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Recalls affecting Minnesota

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

16,909 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
UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2019

Karl Storz, Model # 11161C2, Flexible Neuroscope

During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

Full report

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

Recall #:
84896
Lot/product code:
All Lots
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 27, 2019

Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.

Full report

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

Recall #:
84896
Lot/product code:
All Lots
Recalling firm:
Karl Storz Endoscopy
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2019

ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

ALL 50 STATES
Full report

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

Recall #:
83813
Lot/product code:
1. Product Code: 3F, No UDI Number, Serial Numbers: M13F1043G, B23F1531G, B23F1532G, B23F2216G, A23F1290G, B23F1324G, M13F1152G, M13F1153G, M13F1154G, M13F1155G, M13F1164G, M13F1165G, M13F1166G, M13F1168G, M13F1169G, L13F0687G, D23F1925G, D23F1968G, E23F2074G, E23F2075G, B23F1402G, M13F1059G, M13F1173G, M13F1109G, C23F1815G, A23F1260G, J13F0272G, C23F1607G, D23F1981G, M13F0968G, L13F0683G, L13F0576G, J13F0274G, B23F1302G, K13F0437G, C23F1793G, D23F1943G, M13F1094G, B23F1495G, K13F0481G, L13F0571G, B23F1304G, C23F1808G, D23F1899G, M13F1151G, J13F0098G, J13F0099G, J13F0100G, C23F1594G, M13F1099G, B23F1439G, J13F0229G, L13F0600G, K13F0499G, K13F0500G, K13F0501G, L13F0623G, L13F0624G, L13F0625G, B23F13886, B23F1388G, B23F1390G, D23F1851G, D23F1861G, J13F0369G, M13F1075G, M13F1084G, M13F0891G, M13F0892G, A23F1229G, E23F2036G, L13F0776G, A23F1258G, B23F1315G, B23F1496G, B23F1501G, B23F1502G, B23F1506G, B23F1508G, C23F1784G, F13F0006G, J13F0006G, L13F0864G, L13F0865G, L13F0866G, L13F0668G, J13F0291G, J13F0292G, J13F0300G, M13F0950G, M13F1150G, B23F1313G, M13F0995G, M13F1044G, C23F1699G, J13F0293G, J13F0294G, J13F0295G, J13F0374G, J13F0375G, J13F0378G, J13F0379G, L13F0721G, L13F0729G, L13F0767G, L13F0768G, L13F0769G, M13F1062G, M13F1063G, E23F2068G, M13F1069G, D23F1852G, K13F0415G, K13F0426G, B23F1454G, D23F1971G, D23F1987G, K13F0411G, K13F0387G, L13F0755G, M13F1141G, M13F1142G, J13F0333G, J13F0203G, D23F1936G, M13F0991G, B23F1452G, B23F1509G, D23F1980G, D23F1982G, E23F2064G, J13F0308G, M13F1032G, M13F1034G, M13F1046G, M13F1047G, L13F0669G, A23F1266G, A23F1267G, A23F1297G, C23F1589G, B23F1357G, B23F1358G, M13F1074G, D23F1859G, D23F1933G, F23F2081G, F23F2090G, F23F2091G, F23F2092G, F23F2111G, A23F1263G, B23F1362G, C23F1690G, D23F1877G, D23F1888G, D23F1997G, D23F2014G, J13F0250G, J13F0252G, J13F0255G, K13F0462G, K13F0464G, K13F0518G, K13F0533G, L13F0691G, L13F0692G, L13F0741G, M13F0917G, M13F0927G, M13F0939G, M13F0972G, M13F0973G, M13F0993G, M13F0994G, M13F1033G, M13F1045G, M13F1048G, M13F1051G, M13F1070G, M13F1106G, M13F1107G, M13F1108G, M13F1114G, M13F1146G, D23F1867G, L13F0631G, C23F1809G, D23F1835G, L13F0607G, C23F1777G, J13F0222G, J13F0219G, C23F1800G, C23F1801G, C23F1802G, J13F0072G, B23F1346G, B23F1347G, B23F1348G, D23F1853G, M13F1073G, D23F1854G, D23F1855G, D23F1856G, B23F1516G, B23F1526G, B23F1527G, C23F1649G, C23F1779G, K13F0566G, J13F0245G, M13F0940G, D23F1958G, E23F2079G, E23F2072G, K13F0431G, K13F0432G, K13F0435G, K13F0563G, K13F0564G, K13F0565G, A23F1250G, A23F1257G, B23F1316G, J13F0313G, J13F0314G, J13F0315G, A23F1246G, A23F1249G, C23F1728G, C23F1757G, D23F1994G, M13F1040G, L13F0616G, L13F0861G, J13F0273G, A23F1282G, K13F0475G, C23F1767G, C23F1769G, C23F1770G, C23F1772G, D23F1846G, J13F0367G, J13F0368G, D23F1946G, B23F1510G, B23F1512G, B23F1513G, B23F1517G, B23F1521G, B23F1529G, B23F1530G, B23F1534G, B23F1539G, B23F1544G, C23F1725G, C23F1726G, K13F0524G, L13F0724G, L13F0730G, A23F1196G, A23F1198G, B23F1473G, L13F0809G, L13F0810G, L13F0811G, L13F0813G, L13F0814G, C23F1817G, C23F1818G, D23F1839G, M13F0949G, J13F0048G, J13F0189G, J13F0280G, J13F0281G, J13F0348G, M13F1049G, M13F1050G, C23F1723G, D23F1967G, K13F0402G, K13F0406G, K13F0407G, M13F0969G, M13F0975G, M13F0941G, M13F0948G, J13F0324G, B23F1518G, B23F1538G, M13F1052G, M13F1053G, M13F1066G, M13F1067G, K13F0506G, E23F2030G, B23F1423G, B23F1498G, C23F1750G, C23F1756G, D23F1864G, D23F1879G, D23F1960G, D23F2614G, M13F1130G, M13F1131G, D23F2001G, E23F2069G, M13F0976G, M13F1054G, M13F1136G, M13F1137G, M13F1148G, M13F1149G, A23F1286G, M13F1030G, M13F1031G, B23F1309G, J13F0323G, J13F0271G, L13F0614G, L13F0615G, L13F0663G, M13F0945G, M13F0946G, A23F1294G, B23F1528G, M13F1098G, C23F1786G, A23F1224G, A23F1240G, A23F1269G, B23F1329G, B23F1546G, B23F1547G, D23F1841G, D23F1845G, D23F1848G, D23F1947G, D23F1953G, D23F1954G, D23F1956G, D23F2013G, D23F2016G, D23F2017G, J13F0242G, J43F0481G, L13F0612G, M13F1122G, C23F1585G, L13F0637G, A23F1291G, A23F1293G, C23F1791G, L13F0713G, L13F0714G, L13F0685G, B23F1363G, C23F1789G, C23F1790G, C23F1813G, D23F1926G, D23F1966G, D23F1969G, D23F2000G, D23F2018G, D23F2019G, J13F0026G, J13F0247G, J13F0316G, J13F0317G, J13F0382G, J13F0383G, J13F0384G, K13F0390G, K13F0463G, L13F0753G, L13F0840G, L13F0841G, L13F0842G, M13F1056G, M13F1160G, B23F1372G, D23F1908G, D23F2012G, E23F2031G, L13F0594G, L13F0606G, M13F1110G, M13F1111G, M13F1112G, M13F1113G, M13F1115G, M13F1116G, M13F1117G, M13F1118G, M13F1119G, K13F0465G, K13F0482G, K13F0483G, L13F0596G, L13F0602G, D23F1998G, L13F0772G, M13F1089G, M13F1143G, M13F0928G, F23F2080G, C23F1785G, C23F1795G, D23F1913G, A23F1247G, A23F1248G, A23F1251G, A23F1252G, A23F1253G, B23F1305G, B23F1306G, B23F1314G, B23F1317G, B23F1318G, B23F1320G, B23F1376G, B23F1407G, B23F1408G, B23F1409G, B23F1410G, B23F1457G, B23F1458G, B23F1459G, B23F1460G, B23F1461G, B23F1462G, B23F1463G, B23F1464G, B23F1472G, B23F1474G, B23F1481G, B23F1482G, B23F1491G, B23F1492G, B23F1493G, B23F1494G, C23F1695G, C23F1696G, C23F1697G, C23F1698G… (truncated, 535363 characters total — see the official FDA record for the full value)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled August 30, 2019

SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: 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. The device is intended for adult and pediatric patients.

Problem with packaging sealing process which affects sterility.

