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Recalls affecting Wyoming

Data last updated: September 9, 2026 at 1:18 PM UTC

16,268 recalls found

Just announced

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

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

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

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled October 1, 2019

Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0185-2020
Lot/product code:
Batch Numbers: All lots within expiry.
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 1, 2019

Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

CGMP Deviations: Presence of NDMA impurity detected in product.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0175-2020
Lot/product code:
Batch Numbers: All lots within expiry.
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 3, 2019

Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager

There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.

ALL 50 STATES
Full report

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

Recall #:
84026
Lot/product code:
Serial Numbers: SPM001018A SPM001019A SPM001020A SPM001021A SPM001022A SPM001023A SPM001024A SPM001025A SPM001026A SPM001027A SPM001028A SPM001029A SPM001030A SPM001031A SPM001032A SPM001033A SPM001034A SPM001035A SPM001036A SPM001037A SPM001038A SPM001039A SPM001040A SPM001041A SPM001042A SPM001043A SPM001044A SPM001045A SPM001046A SPM001047A SPM001078A SPM001079A SPM001080A SPM001081A SPM001082A SPM001083A SPM001084A SPM001085A SPM001086A SPM001087A SPM001092A SPM001093A SPM001094A SPM001096A SPM001097A SPM001098A SPM001100A SPM001101A SPM001102A SPM001103A SPM001105A SPM001106A SPM001107A SPM001108A SPM001109A SPM001110A SPM001111A SPM001112A SPM001113A SPM001114A SPM001117A SPM001118A SPM001119A SPM001120A SPM001121A SPM001122A SPM001123A SPM001124A SPM001125A SPM001128A SPM001130A SPM001131A SPM001132A SPM001133A SPM001134A SPM001136A SPM001137A SPM001138A SPM001139A SPM001140A SPM001141A SPM001142A SPM001143A SPM001144A SPM001145A SPM001146A SPM001149A SPM001150A SPM001151A SPM001152A SPM001153A SPM001154A SPM001155A SPM001156A SPM001157A SPM001158A SPM001159A SPM001160A SPM001161A SPM001162A SPM001166A SPM001167A SPM001168A SPM001169A SPM001170A SPM001171A SPM001172A SPM001174A SPM001217A SPM001218A SPM001219A SPM001220A SPM001221A SPM001227A SPM001228A SPM001229A SPM001230A SPM001231A SPM001232A SPM001233A SPM001234A SPM001235A SPM001236A SPM001237A SPM001238A SPM001239A SPM001240A SPM001241A SPM001242A SPM001243A SPM001244A SPM001245A SPM001246A SPM001247A SPM001248A SPM001249A SPM001252A SPM001253A SPM001254A SPM001255A SPM001256A SPM001257A SPM001258A SPM001259A SPM001260A SPM001261A SPM001262A SPM001263A SPM001264A SPM001265A SPM001266A SPM001267A SPM001268A SPM001269A SPM001270A SPM001271A SPM001272A SPM001273A SPM001274A SPM001275A SPM001276A SPM001277A SPM001278A SPM001279A SPM001280A SPM001282A SPM001283A SPM001284A SPM001285A SPM001286A SPM001287A SPM001288A SPM001289A SPM001290A SPM001291A SPM001292A SPM001293A SPM001294A