)04562122959278(11)191205(21)G3042587 G3042588 (01)04562122959278(11)191220(21)G3042588 G3082956 (01)04562122959278(11)200929(21)G3082956 G3085640 (01)04562122959278(11)200929(21)G3085640 G3085644 (01)04562122959278(11)200929(21)G3085644 G3095193 (01)04562122959278(11)201211(21)G3095193 G3095194 (01)04562122959278(11)201211(21)G3095194 G3095195 (01)04562122959278(11)201211(21)G3095195 G3095197 (01)04562122959278(11)201211(21)G3095197 G3095202 (01)04562122959278(11)201211(21)G3095202 G3095445 (01)04562122959278(11)201228(21)G3095445 G3111596 (01)04562122959278(11)210401(21)G3111596 G3111597 (01)04562122959278(11)210401(21)G3111597 G3111598 (01)04562122959278(11)210401(21)G3111598 G3111605 (01)04562122959278(11)210402(21)G3111605 G3111606 (01)04562122959278(11)210402(21)G3111606 G3114264 (01)04562122959278(11)210428(21)G3114264 G3114267 (01)04562122959278(11)210428(21)G3114267 G3114366 (01)04562122959278(11)210514(21)G3114366 G3114368 (01)04562122959278(11)210514(21)G3114368 G3114372 (01)04562122959278(11)210517(21)G3114372 G3114373 (01)04562122959278(11)210517(21)G3114373 G3114376 (01)04562122959278(11)210517(21)G3114376 G3114379 (01)04562122959278(11)210517(21)G3114379 G3114399 (01)04562122959278(11)210518(21)G3114399 G3114897 (01)04562122959278(11)210519(21)G3114897 G3114902 (01)04562122959278(11)210519(21)G3114902 G3118967 (01)04562122959278(11)210528(21)G3118967 G3118968 (01)04562122959278(11)210528(21)G3118968
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.

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▸Full report

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

Recall #:
88840
Lot/product code:
Serial Numbers: 205W3386 (01)04562122958974(11)171114(21)205W3386; 206F7900 (01)04562122958974(11)180926(21)206F7900; 206F7901 (01)04562122958974(11)180926(21)206F7901; 206F7936 (01)04562122958974(11)181113(21)206F7936; 206F7937 (01)04562122958974(11)181113(21)206F7937; 206F7940 (01)04562122958974(11)181113(21)206F7940; 206F7941 (01)04562122958974(11)181113(21)206F7941; 206F7942 (01)04562122958974(11)181113(21)206F7942; 206F7944 (01)04562122958974(11)181113(21)206F7944; 206F7945 (01)04562122958974(11)181113(21)206F7945; 206F7946 (01)04562122958974(11)181113(21)206F7946; 206F7947 (01)04562122958974(11)181114(21)206F7947; G3002552 (01)04562122958974(11)20190115(21)G3002552; G3024545 (01)04562122958974(11)190607(21)G3024545; G3037885 (01)04562122958974(11)20190719(21)G3037885; G3037887 (01)04562122958974(11)20190719(21)G3037887; G3042405 (01)04562122958974(11)190829(21)G3042405; G3042823 (01)04562122958974(11)20190807(21)G3042823; G3042828 (01)04562122958974(11)20190808(21)G3042828; G3045094 (01)04562122958974(11)20190822(21)G3045094; G3052105 (01)04562122958974(11)20191008(21)G3052105 G3052118 (01)04562122958974(11)20191025(21)G3052118 G3055549 (01)04562122958974(11)20191118(21)G3055549 G3055550 (01)04562122958974(11)20191118(21)G3055550 G3055552 (01)04562122958974(11)20191118(21)G3055552 G3055553 (01)04562122958974(11)20191118(21)G3055553 G3055554 (01)04562122958974(11)20191118(21)G3055554 G3055555 (01)04562122958974(11)20191118(21)G3055555 G3060234 (01)04562122958974(11)20191206(21)G3060234 G3060254 (01)04562122958974(11)20191206(21)G3060254 G3060275 (01)04562122958974(11)20191216(21)G3060275 G3060278 (01)04562122958974(11)20191216(21)G3060278 G3060690 (01)04562122958974(11)200127(21)G3060690 G3071074 (01)04562122958974(11)20200227(21)G3071074 G3080785 (01)04562122958974(11)201105(21)G3080785 G3090450 (01)04562122958974(11)201225(21)G3090450 G3110884 (01)04562122958974(11)210401(21)G3110884
Recalling firm:
FujiFilm Healthcare Americas Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 14, 2021

MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007

While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

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

Recall #:
93651
Lot/product code:
Model 712001 - UDI-DI 00884838028586, all serial numbers; Model 712002 - UDI-DI 00884838082373, all serial numbers; Model 712004 - UDI-DI 08436046002173, all serial numbers; Model 712006 - UDI-DI 00884838091504, serial numbers: SN20410556 and SN21410184; Model 712007 - UDI-DI)08436046002357, serial numbers: 26, 27, 19410038, 19410044, 19410046, 21410261, 21410266, 21410280, 21410288, 21410290, 21410291, 21410293, 21410294, 21410339, 21410340, 21410341, 21410342, 21410345, 22410022, 22410023, SN0410157, SN1410049, SN19410034, SN19410035, SN19410036, SN19410037, SN19410071, SN19410092, SN19410093, SN19410094, SN19410097, SN19410098, SN19410099, SN19410100, SN19410101, SN19410102, SN19410115, SN19410116, SN19410123, SN19410127, SN19410129, SN19410135, SN19410136, SN19410137, SN20410029, SN20410030, SN20410032, SN20410033, SN20410034, SN20410044, SN20410045, SN20410049, SN20410060, SN20410063, SN20410064, SN20410065, SN20410066, SN20410071, SN20410072, SN20410073, SN20410074, SN20410081, SN20410082, SN20410083, SN20410084, SN20410093, SN20410094, SN20410095, SN20410096, SN20410097, SN20410115, SN20410116, SN20410117, SN20410118, SN20410119, SN20410120, SN20410154, SN20410171, SN20410172, SN20410202, SN20410218, SN20410219, SN20410242, SN20410260, SN20410261, SN20410279, SN20410280, SN20410288, SN20410289, SN20410290, SN20410291, SN20410298, SN20410299, SN20410300, SN20410313, SN20410321, SN20410334, SN20410360, SN20410367, SN20410373, SN20410395, SN20410396, SN20410428, SN20410472, SN20410473, SN20410482, SN20410555, SN20410556, SN20410557, SN20410566, SN20410567, SN20410570, SN21410017, SN21410034, SN21410035, SN21410048, SN21410060, SN21410061, SN21410062, SN21410081, SN21410093, SN21410094, SN21410094, SN21410099, SN21410103, SN21410104, SN21410105, SN21410117, SN21410118, SN21410119, SN21410130, SN21410131, SN21410132, SN21410133, SN21410149, SN21410150, SN21410153, SN21410154, SN21410155, SN21410169, SN21410170, SN21410171, SN21410172, SN21410187, SN21410188, SN21410189, SN21410190, SN21410200, SN21410201, SN21410203, SN21410204, SN21410205, SN21410206, SN21410207, SN21410208, SN21410212, SN21410213, SN21410214, SN21410232, SNZY20410009, SNZY20410011, SNZY20410014, and SNZY204110015.
Recalling firm:
SEDECAL SA
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UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS); 39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X 18CM); 39301BCTS/CAMERA TRAY (INLINE/C-MOUNT CAMERA HEADS); 39301BS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 5MM X 35CM); 39301C1S/RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE & LT CABLE); 39301CS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPE 10MM X 31CM); 39301DS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39301HCTS/CAMERA TRAY (STERRAD, STANDARD CAMERA HEADS); 39301PHTS/CAMERA TRAY (STERRAD, PENDULUM/INLINE CAM HEADS); 39305C1S/BASKET-STYLE RIGID TELESCOPE TRAY (UDEL, 1 RIGID SCOPE 4MM X 30CM); 39305C2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39305L1S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 1 RIGID SCOPE); 39305L2S/BASKET-STYLE RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES); 39311AS/RIGID TELESCOPE TRAY (STERRAD, 4 RIGID SCOPES & LT CABLE); 39311BS/RIGID TELESCOPE TRAY (STERRAD, TWO LAP SCOPES/CABLE); 39314FS/RIGID TELESCOPE TRAY (STERRAD, FOUR LAP SCOPES/CABLE); 39401AS/FLEXIBLE ENDOSCOPE TRAY (UP TO 39CM); 39402AS/FLEXIBLE ENDOSCOPE TRAY (FIBERSCOPES); 39403AS/FLEXIBLE ENDOSCOPE TRAY (CCD VIDESCOPES); 39406AS/FLEXIBLE ENDOSCOPE TRAY (CMOS VIDEOSCOPES)