ALL 50 STATES
Full report

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

Recall #:
83714
Lot/product code:
Lot Numbers 1240 through 1313. Item numbers:   1. 321151-30C;   2. 331151-30C;   3. 321151-31C;   4. 341151-30C;   5. 321151-31A;   6. 341151-31A;   7. 341151-31B;   8. 331151-31B
Recalling firm:
Pajunk GmbH
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2019

Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, EUP2520X, EUP2525X, EUP2530X, EUP27506X, EUP27510X, EUP27512X, EUP27515X, EUP27520X, EUP27525X, EUP3006X, EUP3010X, EUP3012X, EUP3015X, EUP3020X, EUP3025X, EUP3030X, EUP32506X, EUP32510X, EUP32512X, EUP32515X, EUP32520X, EUP32525X, EUP3506X, EUP3510X, EUP3512X, EUP3515X, EUP3520X, EUP3525X, EUP3530X, EUP37506X, EUP37510X, EUP37512X, EUP37515X, EUP37520X, EUP37525X, EUP4006X, EUP4010X, EUP4012X, EUP4015X, EUP4020X, EUP4025X, EUP4030X

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

ALL 50 STATES
Full report

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

Recall #:
83797
Lot/product code:
Product Number / CFN GTIN Lot EUP1506X 00643169559813 217238068 EUP1506X 00643169618695 217291131 EUP1506X 00643169559813 217354645 EUP1506X 00643169979475 217473721 EUP1506X 00643169618695 217473914 EUP1506X 00643169979475 217506615 EUP1506X 00643169979475 217576082 EUP1506X 00643169559813 217638054 EUP1506X 00643169559813 217833021 EUP1506X 00643169979475 217876349 EUP1510X 00643169559820 217225186 EUP1510X 00643169559820 217238070 EUP1510X 00643169618633 217262907 EUP1510X 00643169559820 217371289 EUP1510X 00643169979413 217396792 EUP1510X 00643169979413 217451079 EUP1510X 00643169979413 217473910 EUP1510X 00643169618633 217473911 EUP1510X 00643169979413 217518609 EUP1510X 00643169559820 217602408 EUP1510X 00643169559820 217610624 EUP1510X 00643169618633 217630776 EUP1510X 00643169559820 217656465 EUP1510X 00643169618633 217704793 EUP1510X 00643169979413 217704794 EUP1510X 00643169979413 217803293 EUP1510X 00643169559820 217804976 EUP1510X 00643169979413 217817346 EUP1510X 00643169979413 217939845 EUP1510X 00643169979413 217960062 EUP1512X 00643169979338 217282165 EUP1512X 00643169559837 217282749 EUP1512X 00643169559837 217290758 EUP1512X 00643169618558 217291003 EUP1512X 00643169618558 217396342 EUP1512X 00643169979338 217451080 EUP1512X 00643169559837 217518423 EUP1512X 00643169979338 217584296 EUP1512X 00643169618558 217728406 EUP1512X 00643169559837 217791032 EUP1512X 00643169618558 217803295 EUP1512X 00643169979338 217817347 EUP1512X 00643169559837 217833023 EUP1512X 00643169979338 217876348 EUP1515X 00643169618688 217216700 EUP1515X 00643169979468 217216702 EUP1515X 00643169559844 217225187 EUP1515X 00643169979468 217270937 EUP1515X 00643169979468 217291129 EUP1515X 00643169618688 217291133 EUP1515X 00643169559844 217379139 EUP1515X 00643169979468 217387047 EUP1515X 00643169618688 217396791 EUP1515X 00643169979468 217451566 EUP1515X 00643169618688 217518610 EUP1515X 00643169979468 217518611 EUP1515X 00643169979468 217584297 EUP1515X 00643169979468 217601078 EUP1515X 00643169979468 217630784 EUP1515X 00643169559844 