SPM001295A SPM001296A SPM001297A SPM001353A SPM001354A SPM001355A SPM001356A SPM001357A SPM001358A SPM001359A SPM001360A SPM001361A SPM001362A SPM001363A SPM001364A SPM001365A SPM001366A SPM001367A SPM001368A SPM001369A SPM001370A SPM001371A SPM001372A SPM001373A SPM001374A SPM001375A SPM001376A SPM001377A SPM001378A SPM001379A SPM001380A SPM001381A SPM001382A SPM001383A SPM001384A SPM001385A SPM001386A SPM001387A SPM001388A SPM001389A SPM001390A SPM001391A SPM001392A SPM001393A SPM001394A SPM001395A SPM001396A SPM001397A SPM001398A SPM001399A SPM001400A SPM001401A SPM001402A SPM001403A SPM001404A SPM001405A SPM001406A SPM001407A SPM001408A SPM001409A SPM001411A SPM001412A SPM001413A SPM001414A SPM001415A SPM001416A SPM001417A SPM001418A SPM001419A SPM001420A SPM001421A SPM001422A SPM001423A SPM001424A SPM001425A SPM001426A SPM001427A SPM001428A SPM001429A SPM001430A SPM001431A SPM001432A SPM001433A SPM001434A SPM001435A SPM001436A SPM001437A SPM001438A SPM001439A SPM001440A SPM001441A SPM001442A SPM001443A SPM001444A SPM001445A SPM001446A SPM001447A SPM001448A SPM001449A SPM001450A SPM001451A SPM001452A SPM001453A SPM001454A SPM001455A SPM001456A SPM001457A SPM001458A SPM001459A SPM001460A SPM001461A SPM001462A SPM001463A SPM001464A SPM001465A SPM001466A SPM001467A SPM001468A SPM001469A SPM001470A SPM001471A SPM001472A SPM001473A SPM001474A SPM001475A SPM001476A SPM001477A SPM001478A SPM001479A SPM001480A SPM001481A SPM001482A SPM001483A SPM001484A SPM001485A SPM001486A SPM001487A SPM001488A SPM001489A SPM001490A SPM001491A SPM001492A SPM001493A SPM001494A SPM001495A SPM001496A SPM001497A SPM001498A SPM001499A SPM001500A SPM001501A SPM001502A SPM001503A SPM001504A SPM001505A SPM001506A SPM001507A SPM001508A SPM001509A SPM001510A SPM001511A SPM001512A SPM001513A SPM001514A SPM001515A SPM001516A SPM001517A SPM001518A SPM001519A SPM001520A SPM001521A SPM001522A SPM001523A SPM001524A SPM001525A SPM001526A SPM001527A SPM001528A SPM001529A SPM001530A SPM001531A SPM001532A SPM001533A SPM001534A SPM001535A SPM001536A SPM001537A SPM001538A SPM001539A SPM001540A SPM001541A SPM001542A SPM001543A SPM001544A SPM001545A SPM001546A SPM001547A SPM001548A SPM001549A SPM001550A SPM001551A SPM001552A SPM001553A SPM001554A SPM001555A SPM001556A SPM001557A SPM001558A SPM001559A SPM001560A SPM001561A SPM001562A SPM001563A SPM001564A SPM001565A SPM001566A SPM001567A SPM001568A SPM001569A SPM001570A SPM001571A SPM001572A SPM001573A SPM001574A SPM001575A SPM001576A SPM001577A SPM001578A SPM001579A SPM001580A SPM001581A SPM001582A SPM001583A SPM001584A SPM001585A SPM001586A SPM001587A SPM001588A SPM001589A SPM001590A SPM001591A SPM001592A SPM001593A SPM001594A SPM001595A SPM001596A SPM001597A SPM001598A SPM001599A SPM001600A SPM001601A SPM001602A SPM001603A SPM001604A SPM001606A SPM001607A SPM001608A SPM001609A SPM001610A SPM001611A SPM001612A SPM001613A SPM001614A SPM001615A SPM001616A SPM001617A SPM001618A SPM001619A SPM001620A SPM001621A SPM001622A SPM001623A SPM001624A SPM001625A SPM001626A S… (truncated, 47150 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 3, 2019

Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer

There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.

ALL 50 STATES
Full report

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

Recall #:
84026
Lot/product code:
Serial Numbers: JVD000209P JVD000233P JVD000242P JVD000243P JVD000244P JVD000245P JVD000246P JVD000247P JVD000248P JVD000249P JVD000250P JVD000251P JVD000252P JVD000253P JVD000254P JVD000255P JVD000256P JVD000257P JVD000258P JVD000259P JVD000260P JVD000261P JVD000262P JVD000263P JVD000264P JVD000265P JVD000266P JVD000267P JVD000269P JVD000270P JVD000271P JVD000272P JVD000273P JVD000274P JVD000275P JVD000276P JVD000277P JVD000278P JVD000279P JVD000280P JVD000281P JVD000282P JVD000283P JVD000284P JVD000285P JVD000286P JVD000287P JVD000288P JVD000289P JVD000290P JVD000291P JVD000292P JVD000293P JVD000294P JVD000295P JVD000297P JVD000298P JVD000299P JVD000300P JVD000301P JVD000302P JVD000303P JVD000304P JVD000305P JVD000306P JVD000307P JVD000308P JVD000309P JVD000310P JVD000311P JVD000312P JVD000313P JVD000314P JVD000315P JVD000316P JVD000317P JVD000318P JVD000319P JVD000320P JVD000321P JVD000322P JVD000323P JVD000324P JVD000325P JVD000326P JVD000327P JVD000328P JVD000329P JVD000330P JVD000331P JVD000332P JVD000333P JVD000334P JVD000335P JVD000336P JVD000337P JVD000338P JVD000339P JVD000340P JVD000341P JVD000342P JVD000343P JVD000344P JVD000345P JVD000346P JVD000347P JVD000348P JVD000349P JVD000350P JVD000351P JVD000352P JVD000353P JVD000354P JVD000355P JVD000356P JVD000357P JVD000359P JVD000360P JVD000361P JVD000362P JVD000363P JVD000364P JVD000365P JVD000366P JVD000367P JVD000368P JVD000369P JVD000370P JVD000371P JVD000372P JVD000373P JVD000374P JVD000375P JVD000376P JVD000377P JVD000378P JVD000379P JVD000380P JVD000381P JVD000382P JVD000383P JVD000384P JVD000385P JVD000386P JVD000387P JVD000388P JVD000389P JVD000390P JVD000391P JVD000392P JVD000393P JVD000394P JVD000395P JVD000396P JVD000397P JVD000398P JVD000399P JVD000400P JVD000401P JVD000402P JVD000403P JVD000404P JVD000405P JVD000406P JVD000407P JVD000408P JVD000409P JVD000410P JVD000411P JVD000412P JVD000413P JVD000414P JVD000415P JVD000416P JVD000417P JVD000418P JVD000419P JVD000420P JVD000421P JVD000422P JVD000423P JVD000424P JVD000425P JVD000426P JVD000427P JVD000428P JVD000429P JVD000430P JVD000431P JVD000432P JVD000433P JVD000434P JVD000435P JVD000436P JVD000437P JVD000438P JVD000439P JVD000440P JVD000441P JVD000442P JVD000443P JVD000456P JVD000457P JVD000458P JVD000459P JVD000460P JVD000461P JVD000462P JVD000463P JVD000464P JVD000465P JVD000466P JVD000467P JVD000468P JVD000469P JVD000470P JVD000471P JVD000472P JVD000473P