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Recalls affecting Washington

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

16,836 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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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

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Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

View FDA’s announcement (opens in a new tab)
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.

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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

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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 January 17, 2022

OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

ALL 50 STATES
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FDA has not published a risk classification for this recall yet.

Recall #:
89463
Lot/product code:
HP3 010819-3104 HP3 011321-3373 HP3 031519-3128 HP3 032521-3426 HP3 051419-3157 HP3 073118-3044 HP3 090921-3516 HP3 102618-3060 HP5 011221-3374 HP5 012519-3088 HP5 032019-3123 HP5 032621-3425 HP5 051519-3158 HP5 062521-3489 HP5 070819-3186 HP5 072221-3501 HP5 083018-3036 HP5 102918-3061 HP5 122120-3368 HP7 030821-3404 HP7 032119-3124 HP7 092019-3135 HP7 103018-3062
Recalling firm:
Lacrimedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 17, 2022

Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

ALL 50 STATES
▸Full report

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

Recall #:
89463
Lot/product code:
CP3 010421-3358 CP3 031419-3125 CP3 032921-3429 CP3 042020-3284 CP3 052219-3149 CP3 061521-3482 CP3 071720-3322 CP3 080218-3045 CP3 091218-3057 CP3 122118-3093 CP4 010621-3377 CP4 022619-3094 CP4 041620-3285 CP4 041719-3126 CP4 072020-3323 CP4 092518-3058 CP5 011221-3359 CP5 033121-3430 CP5 042219-3127 CP5 042220-3286 CP5 072320-3324 CP5 082318-3010 CP5 111418-3059 HP7 103018-3062
Recalling firm:
Lacrimedics Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2022

Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.

The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.

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

Recall #:
89499
Lot/product code:
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5… (truncated, 19936 characters total — see the official FDA record for the full value)
Recalling firm:
Siemens Medical Solutions USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 19, 2022

SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMIMNMOMSMTNCNENHNJNMNVNYOHOKORPAPRSCTNTXUTVAWAWIWV
▸Full report

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

Recall #:
89673
Lot/product code:
All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x, AND The secondary modality (IntraSight IVUS) runs software version 5.x. Device Identifier (DI): 00845225012434
Recalling firm:
Volcano Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

BenchMark ULTRA and DISCOVERY ULTRA Instruments

Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVTWAWIWVWY
▸Full report

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

Recall #:
89727
Lot/product code:
Serial Numbers Less-Than-Or-Equal-To 322030
Recalling firm:
Ventana Medical Systems Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.