217638060 EUP1515X 00643169559844 217727985 EUP1515X 00643169618688 217728244 EUP1515X 00643169618688 217775695 EUP1515X 00643169979468 217777586 EUP1515X 00643169559844 217786006 EUP1515X 00643169618688 217791230 EUP1515X 00643169979468 217960063 EUP1515X 00643169559844 217961583 EUP1520X 00643169559851 217253539 EUP1520X 00643169618923 217270929 EUP1520X 00643169979703 217270933 EUP1520X 00643169559851 217313635 EUP1520X 00643169979703 217339009 EUP1520X 00643169979703 217370779 EUP1520X 00643169979703 217387049 EUP1520X 00643169979703 217427611 EUP1520X 00643169979703 217444053 EUP1520X 00643169979703 217480193 EUP1520X 00643169559851 217488906 EUP1520X 00643169618923 217506621 EUP1520X 00643169979703 217518608 EUP1520X 00643169618923 217518614 EUP1520X 00643169979703 217577127 EUP1520X 00643169618923 217682939 EUP1520X 00643169618923 217775696 EUP1520X 00643169559851 217791033 EUP1520X 00643169559851 217875827 EUP2006X 00643169559868 217290755 EUP2006X 00643169559868 217325279 EUP2006X 00643169979574 217473906 EUP2006X 00643169979574 217506617 EUP2006X 00643169979574 217601073 EUP2006X 00643169559868 217602407 EUP2006X 00643169979574 217616434 EUP2006X 00643169559868 217646822 EUP2006X 00643169979574 217682942 EUP2006X 00643169618794 217721594 EUP2006X 00643169559868 217791029 EUP2006X 00643169559868 217913568 EUP2010X 00643169559875 217313603 EUP2010X 00643169559875 217371290 EUP2010X 00643169559875 217465238 EUP2010X 00643169618862 217490849 EUP2010X 00643169618862 217506623 EUP2010X 00643169559875 217535671 EUP2010X 00643169979642 217542638 EUP2010X 00643169979642 217557954 EUP2010X 00643169979642 217584304 EUP2010X 00643169979642 217602587 EUP2010X 00643169979642 217616444 EUP2010X 00643169559875 217656461 EUP2010X 00643169979642 217682944 EUP2010X 00643169559875 217728347 EUP2010X 00643169979642 217728410 EUP2010X 00643169559875 217860167 EUP2010X 00643169979642 217891539 EUP2012X 00643169979307 217225194 EUP2012X 00643169979307 217246462 EUP2012X 00643169979307 217270930 EUP2012X 00643169979307 217282164 EUP2012X 00643169979307 217291005 EUP2012X 00643169559882 217325272 EUP2012X 00643169618527 217339010 EUP2012X 00643169979307 217339011 EUP2012X 00643169559882 217339173 EUP2012X 00643169559882 217347821 EUP2012X 00643169559882 217379135 EUP2012X 00643169618527 217379610 EUP2012X 00643169979307 217379612 EUP2012X 00643169979307 217387051 EUP2012X 00643169618527 217387053 EUP2012X 00643169559882 217418683 EUP2012X 00643169559882 217465237 EUP2012X 00643169979307 217451567 EUP2012X 00643169559882 217479184 EUP2012X 00643169559882 217518421 EUP2012X 00643169559882 217535675 EUP2012X 00643169979307 217557965 EUP2012X 00643169979307 217584406 EUP2012X 00643169979307 217602590 EUP2012X 00643169979307 217630783 EUP2012X 00643169559882 217646823 EUP2012X 00643169559882 217668159 EUP2012X 00643169979307 217704795 EUP2012X 00643169559882 217713354 EUP2012X 00643169618527 217713408 EUP201… (truncated, 27676 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular Galway DBA Medtronic Ireland
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 3, 2019

Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC2530X, SLC27512X, SLC27515X, SLC27520X, SLC3010X, SLC3012X, SLC3015X, SLC3020X, SLC3025X, SLC3030X, SLC3506X, SLC3510X, SLC3512X, SLC3515X, SLC3520X, SLC3530X, SLC4010X, SLC4012X, SLC4015X, SLC4020X, SLC4025X, SLC4030X (OUS DISTRIBUTION ONLY)

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

ALL 50 STATES
Full report

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

Recall #:
83797
Lot/product code:
Product Number / CFN GTIN Lot SLC1506X 00643169680005 217427355 SLC1510X 00643169680012 217253572 SLC1510X 00643169680012 217298666 SLC1510X 00643169680012 217387126 SLC1510X 00643169680012 217427354 SLC1510X 00643169680012 217487816 SLC1512X 00643169680029 217218112 SLC1512X 00643169680029 217253582 SLC1512X 00643169680029 217387128 SLC1512X 00643169680029 217487818 SLC1512X 00643169680029 217542634 SLC1512X 00643169680029 217859789 SLC1515X 00643169680036 217246455 SLC1515X 00643169680036 217253577 SLC1515X 00643169680036 217306789 SLC1515X 00643169680036 217415822 SLC1515X 00643169680036 217427365 SLC1515X 00643169680036 217823443 SLC1515X 00643169680036 217859165 SLC1515X 00643169680036 217940024 SLC1520X 00643169680043 217253580 SLC1520X 00643169680043 217306787 SLC1520X 00643169680043 217427359 SLC1520X 00643169680043 217542633 SLC1520X 00643169680043 217646425 SLC1520X 00643169680043 217668582 SLC1520X 00643169680043 217799249 SLC1520X 00643169680043 217859164 SLC2006X 00643169680050 217435326 SLC2006X 00643169680050 217913786 SLC2010X 00643169680067 217253573 SLC2010X 00643169680067 217297545 SLC2010X 00643169680067 217387127 SLC2010X 00643169680067 217427356 SLC2010X 00643169680067 217646867 SLC2010X 00643169680067 217668585 SLC2010X 00643169680067 217676631 SLC2010X 00643169680067 217905820 SLC2012X 00643169680074 217253578 SLC2012X 00643169680074 217298670 SLC2012X 00643169680074 217306788 SLC2012X 00643169680074 217415824 SLC2012X 00643169680074 217434925 SLC2012X 00643169680074 217602539 SLC2012X 00643169680074 217668687 SLC2012X 00643169680074 217799250 SLC2012X 00643169680074 217859791 SLC2012X 00643169680074 217940066 SLC2015X 00643169680081 217218115 SLC2015X 00643169680081 217253574 SLC2015X 00643169680081 217271254 SLC2015X 00643169680081 217298669 SLC2015X 00643169680081 217306223 SLC2015X 00643169680081 217404046 SLC2015X 00643169680081 217418812 SLC2015X 00643169680081 217418907 SLC2015X 00643169680081 217427706 SLC2015X 00643169680081 217435327 SLC2015X 00643169680081 217498815 SLC2015X 00643169680081 217615647 SLC2015X 00643169680081 217646871 SLC2015X 00643169680081 217668584 SLC2015X 00643169680081 217713076 SLC2015X 00643169680081 217721607 SLC2015X 00643169680081 217777612 SLC2015X 00643169680081 217799251 SLC2015X 00643169680081 217884509 SLC2015X 00643169680081 217913790 SLC2020X 00643169680098 217218110 SLC2020X 00643169680098 217246457 SLC2020X 00643169680098 217253575 SLC2020X 00643169680098 217271253 SLC2020X 00643169680098 217298667 SLC2020X 00643169680098 217306220 SLC2020X 00643169680098 217387130 SLC2020X 00643169680098 217404047 SLC2020X 00643169680098 217418908 SLC2020X 00643169680098 217487822 SLC2020X 00643169680098 217498821 SLC2020X 00643169680098 217676628 SLC2020X 00643169680098 217713075 SLC2020X 00643169680098 217727927 SLC2020X 00643169680098 217799252 SLC2020X 00643169680098 217850364 SLC2020X 00643169680098 217905822 SLC2025X 00643169680104 217271251 SLC2025X 00643169680104 217542635 SLC2025X 00643169680104 217905821 SLC2030X 00643169680111 217218119 SLC2030X 00643169680111 217427363 SLC2030X 00643169680111 217602538 SLC2030X 00643169680111 217704778 SLC2030X 00643169680111 217777614 SLC22510X 00643169680135 217487815 SLC22510X 00643169680135 217646423 SLC22515X 00643169680159 217427362 SLC22515X 00643169680159 217646422 SLC22520X 00643169680166 217721606 SLC22520X 00643169680166 217913787 SLC22525X 00643169680173 217415820 SLC22525X 00643169680173 218025488 SLC2506X 00643169680180 217823441 SLC2510X 00643169680197 217218122 SLC2510X 00643169680197 217401003 SLC2510X 00643169680197 217427357 SLC2510X 00643169680197 217693881 SLC2510X 00643169680197 217913792 SLC2510X 00643169680197 218034774 SLC2512X 00643169680203 217271257 SLC2512X 00643169680203 217306225 SLC2512X 00643169680203 217415825 SLC2512X 00643169680203 217434924 SLC2512X 00643169680203 217498822 SLC2512X 00643169680203 217606584 SLC2512X 00643169680203 217695006 SLC2512X 00643169680203 217859787 SLC2512X 00643169680203 217913793 SLC2515X 00643169680210 217253581 SLC2515X 00643169680210 217306786 SLC2515X 00643169680210 217401005 SLC2515X 00643169680210 217418813 SLC2515X 00643169680210 217418906 SLC2515X 00643169680210 217427709 SLC2515X 00643169680210 217487819 SLC2515X 00643169680210 217498813 SLC2515X 00643169680210 217542636 SLC2515X 00643169680210 217602540 SLC2515X 00643169680210 217646866 SLC2515X 00643169680210 217693884 SLC2515X 00643169680210 217859788 SLC2515X 00643169680210 217905823 SLC2515X 00643169680210 218045287 SLC2520X 00643169680227 217271256 SLC2520X 00643169680227 217387129 SLC2520X 00643169680227 217404048 SLC2520X 00643169680227 217418909 SLC2520X 00643169680227 217434922 SLC2520X 00643169680227 217487821 SLC2520X 00643169680227 217498819 SLC2520X 00643169680227 217542632 SLC2520X 00643169680227 217646868 SLC2520X 00643169680227 217695009 SLC2520X 00643169680227 217859162 SLC2520X 00643169680227 217913794 SLC2525X 00643169680234 217218108 SLC2525X 00643169680234 21767558… (truncated, 7598 characters total — see the official FDA record for the full value)
Recalling firm:
Medtronic Vascular Galway DBA Medtronic Ireland
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2019

Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

ALL 50 STATES
Full report

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

Recall #:
83692
Lot/product code:
UDI (01)00858164002190(10) 5.40.00
Recalling firm:
Elekta Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 4, 2019

Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review

It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.

ALL 50 STATES
Full report

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

Recall #:
83692
Lot/product code:
UDI: (01)00858164002244(10) 5.50.00  (01)00858164002268(10) 5.51.00
Recalling firm:
Elekta Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 6, 2019

MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures.

The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.

ALL 50 STATES
Full report

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

Recall #:
83740
Lot/product code:
14G1
Recalling firm:
Medline Industries Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

ALL 50 STATES
Full report

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

Recall #:
83980
Lot/product code:
Touchscreen Serial Number: 41088-1808-0001 to 0179,  41213-1809-0001 to 0200,  41305-1811-0001 to 0295,  41379-1812-0001 to 0250,  41379-1812-0251 to 0328,  41540-1813-0001 to 0195,  41633-1814-0001 to 0275,  41633-1814-0276 to 0285,  41724-1815-0001 to 0140,  41724-1815-0141 to 0183,  41838-1816-0001 to 0107,  41838-1816-0108 to 0165,  41930-1817-0001 to 0092,  42059-1818-0001 to 0150,  42059-1818-0151 to 0183,  42161-1819-0001 to 0117,  42161-1819-0118 to 0137,  42232-1820-0001 to 0130,  42232-1820-0131 to 0146,  42334-1822-0001 to 0134,  42334-1822-0135 to 0141,  42471-1823-0001 to 0143,  42471-1823-0144 to 0175,  42805-1828-0001 to 0138
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N: 453561528931, 453561528941, 453561536451, 453561536461

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

ALL 50 STATES
Full report

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

Recall #:
83980
Lot/product code:
Serial Numbers: 100270400, 100270407, 100256220, 100270404, 100263004, 100266507, 100270402, 100263001, 100263009, 100258193, 100258197, 100258883, 100262978, 100263006, 100258196, 100256196, 100256197, 100256198, 100263003, 100266499, 100266505, 100258889, 100256192, 100258887, 100266509, 100270408, 100262976, 100258881, 100258880, 100266511, 100270406, 100258885, 100256223, 100263000, 100258884, 100258888, 100266500, 100266504, 100258886, 100256222, 100256195, 100256199, 100266502, 100266508, 100266510, 100270403, 100270490, 100257708, 100257713, 100257716, 100256831, 100256834, 100256837, 100262373, 100262556, 100262575, 100265136
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 4/13/15 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Ultrasound Transducer (M2736A), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips M2736A Avalon Smart Ultrasound Bottom Case, NFPHA9515

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 9/2/15 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Respironics V680 Ventilator, Service # 850011, (OUS Only)