JVD000474P JVD000475P JVD000476P JVD000477P JVD000480P JVD000483P JVD000484P JVD000485P JVD000486P JVD000487P JVD000488P JVD000489P JVD000490P JVD000491P JVD000492P JVD000493P JVD000494P JVD000495P JVD000496P JVD000497P JVD000498P JVD000499P JVD000500P JVD000501P JVD000502P JVD000503P JVD000504P JVD000505P JVD000506P JVD000507P JVD000508P JVD000509P JVD000510P JVD000511P JVD000512P JVD000513P JVD000514P JVD000515P JVD000516P JVD000517P JVD000518P JVD000519P JVD000520P JVD000521P JVD000522P JVD000523P JVD000524P JVD000525P JVD000526P JVD000527P JVD000528P JVD000529P JVD000530P JVD000531P JVD000532P JVD001000P JVD001001P JVD001002P JVD001003P JVD001004P JVD001005P JVD001006P JVD001007P JVD001008P JVD001009P JVD001010P JVD001011P JVD001012P JVD001013P JVD001014P JVD001015P JVD001016P JVD001017P JVD001018P JVD001019P JVD001020P JVD001021P JVD001022P JVD001023P JVD001024P JVD001025P JVD001026P JVD001027P JVD001028P JVD001029P JVD001030P JVD001031P JVD001032P JVD001033P JVD001034P JVD001035P JVD001036P JVD001037P JVD001038P JVD001039P JVD001040P JVD001041P JVD001042P JVD001043P JVD001044P JVD001045P JVD001046P JVD001047P JVD001048P JVD001049P JVD001050P JVD001051P JVD001052P JVD001053P JVD001054P JVD001055P JVD001056P JVD001057P JVD001058P JVD001059P JVD001060P JVD001061P JVD001062P JVD001063P JVD001064P JVD001065P JVD001066P JVD001067P JVD001068P JVD001069P JVD001070P JVD001071P JVD001072P JVD001073P JVD001074P JVD001075P JVD001076P JVD001077P JVD001078P JVD001079P JVD001080P JVD001081P JVD001082P JVD001083P JVD001084P JVD001085P JVD001086P JVD001087P JVD001088P JVD001089P JVD001090P JVD001091P JVD001092P JVD001093P JVD001094P JVD001095P JVD001096P JVD001097P JVD001098P JVD001099P JVD001100P JVD001101P JVD001102P JVD001103P JVD001104P JVD001105P JVD001106P JVD001107P JVD001108P JVD001109P JVD001110P JVD001111P JVD001112P JVD001113P JVD001114P JVD001115P JVD001116P JVD001117P JVD001118P JVD001119P JVD001120P JVD001121P JVD001122P JVD001123P JVD001124P JVD001125P JVD001126P JVD001127P JVD001128P JVD001129P JVD001130P JVD001131P JVD001132P JVD001133P JVD001134P JVD001135P JVD001136P JVD001137P JVD001138P JVD001139P JVD001140P JVD001141P JVD001142P JVD001143P JVD001144P JVD001145P JVD001146P JVD001147P JVD001148P JVD001149P JVD001150P JVD001151P JVD001152P JVD001153P JVD001154P JVD001155P JVD001156P JVD001157P JVD001158P JVD001159P JVD001160P JVD001161P JVD001162P JVD001163P JVD001164P JVD001165P JVD001166P JVD001167P JVD001168P JVD001169P JVD001170P JVD001171P JVD001172P JVD001173P JVD001174P JVD001175P JVD001176P JVD001177P JVD001178P J… (truncated, 89951 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 3, 2019

Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer

There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.

ALL 50 STATES
Full report

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

Recall #:
84026
Lot/product code:
Serial Numbers:  PKK051331R PKK200187R PKK209956R PKK207572R PKK209265R PKK016592R PKK202460R PKK019811R PKK209256R PKK007753R PKK015981R PKK016604R PKK017955R PKK018301R PKK019555R PKK019776R PKK051452R PKK052792R PKK204491R PKK204504R PKK204551R PKK204575R PKK204595R PKK204640R PKK204740R PKK203409R PKK006360R PKK202461R PKK018408R PKK019864R PKK204483R PKK016046R PKK016047R PKK019820R PKK020201R PKK010563R PKK209937R PKK209928R PKK050581R PKK209305R PKK211241R PKK209294R PKK201567R PKK206687R PKK211282R PKK208961R PKK209373R PKK202996R PKK210858R PKK202566R PKK211233R PKK205628R PKK209203R PKK211710R PKK100124R PKK211042R PKK210807R PKK200224R PKK208864R PKK209197R PKK208958R PKK209332R PKK211720R PKK016352R PKK019371R PKK211286R PKK202507R PKK205997R PKK205974R PKK202465R PKK017835R PKK018895R PKK201637R PKK201640R PKK201643R PKK201645R PKK202394R PKK202397R PKK202411R PKK202428R PKK202441R PKK202444R PKK202451R PKK202454R PKK202459R PKK202463R PKK202464R PKK202466R PKK202489R PKK202494R PKK202521R PKK202550R PKK202552R PKK202553R PKK202557R PKK202558R PKK202561R PKK202563R PKK202564R PKK202565R PKK202567R PKK204964R PKK204973R PKK204974R PKK204983R PKK204985R PKK205962R PKK205968R PKK205970R PKK205977R PKK205979R PKK205982R PKK205986R PKK205989R PKK205994R PKK205998R PKK205999R PKK206000R PKK207397R PKK207399R PKK207576R PKK207588R PKK207601R PKK207603R PKK207604R PKK207606R PKK207607R PKK207615R PKK207621R PKK207622R PKK207623R PKK207628R PKK207649R PKK207650R PKK208500R PKK208503R PKK208508R PKK208510R PKK211023R PKK211064R PKK211072R PKK211084R PKK211100R PKK211227R PKK211228R PKK211229R PKK211235R PKK211238R PKK211239R PKK211284R PKK211289R PKK211294R PKK211339R PKK211342R PKK203579R PKK107297R PKK108724R PKK108726R PKK108729R PKK109569R PKK201389R PKK201402R PKK051032R PKK051031R PKK010204R PKK106139R PKK106149R PKK106153R PKK106161R PKK106164R PKK106212R PKK106221R PKK106224R PKK106228R PKK054839R PKK054899R PKK054903R PKK006109R PKK011161R PKK011162R PKK012402R PKK012404R PKK020167R PKK052616R PKK052619R PKK208773R PKK206171R PKK108840R PKK205827R PKK018974R PKK054297R PKK052590R PKK055474R PKK019344R PKK208281R PKK020200R PKK056378R PKK107503R PKK106539R PKK005940R PKK201926R PKK202805R PKK205627R PKK003769R PKK016555R PKK004307R PKK001417R PKK006119R PKK005232R PKK004040R PKK013386R PKK019411R PKK052102R PKK018098R PKK101253R PKK205556R PKK102674R PKK006689R PKK200245R PKK106865R PKK211492R PKK017878R PKK010764R PKK211518R PKK211521R PKK057197R PKK011242R PKK200949R PKK051450R PKK018218R PKK057195R PKK201686R PKK020573R PKK014310R PKK054238R PKK209424R PKK208646R PKK208224R PKK020366R PKK207934R PKK053799R PKK108035R PKK204464R PKK051548R PKK203435R PKK014418R PKK102204R PKK050960R PKK108305R PKK001172R PKK102818R PKK205393R PKK013868R PKK053717R PKK053233R PKK002545R PKK202693R PKK002871R PKK106723R PKK055305R PKK108322R PKK102503R PKK202024R PKK003498R PKK004347R PKK015584R PKK105180R PKK003235R PKK014949R PKK018886R PKK019330R PKK104774R PKK014465R PKK054834R PKK055373R PKK101011R PKK106795R PKK205887R PKK205332R PKK002384R PKK015619R PKK055620R PKK003926R PKK006407R PKK007261R PKK014428R PKK017571R PKK019868R PKK050318R PKK107143R PKK006589R PKK018884R PKK103154R PKK107158R PKK204136R PKK015641R PKK104118R PKK001847R PKK002178R PKK053006R PKK017686R PKK211216R PKK201780R PKK015586R PKK101918R PKK006674R PKK013504R PKK052353R PKK100694R PKK102490R PKK106404R PKK003165R PKK007298R PKK052052R PKK105856R PKK100708R PKK052050R PKK102715R PKK006557R PKK101957R PKK002398R PKK004434R PKK006460R PKK101141R PKK003318R PKK017784R PKK107927R PKK209592R PKK052937R PKK103113R PKK103401R PKK107979R PKK102706R PKK103417R PKK051039R PKK108929R PKK002518R PKK018602R PKK014370R PKK050450R PKK018051R PKK018954R PKK006683R PKK015308R PKK206137R PKK017096R PKK201696R PKK013110R PKK053602R PKK103395R PKK104573R PKK106395R PKK106663R PKK107105R PKK108835R PKK019743R PKK002029R PKK006880R PKK007419R PKK052069R PKK012323R PKK051108R PKK207988R PKK053982R PKK055228R PKK201744R PKK002557R PKK208342R PKK013078R PKK014144R PKK014900R PKK055981R PKK103121R PKK001953R PKK005823R PKK007818R PKK005994R PKK015611R PKK051055R PKK056120R PKK056431R PKK014363R PKK014324R PKK017674R PKK019498R PKK003199R PKK005355R PKK007162R PKK103381R PKK013092R PKK056024R PKK056434R PKK103151R PKK104749R PKK106810R PKK107817R PKK010011R PKK206429R PKK004752R PKK003279R PKK011923R PKK208647R PKK004440R PKK208616R PKK202512R PKK208696R PKK002498R PKK208692R PKK101219R PKK006587R PKK018978R PKK055097R PKK207723R PKK106912R PKK203509R PKK201788R PKK006737R PKK206152R PKK011005R PKK015511R PKK012410R PKK015570R PKK019464R PKK013598R PKK001597R PKK007512R PKK018480R PKK100995R PKK003991R PKK004471R PKK105584R PKK001580R PKK011440R PKK053484R PKK002364R PKK010024R PKK050689R PKK006639R PKK014435R PKK011200R PKK205410R PKK055049R PKK102825R PKK104021R PKK014983R PKK017725R PKK050719R PKK005068R PKK107473R PKK017915R PKK104060R PKK208481R PKK107727R … (truncated, 501142 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified users in