To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and maximum length of 845mm and 2) ethylene oxide is excluded as a sterilization modality.

AKALARAZCACOCTDCDEFLGAGUHIIAIDILINKSKYLAMAMDMEMIMNMOMPMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVIVTWAWIWVWY
▸Full report

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

Recall #:
88998
Lot/product code:
All lots with Instructions for Use Prior to PI-000078-10.0 (06/21)
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 15, 2021

Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE STENT GRAFT ESBF231

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

ALL 50 STATES
▸Full report

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

Recall #:
88951
Lot/product code:
Model Number/GTIN Code/Product Description: ESBF2814C103EE 00643169780446 V30609409 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609410 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609411 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609412 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609415 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609417 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609420 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609421 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30609423 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616743 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616746 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2814C103EJ 00643169440029 V30616748 STENT GRAFT ESBF2814C103EJ ENDUR IIS BIF ESBF2314C103E 00643169439993 V30618898 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618899 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2314C103E 00643169439993 V30618902 Stent Graft ESBF2314C103E Endur IIs BIF ESBF2814C103EE 00643169780446 V30618963 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618964 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618965 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618966 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618967 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618968 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618969 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618970 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618971 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618972 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618973 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618974 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618975 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618976 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618977 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618978 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618979 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618980 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618982 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618983 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618984 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618988 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30618989 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2514C103EE 00763000098858 V30619120 STENT GRAFT ESBF2514C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619159 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00763000098865 V30619161 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625915 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625916 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625917 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625918 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2314C103EE 00643169780422 V30625921 STENT GRAFT ESBF2314C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625935 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625936 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625938 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625941 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625942 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625943 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625944 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625945 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625946 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625947 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625948 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625949 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625950 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625951 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643169780446 V30625952 STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE 00643… (truncated, 12383 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 October 15, 2021

Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETBF2313C166EE STENT GRAFT ETBF2313C166EE ENDUR II BIF ETBF2513C124EE STENT GRAFT ETBF2513C124EE ENDUR II BIF ET

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

ALL 50 STATES
▸Full report

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

Recall #:
88951
Lot/product code:
Model Number/GTIN Code/Product Description: ETBF2513C145EE 00643169781047 V30584649 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593589 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593590 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593591 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593592 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593593 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593594 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE 00643169781177 V30593595 STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE 00643169780798 V30595328 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE 00643169780798 V30595331 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE 00643169780798 V30595332 STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE 00643169780934 V30595382 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595383 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595386 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595389 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595390 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE 00643169780934 V30595391 STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE 00643169780972 V30595456 STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595505 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595515 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595516 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE 00643169781047 V30595517 STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596585 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596586 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE 00643169781085 V30596587 STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596625 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596626 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596634 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596635 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596637 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596639 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596640 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596641 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE 00643169781115 V30596644 STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596645 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596646 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596648 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596649 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596650 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596651 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE 00643169781146 V30596655 STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603296 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603298 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603309 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603310 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603311 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603312 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603313 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE 00643169781078 V30603315 STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E 00643169232570 V30608080 STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE 00643169780897 V30609554 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609556 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609557 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609558 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609559 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609560 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609561 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE 00643169780897 V30609564 STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E 00613994991430 V30616355 STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616364 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616365 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E 00613994991447 V30616368 STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E 00… (truncated, 33700 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 October 15, 2021

Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube

ALL 50 STATES
▸Full report

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

Recall #:
88951
Lot/product code:
Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639
Recalling firm:
Medtronic Vascular, Inc.
View official FDA record (opens in a new tab)