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

ALL 50 STATES
Full report

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

Recall #:
83980
Lot/product code:
Serial Numbers: 100255874, 100255957, 100257487, 100257488, 100257490, 100257491, 100257493, 100257494, 100257495, 100257496, 100257497, 100257498, 100257499, 100257500, 100257501, 100258060, 100258061, 100258063, 100258064, 100258065, 100258066, 100258067, 100258068, 100260220, 100260221, 100260222, 100260223, 100260224, 100260227, 100260228, 100260229, 100260616, 100260617, 100260618, 100260619, 100260620, 100260621, 100260622, 100260623, 100260624, 100260625, 100260626, 100260627, 100260628, 100260629, 100260630, 100260631, 100260632, 100260633, 100260634, 100260635, 100261843, 100261844, 100261845, 100261846, 100261847, 100261848, 100261849, 100261850, 100261851, 100261852, 100261853, 100261854, 100261855, 100261856, 100261857, 100261900, 100261901, 100261902, 100263992, 100263993, 100263994, 100263995, 100263996, 100263997, 100263998, 100263999, 100264020, 100264021, 100264022, 100264023, 100264024, 100264025, 100264026, 100264279, 100264300, 100264301, 100264302, 100264303, 100264561, 100264562, 100264563, 100264564, 100264565, 100264566, 100264567, 100264568, 100264569, 100264570, 100264571, 100264572, 100264573, 100264574, 100264575, 100264576, 100264577, 100264578, 100264579, 100264780, 100264781, 100264782, 100264783, 100264784, 100264785, 100265624, 100265625, 100265626, 100265627, 100265628, 100265629, 100265630, 100265631, 100265632, 100265633, 100265634, 100265635, 100265636, 100265637, 100265638, 100265639, 100265640, 100265641, 100265642, 201034917, 201034918, 201034919, 201034945, 201034946, 201034947, 201034949, 201034950, 201034951, 201034952, 201034953, 201034954, 201035015, 201035016, 201035017, 201035018, 201035019, 201035080, 201035081, 201035082, 201035083, 201035084, 201035085, 201035197, 201035198, 201035199, 201035221, 201035222, 201035223, 201035224, 201035225, 201035226, 201035320, 201035321, 201035322, 201035323, 201035324, 201035325, 201035326, 201035328, 201035329, 201035330, 201035331, 201035332, 201035333, 201035334, 201035335, 201035336, 201035337, 201035338, 201035339, 201035360, 201035361, 201035362, 201035363, 201035364, 201035365
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 10/20/14 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 9/2/15 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