The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.

ALL 50 STATES
Full report

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

Recall #:
85526
Lot/product code:
All lots
Recalling firm:
Ventana Medical Systems Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 113081; All Lot numbers; GTIN: 07332414105266
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 114870; All Lot numbers; GTIN: 07332414115395. Device not distributed in the US.
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 6023014700; All Lot numbers; GTIN: 07332414073718.
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

ALL 50 STATES
Full report

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

Recall #:
84032
Lot/product code:
Codes: 73J1600836 73C1700518 73D1800018 73H1800233 73A1900664 73J1600837 73C1700842 73D1800019 73H1800234 73B1900436 73K1600114 73D1700008 73D1800020 73H1800235 73B1900437 73K1600115 73D1700009 73D1800558 73H1800236 73B1900438 73K1600290 73D1700010 73D1800559 73H1800240  73K1600515 73D1700068 73D1800560 73H1800496  73K1600814 73D1700069 73D1800561 73H1800497  73L1600097 73D1700313 73D1800562 73H1800498  73L1600098 73D1700314 73D1800563 73H1800499  73L1600099 73D1700315 73D1800564 73H1800500  73L1600100 73D1700496 73D1800565 73H1800501  73L1600101 73D1700497 73E1800526 73H1800502  73L1600274 73D1700574 73E1800527 73H1800639  73L1600275 73D1700575 73E1800528 73H1800640  73L1600276 73F1700209 73E1800529 73H1800641  73L1600277 73F1700210 73E1800530 73H1800642  73L1600278 73G1700345 73F1800263 73H1800643  73L1600279 73G1700346 73F1800264 73H1800820  73L1600280 73G1700347 73F1800265 73J1800298  73L1600540 73G1700720 73F1800266 73J1800299  73L1600792 73G1700721 73F1800267 73J1800300  73L1600793 73H1700095 73F1800268 73J1800301  73L1600794 73H1700096 73F1800269 73J1800302  73L1600795 73H1700097 73F1800270 73J1800303  73L1600796 73H1700098 73F1800486 73J1800304  73L1600797 73B1800105 73F1800487 73J1800305  73L1600798 73B1800106 73F1800759 73J1800306  73M1600217 73B1800188 73F1800760 73J1800718  73M1600218 73B1800189 73F1800761 73J1800719  73M1600219 73B1800190 73G1800089 73J1800720  73M1600220 73B1800192 73G1800520 73K1800055  73M1600281 73B1800216 73G1800521 73K1800057  73M1600282 73B1800217 73G1800522 73K1800058  73A1700205 73C1800125 73G1800525 73K1800691  73A1700206 73C1800126 73G1800726 73K1800694  73A1700207 73C1800127 73G1800727 73K1800700  73A1700348 73C1800128 73G1800728 73K1800701  73A1700349 73C1800129 73G1800729 73K1800702  73B1700226 73C1800130 73G1800730 73K1800703  73B1700276 73C1800131 73G1800731 73M1800021  73B1700486 73C1800132 73G1800877 73M1800022  73B1700487 73D1800013 73G1800878 73M1800023  73C1700335 73D1800014 73H1800138 73M1800024  73C1700360 73D1800015 73H1800139 73M1800025  73C1700361 73D1800016 73H1800231 73A1900662  73C1700362 73D1800017 73H1800232 73A1900663
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 107493; All Lot numbers; GTIN: 07332414073718
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

Prismaflex Control Unit, software versions below 7.21

Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

ALL 50 STATES
Full report

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

Recall #:
83852
Lot/product code:
Product Code: 115269 (GTIN: 07332414117702), 955542 GTIN: 07332414124236); All Lot numbers
Recalling firm:
Baxter Healthcare Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 4, 2019

WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, or the jaws becoming locked in a partially closed position (jammed).