In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values

ALL 50 STATES
▸Full report

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

Recall #:
89645
Lot/product code:
Software versions up to and including v2.59.3. Serial Number UDI (US): Q100 +B787OLOU10/$$+7Q-100G Q121 +B787OLOU10/$$+7Q-121J Q138 +B787OLOU10/$$+7Q-138R Q145 +B787OLOU10/$$+7Q-145P Q146 +B787OLOU10/$$+7Q-146Q Q167 +B787OLOU10/$$+7Q-167T Q212 +B787OLOU10/$$+7Q-212K Q213 +B787OLOU10/$$+7Q-213L Q225 +B787OLOU10/$$+7Q-225O Q228 +B787OLOU10/$$+7Q-228R Q241 +B787OLOU10/$$+7Q-241M Q258 +B787OLOU10/$$+7Q-258U Q264 +B787OLOU10/$$+7Q-264R Q270 +B787OLOU10/$$+7Q-270O Q273 +B787OLOU10/$$+7Q-273R Q275 +B787OLOU10/$$+7Q-275T Q277 +B787OLOU10/$$+7Q-277V Q283 +B787OLOU10/$$+7Q-283S Q303 +B787OLOU10/$$+7Q-303L Q331 +B787OLOU10/$$+7Q-331M Q332 +B787OLOU10/$$+7Q-332N Q334 +B787OLOU10/$$+7Q-334P Q338 +B787OLOU10/$$+7Q-338T Q341 +B787OLOU10/$$+7Q-341N Q347 +B787OLOU10/$$+7Q-347T Q352 +B787OLOU10/$$+7Q-352P Q363 +B787OLOU10/$$+7Q-363R Q365 +B787OLOU10/$$+7Q-365T Q372 +B787OLOU10/$$+7Q-372R Q375 +B787OLOU10/$$+7Q-375U Q380 +B787OLOU10/$$+7Q-380Q Q383 +B787OLOU10/$$+7Q-383T Q384 +B787OLOU10/$$+7Q-384U Q387 +B787OLOU10/$$+7Q-387X Q391 +B787OLOU10/$$+7Q-391S Q393 +B787OLOU10/$$+7Q-393U Q394 +B787OLOU10/$$+7Q-394V Q398 +B787OLOU10/$$+7Q-398Z Q400 +B787OLOU10/$$+7Q-400J Q403 +B787OLOU10/$$+7Q-403M Q411 +B787OLOU10/$$+7Q-411L Q417 +B787OLOU10/$$+7Q-417R Q418 +B787OLOU10/$$+7Q-418S Q420 +B787OLOU10/$$+7Q-420L Q424 +B787OLOU10/$$+7Q-424P Q427 +B787OLOU10/$$+7Q-427S Q436 +B787OLOU10/$$+7Q-436S Q437 +B787OLOU10/$$+7Q-437T Q440 +B787OLOU10/$$+7Q-440N Q442 +B787OLOU10/$$+7Q-442P Q451 +B787OLOU10/$$+7Q-451P Q452 +B787OLOU10/$$+7Q-452Q Q462 +B787OLOU10/$$+7Q-462R Q463 +B787OLOU10/$$+7Q-463S Q465 +B787OLOU10/$$+7Q-465U Q467 +B787OLOU10/$$+7Q-467W Q468 +B787OLOU10/$$+7Q-468X Q469 +B787OLOU10/$$+7Q-469Y Q470 +B787OLOU10/$$+7Q-470Q Q472 +B787OLOU10/$$+7Q-472S Q489 +B787OLOU10/$$+7Q-489- Q496 +B787OLOU10/$$+7Q-496Y Q499 +B787OLOU10/$$+7Q-499. Q510 +B787OLOU10/$$+7Q-510L Q511 +B787OLOU10/$$+7Q-511M Q512 +B787OLOU10/$$+7Q-512N Q513 +B787OLOU10/$$+7Q-513O Q515 +B787OLOU10/$$+7Q-515Q Q520 +B787OLOU10/$$+7Q-520M Q524 +B787OLOU10/$$+7Q-524Q Q527 +B787OLOU10/$$+7Q-527T Q532 +B787OLOU10/$$+7Q-532P Q534 +B787OLOU10/$$+7Q-534R Q541 +B787OLOU10/$$+7Q-541P Q543 +B787OLOU10/$$+7Q-543R Q551 +B787OLOU10/$$+7Q-551Q Q552 +B787OLOU10/$$+7Q-552R Q557 +B787OLOU10/$$+7Q-557W Q559 +B787OLOU10/$$+7Q-559Y Q561 +B787OLOU10/$$+7Q-561R Q565 +B787OLOU10/$$+7Q-565V Q569 +B787OLOU10/$$+7Q-569Z Q570 +B787OLOU10/$$+7Q-570R Q571 +B787OLOU10/$$+7Q-571S Q577 +B787OLOU10/$$+7Q-577Y Q581 +B787OLOU10/$$+7Q-581T Q586 +B787OLOU10/$$+7Q-586Y Q594 +B787OLOU10/$$+7Q-594X Q614 +B787OLOU10/$$+7Q-614Q Q620 +B787OLOU10/$$+7Q-620N Q624 +B787OLOU10/$$+7Q-624R Q633 +B787OLOU10/$$+7Q-633R Q634 +B787OLOU10/$$+7Q-634S Q638 +B787OLOU10/$$+7Q-638W Q640 +B787OLOU10/$$+7Q-640P Q659 +B787OLOU10/$$+7Q-659Z Q661 +B787OLOU10/$$+7Q-661S Q664 +B787OLOU10/$$+7Q-664V Q667 +B787OLOU10/$$+7Q-667Y Q668 +B787OLOU10/$$+7Q-668Z Q669 +B787OLOU10/$$+7Q-669- Q673 +B787OLOU10/$$+7Q-673V Q676 +B787OLOU10/$$+7Q-676Y Q678 +B787OLOU10/$$+7Q-678- Q679 +B787OLOU10/$$+7Q-679. Q681 +B787OLOU10/$$+7Q-681U Q686 +B787OLOU10/$$+7Q-686Z Q687 +B787OLOU10/$$+7Q-687- Q96 +B787OLOU10/$$+7Q-096U. Serial Number UDI (OUS) Q113 +B787OLOE10/$$+7Q-1134 Q140 +B787OLOE10/$$+7Q-1404 Q142 +B787OLOE10/$$+7Q-1426 Q157 +B787OLOE10/$$+7Q-157C Q159 +B787OLOE10/$$+7Q-159E Q162 +B787OLOE10/$$+7Q-1628 Q166 +B787OLOE10/$$+7Q-166C Q170 +B787OLOE10/$$+7Q-1707 Q175 +B787OLOE10/$$+7Q-175C Q176 +B787OLOE10/$$+7Q-176D Q177 +B787OLOE10/$$+7Q-177E Q179 +B787OLOE10/$$+7Q-179G Q180 +B787OLOE10/$$+7Q-1808 Q189 +B787OLOE10/$$+7Q-189H Q191 +B787OLOE10/$$+7Q-191A Q204 +B787OLOE10/$$+7Q-2045 Q205 +B787OLOE10/$$+7Q-2056 Q206 +B787OLOE10/$$+7Q-2067 Q208 +B787OLOE10/$$+7Q-2089 Q209 +B787OLOU10/$$+7Q-209Q Q210 +B787OLOE10/$$+7Q-2102 Q216 +B787OLOE10/$$+7Q-2168 Q220 +B787OLOE10/$$+7Q-2203 Q221 +B787OLOE10/$$+7Q-2214 Q223 +B787OLOE10/$$+7Q-2236 Q224 +B787OLOE10/$$+7Q-2247 Q227 +B787OLOE10/$$+7Q-227A Q232 +B787OLOE10/$$+7Q-2326 Q233 +B787OLOE10/$$+7Q-2337 Q234 +B787OLOE10/$$+7Q-2348 Q236 +B787OLOE10/$$+7Q-236A Q237 +B787OLOE10/$$+7Q-237B Q243 +B787OLOE10/$$+7Q-2438 Q245 +B787OLOE10/$$+7Q-245A Q246 +B787OLOE10/$$+7Q-246B Q247 +B787OLOU10/$$+7Q-247S Q249 +B787OLOE10/$$+7Q-249E Q250 +B787OLOE10/$$+7Q-2506 Q251 +B787OLOE10/$$+7Q-2517 Q255 +B787OLOE10/$$+7Q-255B Q256 +B787OLOE10/$$+7Q-256C Q260 +B787OLOE10/$$+7Q-2607 Q261 +B787OLOE10/$$+7Q-2618 Q262 +B787OLOE10/$$+7Q-2629 Q263 +B787OLOE10/$$+7Q-263A Q265 +B787OLOE10/$$+7Q-265C Q267 +B787OLOE10/$$+7Q-267E Q268 +B787OLOE10/$$+7Q-268F Q271 +B787OLOE10/$$+7Q-2719 Q272 +B787OLOE10/$$+7Q-272A Q274 +B787OLOE10/$$+7Q-274C Q276 +B787OLOE10/$$+7Q-276E Q278 +B787OLOE10/$$+7Q-278G Q279 +B787OLOE10/$$+7Q-279H Q280 +B787OLOE10/$$+7Q-2809 Q281 +B787OLOE10/$$+7Q-281A Q282 +B787OLOE10/$$+7Q-282B Q284 +B787OLOE10/$$+7Q-284D Q285 +B787OLOE10/$$+7Q-285E Q286 +B787OLOE10/$$+7Q-286F Q287 +B787OLOE10/$$+7Q-287G Q288 +B787OLOE10/$$+7Q-288H Q289 +B787OLOE10/$$+7Q-289I Q290 +B787OLOE10/$$+7Q-290A Q291 +B787OLOE10/$$+7Q-291B Q293 +B787OLOE10/$$+7Q-293D Q… (truncated, 9111 characters total — see the official FDA record for the full value)
Recalling firm:
SIGHT DIAGNOSTICS LTD
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4302CSP Lot Numbers/UDI (GTIN, DI + PI): 0001412493 (01)10885403107788(17)220331(10)0001412493 0001415324 (01)10885403107788(17)220430(10)0001415324 0001416351 (01)10885403107788(17)220430(10)0001416351 0001417052 (01)10885403107788(17)220430(10)0001417052 0001417550 (01)10885403107788(17)220430(10)0001417550 0001421010 (01)10885403107788(17)220531(10)0001421010 0001422378 (01)10885403107788(17)220630(10)0001422378 0001425085 (01)10885403107788(17)220630(10)0001425085 0001426188 (01)10885403107788(17)220630(10)0001426188 0001426941 (01)10885403107788(17)220630(10)0001426941 0001428873 (01)10885403107788(17)220630(10)0001428873 0001431044 (01)10885403107788(17)220630(10)0001431044 0001433024 (01)10885403107788(17)220831(10)0001433024 0001433846 (01)10885403107788(17)220930(10)0001433846 0001437468 (01)10885403107788(17)221031(10)0001437468 0001438331 (01)10885403107788(17)221031(10)0001438331 0001439310 (01)10885403107788(17)221031(10)0001439310 0001440531 (01)10885403107788(17)221031(10)0001440531
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4301CSP Lot Numbers/UDI (GTIN, DI + PI): 0001411297 (01)10885403107771(17)220331(10)0001411297 0001412994 (01)10885403107771(17)220331(10)0001412994 0001412993 (01)10885403107771(17)220331(10)0001412993 0001413312 (01)10885403107771(17)220331(10)0001413312 0001413224 (01)10885403107771(17)220331(10)0001413224 0001415321 (01)10885403107771(17)220430(10)0001415321 0001416350 (01)10885403107771(17)220331(10)0001416350 0001416833 (01)10885403107771(17)220430(10)0001416833 0001417546 (01)10885403107771(17)220430(10)0001417546 0001418031 (01)10885403107771(17)220430(10)0001418031 0001418108 (01)10885403107771(17)220430(10)0001418108 0001418415 (01)10885403107771(17)220430(10)0001418415 0001420365 (01)10885403107771(17)220430(10)0001420365 0001421922 (01)10885403107771(17)220630(10)0001421922 0001422603 (01)10885403107771(17)220630(10)0001422603 0001422916 (01)10885403107771(17)220630(10)0001422916 0001423132 (01)10885403107771(17)220630(10)0001423132 0001424769 (01)10885403107771(17)220630(10)0001424769 0001425084 (01)10885403107771(17)220630(10)0001425084 0001426503 (01)10885403107771(17)220630(10)0001426503 0001426326 (01)10885403107771(17)220630(10)0001426326 0001427017 (01)10885403107771(17)220630(10)0001427017 0001427227 (01)10885403107771(17)220630(10)0001427227 0001427711 (01)10885403107771(17)220630(10)0001427711 0001428496 (01)10885403107771(17)220630(10)0001428496 0001429509 (01)10885403107771(17)220630(10)0001429509 0001430610 (01)10885403107771(17)220630(10)0001430610 0001430605 (01)10885403107771(17)220630(10)0001430605 0001431471 (01)10885403107771(17)220630(10)0001431471 0001432426 (01)10885403107771(17)220831(10)0001432426 0001432425 (01)10885403107771(17)220831(10)0001432425 0001433266 (01)10885403107771(17)220831(10)0001433266 0001434250 (01)10885403107771(17)220930(10)0001434250 0001437530 (01)10885403107771(17)221031(10)0001437530