ALL 50 STATES
Full report

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

Recall #:
83980
Lot/product code:
Serial Numbers: 100005249 100254792 100255723 100255865 100256311 100256502 100256609 100256781 100256875 100257173 100257312 100257583 100257698 100258034 100258360 100258513 100258809 100259082 100259249 100259633 100259878 100260186 100260534 100260846 100261115 100261278 100261538 100261743 100262170 100262417 100262531 100262627 100262821 100007779 100254793 100255724 100255866 100256312 100256503 100256610 100256782 100256876 100257174 100257313 100257584 100257699 100258035 100258361 100258514 100258810 100259083 100259250 100259634 100259879 100260231 100260535 100260847 100261117 100261279 100261539 100261744 100262171 100262418 100262532 100262628 100262822 100007982 100254977 100255725 100255965 100256313 100256504 100256611 100256783 100256877 100257175 100257314 100257585 100257800 100258159 100258362 100258553 100258811 100259085 100259251 100259635 100259880 100260233 100260537 100260849 100261120 100261302 100261540 100261745 100262172 100262419 100262533 100262629 100262823 100008795 100255098 100255726 100255966 100256314 100256505 100256612 100256784 100256980 100257176 100257316 100257586 100257801 100258211 100258363 100258554 100258812 100259086 100259252 100259636 100259881 100260234 100260538 100260850 100261121 100261320 100261541 100261746 100262173 100262420 100262534 100262630 100262824 100009556 100255165 100255727 100255967 100256315 100256507 100256613 100256785 100256981 100257177 100257317 100257587 100257802 100258240 100258364 100258556 100258813 100259087 100259253 100259724 100259882 100260235 100260539 100260851 100261122 100261321 100261543 100261747 100262174 100262421 100262535 100262631 100262825 100010513 100255317 100255728 100255968 100256316 100256508 100256614 100256786 100256982 100257178 100257318 100257588 100257803 100258241 100258365 100258557 100258814 100259088 100259255 100259726 100259996 100260236 100260540 100260852 100261123 100261322 100261544 100261748 100262175 100262422 100262536 100262632 100262826 100011641 100255318 100255729 100255969 100256317 100256509 100256615 100256842 100256983 100257179 100257319 100257589 100257804 100258242 100258366 100258558 100258817 100259089 100259256 100259732 100259997 100260237 100260541 100260853 100261124 100261365 100261545 100261749 100262176 100262423 100262537 100262633 100262827 100015789 100255409 100255730 100255970 100256318 100256510 100256616 100256843 100256984 100257200 100257377 100257590 100257805 100258243 100258367 100258559 100258818 100259090 100259258 100259735 100259998 100260238 100260542 100260854 100261125 100261366 100261546 100261750 100262177 100262424 100262539 100262634 100262828 100020831 100255421 100255732 100255971 100256319 100256511 100256617 100256844 100256985 100257201 100257378 100257591 100257806 100258244 100258368 100258587 100258819 100259091 100259259 100259737 100259999 100260239 100260545 100260855 100261126 100261367 100261547 100261751 100262178 100262426 100262540 100262635 100262829 100021459 100255422 100255733 100255972 100256395 100256512 100256618 100256845 100256986 100257202 100257379 100257592 100257807 100258245 100258450 100258588 100258820 100259092 100259260 100259783 100260020 100260240 100260546 100260856 100261127 100261368 100261549 100261752 100262179 100262427 100262541 100262637 100262830 100021751 100255424 100255734 100255973 100256396 100256513 100256619 100256846 100256987 100257203 100257380 100257593 100257808 100258246 100258451 100258589 100258821 100259093 100259261 100259784 100260021 100260241 100260547 100260857 100261128 100261369 100261550 100261753 100262180 100262429 100262543 100262638 100262832 100023634 100255500 100255737 100255974 100256398 100256514 100256620 100256847 100256988 100257204 100257381 100257670 100257809 100258247 100258452 100258590 100258822 100259094 100259262 100259785 100260022 100260242 100260548 100260858 100261129 100261370 100261551 100261754 100262181 100262431 100262544 100262639 100262833 100023729 100255501 100255738 100255975 100256399 100256515 100256621 100256848 100256990 100257205 100257382 100257671 100257811 100258248 100258453 100258591 100258823 100259095 100259263 100259786 100260024 100260243 100260549 100260951 100261130 100261371 100261552 100261755 100262182 100262432 100262546 100262640 100262834 100026949 100255502 100255739 100255976 100256400 100256516 100256623 100256849 100256991 100257206 100257383 100257672 100257812 100258249 100258454 100258592 100258920 100259096 100259380 100259788 100260025 100260244 100260550 100260953 100261131 100261372 100261553 100261756 100262183 100262433 100262547 100262641 100262835 100029508 100255504 100255840 100256005 100256401 100256517 100256624 100256850 100257085 100257207 100257384 100257673 100257813 100258250 100258455 100258593 100258921 100259097 100259381 100259791 100260026 100260245 100260551 100260955 100261132 100261373 100261554 100261757 100262184 100262434 100262548 100262642 100262836 100034162 100255506 100255841 1002… (truncated, 28175 characters total — see the official FDA record for the full value)
Recalling firm:
Respironics California, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 9/2/15 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilus Ultrasound Bottom Case, NFCM9515, Pacific Medical GE Corometrics Nautilus Ultrasound Cable Assembly, NFCM9520; Pacific Medical GE Corometrics Nautilus Ultrasound Crystal, NFCM9535

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 12/18/14 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical Philips M1355A Toco Gauge, NFPH9340

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 10/20/14 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 9/2/15 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical Philips M1356A Ultrasound Cable Assembly, NFPH9520; Pacific Medical Philips M1356A Ultrasound M1356A Crystal, NFPH9535

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 12/18/14 and 4/2/19.
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 11, 2019

Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific Medical GE Corometrics Nautilus TOCO Coil with Screws, NFCM9325

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

ALL 50 STATES
Full report

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

Recall #:
83610
Lot/product code:
All serial numbers serviced between 1/19/15 and 4/2/19
Recalling firm:
Pacific Medical Group Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 12, 2019

Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack

Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate

ALL 50 STATES
Full report

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

Recall #:
83826
Lot/product code:
Lot number: 494604
Recalling firm:
Olympus Corporation of the Americas
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled September 13, 2019

The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

ALL 50 STATES
Full report

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

Recall #:
83889
Lot/product code:
Software version VG4.1.1/VG4.0.3 and lower
Recalling firm:
Draegar Medical Systems, Inc.
View official FDA record (opens in a new tab)