ALL 50 STATES
Full report

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

Recall #:
84032
Lot/product code:
Codes: 73J1600836 73C1700518 73D1800018 73H1800233 73A1900664 73J1600837 73C1700842 73D1800019 73H1800234 73B1900436 73K1600114 73D1700008 73D1800020 73H1800235 73B1900437 73K1600115 73D1700009 73D1800558 73H1800236 73B1900438 73K1600290 73D1700010 73D1800559 73H1800240  73K1600515 73D1700068 73D1800560 73H1800496  73K1600814 73D1700069 73D1800561 73H1800497  73L1600097 73D1700313 73D1800562 73H1800498  73L1600098 73D1700314 73D1800563 73H1800499  73L1600099 73D1700315 73D1800564 73H1800500  73L1600100 73D1700496 73D1800565 73H1800501  73L1600101 73D1700497 73E1800526 73H1800502  73L1600274 73D1700574 73E1800527 73H1800639  73L1600275 73D1700575 73E1800528 73H1800640  73L1600276 73F1700209 73E1800529 73H1800641  73L1600277 73F1700210 73E1800530 73H1800642  73L1600278 73G1700345 73F1800263 73H1800643  73L1600279 73G1700346 73F1800264 73H1800820  73L1600280 73G1700347 73F1800265 73J1800298  73L1600540 73G1700720 73F1800266 73J1800299  73L1600792 73G1700721 73F1800267 73J1800300  73L1600793 73H1700095 73F1800268 73J1800301  73L1600794 73H1700096 73F1800269 73J1800302  73L1600795 73H1700097 73F1800270 73J1800303  73L1600796 73H1700098 73F1800486 73J1800304  73L1600797 73B1800105 73F1800487 73J1800305  73L1600798 73B1800106 73F1800759 73J1800306  73M1600217 73B1800188 73F1800760 73J1800718  73M1600218 73B1800189 73F1800761 73J1800719  73M1600219 73B1800190 73G1800089 73J1800720  73M1600220 73B1800192 73G1800520 73K1800055  73M1600281 73B1800216 73G1800521 73K1800057  73M1600282 73B1800217 73G1800522 73K1800058  73A1700205 73C1800125 73G1800525 73K1800691  73A1700206 73C1800126 73G1800726 73K1800694  73A1700207 73C1800127 73G1800727 73K1800700  73A1700348 73C1800128 73G1800728 73K1800701  73A1700349 73C1800129 73G1800729 73K1800702  73B1700226 73C1800130 73G1800730 73K1800703  73B1700276 73C1800131 73G1800731 73M1800021  73B1700486 73C1800132 73G1800877 73M1800022  73B1700487 73D1800013 73G1800878 73M1800023  73C1700335 73D1800014 73H1800138 73M1800024  73C1700360 73D1800015 73H1800139 73M1800025  73C1700361 73D1800016 73H1800231 73A1900662  73C1700362 73D1800017 73H1800232 73A1900663  73F1700597 73M1700020 73C1800265 73E1800326 73F1800733 73F1700598 73M1700074 73C1800266 73E1800327 73F1800734 73F1700599 73M1700112 73C1800267 73E1800328 73G1800171 73G1700468 73M1700113 73C1800268 73E1800329 73G1800172 73G1700469 73M1700114 73C1800515 73E1800330 73G1800264 73G1700472 73M1700115 73C1800516 73E1800331 73G1800265 73G1700473 73M1700116 73C1800517 73E1800332 73G1800266 73G1700554 73M1700286 73C1800578 73E1800333 73G1800267 73G1700555 73M1700287 73C1800627 73E1800334 73G1800289 73G1700556 73M1700288 73C1800628 73E1800764 73G1800290 73G1700557 73M1700289 73C1800629 73E1800765 73G1800291 73G1700558 73M1700290 73C1800630 73E1800766 73G1800292 73H1700821 73M1700291 73C1800631 73E1800767 73G1800293 73H1700835 73A1800244 73C1800632 73E1800768 73G1800294 73H1700836 73A1800589 73C1800633 73E1800769 73G1800295 73K1700553 73A1800596 73D1800209 73E1800770 73G1800296 73K1700567 73A1800597 73D1800210 73E1800771 73G1800868 73K1700568 73A1800598 73D1800211 73E1800772 73G1800872 73K1700570 73A1800605 73D1800212 73F1800091 73G1800873 73K1700571 73A1800742 73D1800213 73F1800092 73G1800874 73L1700001 73A1800823 73D1800372 73F1800093 73G1800875 73L1700002 73A1800824 73D1800373 73F1800094 73G1800876 73L1700004 73A1800825 73D1800374 73F1800095 73H1800071 73L1700007 73A1800827 73D1800375 73F1800096 73H1800140 73L1700023 73A1800828 73D1800376 73F1800097 73H1800141 73L1700107 73B1800286 73D1800377 73F1800098 73H1800142 73L1700108 73B1800287 73D1800668 73F1800099 73H1800143 73L1700189 73B1800288 73E1800023 73F1800407 73H1800144 73L1700190 73B1800289 73E1800024 73F1800408 73H1800145 73L1700277 73B1800291 73E1800025 73F1800409 73H1800228 73L1700278 73B1800292 73E1800026 73F1800410 73H1800229 73L1700280 73B1800468 73E1800027 73F1800411 73H1800638 73L1700281 73B1800469 73E1800028 73F1800412 73H1800829 73L1700282 73B1800525 73E1800033 73F1800586 73H1800830 73L1700351 73B1800526 73E1800034 73F1800587 73J1800030 73L1700462 73B1800527 73E1800165 73F1800588 73J1800031 73L1700463 73B1800528 73E1800166 73F1800589 73J1800032 73L1700464 73B1800529 73E1800167 73F1800590 73J1800033 73L1700465 73B1800676 73E1800198 73F1800591 73J1800034 73L1700466 73B1800677 73E1800199 73F1800675 73J1800035 73L1700467 73B1800678 73E1800200 73F1800727 73J1800036 73L1700587 73B1800679 73E1800201 73F1800728 73J1800385 73L1700588 73B1800680 73E1800202 73F1800729 73J1800386 73L1700589 73B1800681 73E1800203 73F1800730 73J1800387 73L1700590 73C1800263 73E1800204 73F1800731 73J1800388 73L1700591 73C1800264 73E1800325 73F1800732 73J1800480 73J1800481 73L1800353 73A1900048 73B1900227  73J1800482 73L1800354 73A1900049 73B1900228  73J1800483 73L1800355 73A1900233 73B1900229  73J1800484 73L1800356 73A1900234 73B1900230  73J1800485 73L1800357 73A1900235 73B1900231  73J1800486 73L1800358 73A1900236 73B1900429  73J1800487 73L1800359 73A1900237 73B1900430  73J1800488 73L1800541 73A1900238 73B19… (truncated, 6715 characters total — see the official FDA record for the full value)
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 7, 2019

Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)

Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.