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4306CSP Lot Numbers/UDI (GTIN, DI + PI): 0001410708 (01)10885403107795(17)220331(10)0001410708 0001411191 (01)10885403107795(17)220331(10)0001411191 0001412491 (01)10885403107795(17)220331(10)0001412491 0001413309 (01)10885403107795(17)220331(10)0001413309 0001416352 (01)10885403107795(17)220430(10)0001416352 0001417049 (01)10885403107795(17)220430(10)0001417049 0001420356 (01)10885403107795(17)220430(10)0001420356 0001421923 (01)10885403107795(17)220630(10)0001421923 0001422376 (01)10885403107795(17)220630(10)0001422376 0001425371 (01)10885403107795(17)220630(10)0001425371 0001426677 (01)10885403107795(17)220630(10)0001426677 0001429128 (01)10885403107795(17)220630(10)0001429128 0001432172 (01)10885403107795(17)220630(10)0001432172 0001433264 (01)10885403107795(17)220831(10)0001433264 0001433845 (01)10885403107795(17)220930(10)0001433845 0001437662 (01)10885403107795(17)221031(10)0001437662
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4304C Lot Numbers/UDI (GTIN, DI + PI): 0001414261 (01)10885403057052(17)220331(10)0001414261 0001414362 (01)10885403057052(17)220430(10)0001414362 0001415851 (01)10885403057052(17)220430(10)0001415851 0001415026 (01)10885403057052(17)220430(10)0001415026 0001421686 (01)10885403057052(17)220630(10)0001421686 0001424759 (01)10885403057052(17)220630(10)0001424759 0001426324 (01)10885403057052(17)220630(10)0001426324 0001428876 (01)10885403057052(17)220630(10)0001428876 0001432173 (01)10885403057052(17)220630(10)0001432173 0001434168 (01)10885403057052(17)220930(10)0001434168 0001438149 (01)10885403057052(17)221031(10)0001438149 0001438930 (01)10885403057052(17)221031(10)0001438930 0001441010 (01)10885403057052(17)221031(10)0001441010
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4306C Lot Numbers/UDI (GTIN, DI + PI): 0001410709 (01)10885403057069(17)220331(10)0001410709 0001411249 (01)10885403057069(17)220331(10)0001411249 0001412995 (01)10885403057069(17)220331(10)0001412995 0001414260 (01)10885403057069(17)220331(10)0001414260 0001414360 (01)10885403057069(17)220430(10)0001414360 0001415852 (01)10885403057069(17)220331(10)0001415852 0001417193 (01)10885403057069(17)220430(10)0001417193 0001415027 (01)10885403057069(17)220430(10)0001415027 0001419336 (01)10885403057069(17)220430(10)0001419336 0001422223 (01)10885403057069(17)220630(10)0001422223 0001425520 (01)10885403057069(17)220630(10)0001425520 0001426674 (01)10885403057069(17)220630(10)0001426674 0001428621 (01)10885403057069(17)220630(10)0001428621 0001429518 (01)10885403057069(17)220630(10)0001429518 0001430118 (01)10885403057069(17)220630(10)0001430118 0001433265 (01)10885403057069(17)220831(10)0001433265 0001433844 (01)10885403057069(17)220930(10)0001433844 0001434817 (01)10885403057069(17)220930(10)0001434817 0001438147 (01)10885403057069(17)221031(10)0001438147
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4306CW Lot Numbers/UDI (GTIN, DI + PI): 0001415028 (01)10885403228995(17)220430(10)0001415028 0001417842 (01)10885403228995(17)220430(10)0001417842 0001424355 (01)10885403228995(17)220630(10)0001424355 0001431413 (01)10885403228995(17)220630(10)0001431413 0001436376 (01)10885403228995(17)220930(10)0001436376
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

ALL 50 STATES
▸Full report

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

Recall #:
89616
Lot/product code:
Model Numbers: PN-0003000 UDI Codes: (01)00850001011112(11)200218; Serial Numbers: 400270 400275 400280 400818 400084 400088 400097 400098 400101 400102 400103 400476 400479 400505 400113 400122 400155 400159 400352 400353 400156 400157 400163 400164 400492 400498 400250 400265 400269 400273 400283 400816 400819 400820 400828 400234 400235 400236 400672 400685 400100 400104 400124 400481 400486 400231 400243 400244 400245 400248 400668 400686 400165 400168 400181 400359 400381 400258 400267 400271 400274 400278 400826 400225 400228 400229 400230 400281 400282 400483 400494 400495 400501 400504 400506 400507 400509 400510 400512 400262 400264 400864 400875 400876 400823 400825 400831 400835 401041 401046 401056 401059 401061 401062 401065 401066 401067 401069 401070 401071 400878 400879 400887 400896 400901 401199 401200 401201 401203 401204 400829 400830 400905 400907 400649 400651 400659 400666 400116 400121 400650 400653 400277 400708 400770 400115 400312 400330 400087 400095 400114 401129 401133 401174 401179 401232 401233 401234 401235 400889 400898 400059 400062 400063 400923 400937 400946 400950 400085 400096 400106 400107 400108 400130 400147 400154 400691 400694 400698 400529 400531 400890 400842 400851 400865 400880 400881 400917 401076 401155 401159 401162 401164 401166 401168 401169 401170 401175 401182 401188 401202 401206 401207 401212 401218 401228 400050 400071 400169 400180 400186 400192 400193 400622 400627 400628 400632 400633 400634 400635 400636 400641 400541 400568 400572 400606 400778 400782 400827 400834 400837 400838 400369 400375 400376 400377 400172 400173 400174 400175 400179 400247 400251 400252 400475 400654 400663 400403 400413 400414 400430 400433 400435 400436 400437 400441 400442 400444 400447 400554 400556 400560 400564 400566 400618 400532 400552 400558 400614 400534 400539 400548 400549 400570 400609 400598 400999 401001 400052 400066 400160 400170 400182 400184 400187 400188 400026 400028 400042 400043 400044 400046 400056 400065 400067 400132 400183 400051 400144 400148 400149 400151 400153 400205 400206 400207 400208 400480 401191 400852 400854 400855 400856 400858 400859 400862 400866 400867 400869 400318 400387 400388 400394 400409 400415 400426 400406 400416 400423 400402 400438 400440 400455 400460 400356 400367 400392 400405 400443 400045 400054 400057 400061 400064 400068 400070 400072 400073 400075 400076 400078 400079 400081 400111 400118 400119 400129 400361 400404 400407 400408 400411 400417 400418 400419 400420 400429 400434 401021 401039 401040 401044 401048 401052 401053 401054 401057 401063 400861 400868 400882 400680 400693 400752 400754 400648 400665 400690 400753 400760 400766 401241 401250 400936 400944 401105 401106 400573 400574 400575 400577 400579 400673 400768 401110 401112 401114 401117 401118 400222 400223 400224 400226 400227 400717 400722 400731 400736 400738 400263 400266 400268 400306 400313 400323 400327 400328 400331 400332 400696 400699 400702 400714 400697 400703 400706 400707 400710 400713 400701 400704 400739 400743 400431 400459 400740 400140 400439 400725 400730 400734 400931 400966 400979 400689 400692 400463 400642 400643 400647 400679 400683 400645 400657 400675 400719 400724 400726 400732 400482 400304 400540 400545 400547 400553 400561 400563 401075 401078 400105 400126 400220 400221 400254 400292 400293 400297 400298 401043 401068 401073 401074 400466 400467 401185 401189 400272 400305 400307 400309 400340 400341 400343 400344 400345 400349 400350 400351 400391 400396 400399 401104 400746 400747 400783 400996 400785 400786 400788 400795 400909 400914 400919 400935 400723 400790 400792 401222 401227 400470 400471 400472 400473 400474 400477 400478 400484 400487 400488 400489 400490 400491 400496 400497 400499 400500 400502 400515 400857 400913 400939 400973 400995 400998 401004 400764 400775 401096 401097 401080 401081 401082 401083 401084 401086 401087 401173 401193 401194 401195 401196 401197 401208 401210 401214 401216 401217 401223 401230 400284 400286 400287 400288 400289 400294 400516 400255 400256 400257 400259 400261 400290 400517 401146 401163 401176 401181 401183 401186 401187 401190 401220 401224 401229 400380 400389 400925 400947 400927 400953 400136 400138 400176 400025 400137 400152 400239 400241 400242 400150 400161 400162 400027 400134 400141 400143 400324 400325 400398 400938 400951 400863 400872 400874 400883 400884 400893 401009 401012 401029 401032 401034 400667 400787 400789 400791 400794 400926 400934 400948 400952 400957 400841 400844 400849 400860 400334 400335 400336 400337 400338 400339 400465 400058 400082 400123 400125 400177 400317 400109 400133 400139 400166 400246 400249 400253 400469 400047 400117 400178 400048 400518 400519 400873 400886 400892 400899 401088 401089 401090 401092 401093 401094 401095 401100 400360 400390 401102 401107 401115 401213 401215 401221 401225 400920 400940 400527 400530 400543 400546 400557 400565 400595 400615 400581 400583 400585 400590 400602 400605 401030 401060 401… (truncated, 19438 characters total — see the official FDA record for the full value)
Recalling firm:
Outset Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