Full report

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

Recall #:
86941
Lot/product code:
Serial # range: HF-4258BKHA0001 to HF4258RDHK0352 (Purchased before April 4th,2019)
Recalling firm:
Nova Ortho-Med Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2019

Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

ALL 50 STATES
Full report

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

Recall #:
84054
Lot/product code:
All
Recalling firm:
Teleflex Medical
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UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2019

Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

ALL 50 STATES
Full report

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

Recall #:
84054
Lot/product code:
All
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 8, 2019

Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intraosseous Vascular Access System provides intraosseous access in the proximal humerus, proximal tibia, and distal tibia of adult and pediatric patients, and the distal femur in pediatric patients when vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The safety cap attached to needles within the needle sets may become dislodged exposing the needle and potentially causing the needle to protrude through the packaging. If this issue is not detected, the immediate risk of exposure to the affected devices is needle stick injury to the clinician or health care professional. In addition, a puncture of the packaging may compromise the sterility of the needle.

ALL 50 STATES
Full report

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

Recall #:
84054
Lot/product code:
All
Recalling firm:
Teleflex Medical
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 9, 2019

Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301

The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.

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Full report

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

Recall #:
84028
Lot/product code:
All systems using Software version VG2.3.1 and lower
Recalling firm:
Draegar Medical Systems, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled October 11, 2019

Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

ALL 50 STATES
Full report

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

Recall #:
85551
Lot/product code:
Lot/Batch Numbers: 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219
Recalling firm:
TELEFLEX MEDICAL INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 11, 2019

Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

ALL 50 STATES
Full report

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

Recall #:
85551
Lot/product code:
Lot/Batch Numbers: 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, 74L1800502
Recalling firm:
TELEFLEX MEDICAL INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

MicroScan WalkAway-40 plus Instrument REF B1018-283

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

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Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-283 UDI-DI Code: 1509959065866 Serial Numbers: 34010003 34010004 34010005 34010006 34010007 34010008 34010009 34010010 34010011 34010012 34010013 34010014 34010015 34010016 34010017 34010018 34010019 34010020 34010021 34010022 34010023 34010024
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

MicroScan WalkAway-96 plus Instrument REF B1018-284

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

ALL 50 STATES
Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-284 UDI-DI Code: 15099590658687 Serial Numbers: 39610007 39610008 39610009 39610010 39610011 39610012 39610013
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

DxM 1040 MicroScan WalkAway Instrument REF B1018-440

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

ALL 50 STATES
Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-440 UDI-DI Code: 15099590690885 Serial Numbers: 44010026 44010027 44010028 44010029 44010030 44010031 44010032 44010033 44010035 44010036 44010037 44010038 44010040 44010041 44010042 44010043 44010044 44010045 44010046 44010047 44010048 44010049 44010050 44010051 44010052 44010053 44010054 44010055 44010056 44010057 44010058 44010059 44010060 44010061 44010063 44010064 44010065 44010066 44010067 44010068
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

DxM 1096 MicroScan WalkAway Instrument REF B1018-496

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

ALL 50 STATES
Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-496 UDI-DI Code: 15099590690892 Serial Numbers: 49610039 49610040 49610041 49610042 49610043 49610044 49610045 49610046 49610047 49610048 49610050 49610051 49610052 49610053 49610054 49610055 49610056 49610057 49610058 49610059 49610060 49610062 49610063 49610064 49610065 49610066 49610067 49610068 49610069 49610070 49610071 49610072 49610073 49610074 49610075 49610078 49610079 49610080 49610081 49610082 49610083 49610084 49610085 49610086 49610087 49610088 49610089 49610090 49610091
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 21, 2019

MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R

WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

ALL 50 STATES
Full report

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

Recall #:
90087
Lot/product code:
Catalog Number: B1018-340R UDI-DI Code: 15099590684112 Serial Numbers: 34020035 34020224 34030054
Recalling firm:
Beckman Coulter Inc.
View official FDA record (opens in a new tab)