LUMBAR PUNCTURE TRAY ADULT 18G X 3.5

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4303C Lot Numbers/UDI (GTIN, DI + PI): 0001411294 (01)10885403057021(17)220331(10)0001411294 0001414259 (01)10885403057021(17)220331(10)0001414259 0001414361 (01)10885403057021(17)220331(10)0001414361 0001415025 (01)10885403057021(17)220430(10)0001415025 0001417547 (01)10885403057021(17)220430(10)0001417547 0001422377 (01)10885403057021(17)220630(10)0001422377 0001425366 (01)10885403057021(17)220630(10)0001425366 0001426588 (01)10885403057021(17)220630(10)0001426588 0001428500 (01)10885403057021(17)220630(10)0001428500 0001431408 (01)10885403057021(17)220630(10)0001431408 0001433267 (01)10885403057021(17)220831(10)0001433267 0001433868 (01)10885403057021(17)220930(10)0001433868
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4301CDF Lot Numbers/UDI (GTIN, DI + PI): 0001433537 (01)10885403231810(17)260831(10)0001433537 0001437269 (01)10885403231810(17)260930(10)0001437269
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

LUMBAR PUNCTURE DRUG FREE TRAY 22G

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

ALL 50 STATES
▸Full report

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

Recall #:
89553
Lot/product code:
Catalog Number: 4306CWDF Lot Numbers/UDI (GTIN, DI + PI): 0001415023 (01)10885403231827(17)250731(10)0001415023 0001416353 (01)10885403231827(17)250731(10)0001416353 0001420159 (01)10885403231827(17)250731(10)0001420159 0001424771 (01)10885403231827(17)250731(10)0001424771 0001437270 (01)10885403231827(17)250731(10)0001437270
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

SAFE-T PLUS ATRAUMATIC ADULT LP TRAY

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

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

Recall #:
89553
Lot/product code:
Catalog Number: 4306CWSP Lot Numbers/UDI (GTIN, DI + PI): 0001416832 (01)10885403229008(17)220430(10)0001416832 0001417843 (01)10885403229008(17)220430(10)0001417843 0001421009 (01)10885403229008(17)220531(10)0001421009 0001424764 (01)10885403229008(17)220630(10)0001424764 0001428872 (01)10885403229008(17)220630(10)0001428872 0001436145 (01)10885403229008(17)220930(10)0001436145
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP

Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

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

Recall #:
89553
Lot/product code:
Catalog Number: 4301C Lot Numbers/UDI (GTIN, DI + PI): 0001410711 (01)10885403057038(17)220331(10)0001410711 0001411299 (01)10885403057038(17)220331(10)0001411299 0001411867 (01)10885403057038(17)220331(10)0001411867 0001414258 (01)10885403057038(17)220331(10)0001414258 0001414358 (01)10885403057038(17)220331(10)0001414358 0001414359 (01)10885403057038(17)220331(10)0001414359 0001415031 (01)10885403057038(17)220430(10)0001415031 0001415038 (01)10885403057038(17)220430(10)0001415038 0001415850 (01)10885403057038(17)220430(10)0001415850 0001415809 (01)10885403057038(17)220430(10)0001415809 0001417243 (01)10885403057038(17)220430(10)0001417243 0001417244 (01)10885403057038(17)220430(10)0001417244 0001417734 (01)10885403057038(17)220430(10)0001417734 0001418034 (01)10885403057038(17)220430(10)0001418034 0001418308 (01)10885403057038(17)220430(10)0001418308 0001418410 (01)10885403057038(17)220430(10)0001418410 0001421652 (01)10885403057038(17)220630(10)0001421652 0001421921 (01)10885403057038(17)220630(10)0001421921 0001422197 (01)10885403057038(17)220630(10)0001422197 0001422150 (01)10885403057038(17)220630(10)0001422150 0001422604 (01)10885403057038(17)220630(10)0001422604 0001425527 (01)10885403057038(17)220630(10)0001425527 0001425874 (01)10885403057038(17)220630(10)0001425874 0001426189 (01)10885403057038(17)220630(10)0001426189 0001426502 (01)10885403057038(17)220630(10)0001426502 0001427225 (01)10885403057038(17)220630(10)0001427225 0001427380 (01)10885403057038(17)220630(10)0001427380 0001429130 (01)10885403057038(17)220630(10)0001429130 0001429519 (01)10885403057038(17)220630(10)0001429519 0001430121 (01)10885403057038(17)220630(10)0001430121 0001430608 (01)10885403057038(17)220630(10)0001430608 0001431407 (01)10885403057038(17)220630(10)0001431407 0001431472 (01)10885403057038(17)220630(10)0001431472 0001432176 (01)10885403057038(17)220630(10)0001432176 0001432655 (01)10885403057038(17)220831(10)0001432655 0001433601 (01)10885403057038(17)220930(10)0001433601 0001433023 (01)10885403057038(17)220930(10)0001433023 0001434251 (01)10885403057038(17)220930(10)0001434251 0001434730 (01)10885403057038(17)220930(10)0001434730 0001436141 (01)10885403057038(17)220930(10)0001436141 0001437469 (01)10885403057038(17)221031(10)0001437469 0001437660 (01)10885403057038(17)221031(10)0001437660 0001437658 (01)10885403057038(17)221031(10)0001437658 0001437768 (01)10885403057038(17)221031(10)0001437768
Recalling firm:
Bard Peripheral Vascular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 20, 2022

PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

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

Recall #:
89534
Lot/product code:
All units SKU number ACC-06-1000
Recalling firm:
Envisiontec US Llc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 21, 2022

1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)

Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C, Left.

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

Recall #:
89413
Lot/product code:
1. Footrest, REF: 03282000, UDI: 05713464000336;  Serial Numbers: 903282000046, 903282000057, 903282000075 ,9032820000070, 903282000001, 903282000002, 903282000004 thru 903282000006, 903282000009, 903282000011, 903282000012 903282000015, 903282000016, 903282000018 thru 903282000020, 903282000023, 903282000024, 903282000025, 903282000026, 903282000028, 903282000032 thru 903282000034, 903282000036, 903282000038 thru 903282000042, 903282000044, 903282000045, 903282000047 thru 903282000051, 903282000053, 903282000055, 903282000056, 903282000058 thru 903282000061, 903282000063, 903282000064, 903282000067, 903282000068  2. Shoulder Support, REF: 03283000, UDI: 05713464000381 Serial Numbers: 903283000012, 903283000028, 903283000001 thru 903283000003, 903283000005, 903283000010, 903283000011, 903283000013 thru 903283000022, 903283000023, 903283000024, 903283000026
Recalling firm:
NRT X-RAY A/S
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 21, 2022

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

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

Recall #:
89675
Lot/product code:
Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
Recalling firm:
NeuMoDx Molecular Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 24, 2022

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

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

Recall #:
89439
Lot/product code:
1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022  2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026
Recalling firm:
Argon Medical Devices, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2022

MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860; MiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862; MiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896 The MiniMed" 630G System with SmartGuard is intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons sixteen years of age and older.

New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.

AKALARAZCACOCTDCDEFLGAHIIAIDILINKSKYLAMAMDMEMIMNMOMSMTNCNDNENHNJNMNVNYOHOKORPAPRRISCSDTNTXUTVAVIVTWAWIWVWY
▸Full report

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

Recall #:
89653
Lot/product code:
Insulin pumps distributed in the last 6 months. All devices (US) serial numbers ranging from NG2056884H TO NG2891033H and (OUS) serial numbers ranging from NG1921788H TO NG2883091
Recalling firm:
Medtronic MiniMed
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2022

HeartWare Ventricular Assist Device (HVAD) System

Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.

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

Recall #:
89559
Lot/product code:
All lots/serials for the following product model numbers: 1440, 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US, 1440, 1650, 1650, 1650CA-CLIN, 1650DE
Recalling firm:
Heartware, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled January 27, 2022

Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

Failed stability specifications for reagent kits that may result in false negative test results.

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

Recall #:
89533
Lot/product code:
Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312 Panther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331
Recalling firm:
Hologic, Inc
View official FDA record (opens in a new tab)