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Recalls affecting Georgia

Data last updated: September 10, 2026 at 1:16 PM UTC

17,404 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

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Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

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Food & Beverages

Recalling firm: American Regent, Inc.

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

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

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

Undeclared milk

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Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" 1.5 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3204  UDIs: 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242  Batch Numbers: U0495, U0498, U0496, U0497, U0420, A0902, A0903
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" 1.5 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3203  UDIs: 07290104830198, 07290104830198, 07290104830198, 07290104830198  Batch Numbers: U0382, A6775, A1875, A0575
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" 1.5 i-Thaw" Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR4009  UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204  Batch Numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures.

The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

ALL 50 STATES
▸Full report

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

Recall #:
86846
Lot/product code:
Serial Numbers: 40AD58C55001, 40AD58C4B001, 40AD58C24001, 40AD58522001, 40AD58C1C001, 101X968101, 091X955901
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSphere" 1.5 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3560  UDIs: 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945  Batch Numbers: U1454, U1455, U1456, U1420, U1421, U1325, U1326, U1328, U1327, U0435, U0432, U0369, U0351, U0352, T0403, T0402, T0395, T0394, T0305, T0146, T0126, T0006, T0023, T0024, T0018, T0015, A7205, A6966, A6967, A6969, A6968, A6943, A6942, A6917, A6918, A2089, A2090, A1858, A1857, A1848, A1847, A1823, A1824, A1819, A1818, A1811, A1812, A1801, A1802, A1794, A1793, A1785, A1786, A1601, A1602, A1591, A1592, A1489, A1490, A1477, A1478, A1309, A1308, A1294, A1295, A1293, A1292, A1265, A1264, A1250, A1251, A1242, A1241
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSphere" 1.5 S 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3561  UDIs: 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556  Batch Numbers: U1176, U1175, U0460, U0459, U0157, T0702, T0389, T0390, T0371, T0370, T0064, T0065, T0045, T0044, A7075, A7074, A6873, A6872, A1632, A1633, A1616, A1615, A1363, A1364
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSeed" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR4518  UDIs: 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075  Batch Numbers: U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" 1.5 PLUS 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3508  UDIs: 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563  Batch Numbers: U1442, U1443, U1435, U1434, U1371, U1372, U1360, U1361, U1020, U1038, U1019, U1017, U1018, U0436, U0392, U0373, U0372, U0327, U0333, U0336, U0334, U0335, U0332, U0329, U0330, U0294, U0289, U0291, U0292, U0290, U0293, U0212, U0213, U0061, U0063, U0044, U0043, U0006, U0007, T0499, T0498, T0342, T0340, T0341, T0328, T0314, T0300, T0298, T0299, T0115, T0116, T0111, T0112, T0068, T0069, T0052, T0053, T0034, T0035, A7228, A7227, A7185, A7184, A7169, A7170, A7171, A7168, A7132, A7133, A7123, A7028, A7029, A7000, A7001, A6971, A6970, A6950, A6951, A6792, A6793, A6778, A6777, A6771, A6772, A6736, A6735, A6699, A6700, A6692, A6693, A6685, A6686, A6665, A6666, A6662, A6661, A6653, A6654, A2115, A2114, A2098, A2097, A2048, A2022, A2009, A2007, A2008, A2006, A1997, A1985, A1984, A1898, A1897, A1830, A1831, A1821, A1822, A1816, A1817, A1808, A1807, A1663, A1664, A1655, A1656, A1593, A1480, A1481, A1456, A1457, A1450, A1451, A1410, A1411, A1367, A1239, A1240, A1237, A1238, A1212, A1213
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" 1.5 PLUS Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3510  UDIs: 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570  Batch Numbers: U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, A1531
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSeed" 1.5 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3202  UDIs: 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235  Batch Numbers: U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, A0284
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" 1.5 CX 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3533  UDIs: 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 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7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587… (truncated, 12377 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IcePearl" 2.1 CX Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3603  UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010  Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceFORCE" 2.1 CX Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3605  UDIs: 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034  Batch Numbers: U1030, U0904, U0864, U0856, U0763, U0649, T0153, A7062, A7061, A6930, A6758, A1781, A1776, A1565, A1550, A1435, A1291
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceFORCE" 2.1 CX Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3604  UDIs: 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027   Batch Numbers: U0903, U0785, U0617, U0042, T0166, T0156, A7083, A6931, A6928, A6916, A6734, A1549, A1527, X1483, A1203
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IcePearl" 2.1 CX 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3601  UDIs: 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 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7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990… (truncated, 9627 characters total — see the official FDA record for the full value)
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IcePearl" 2.1 CX Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3606  UDIs: 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041  Batch Numbers: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSeed" 1.5 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3201  UDIs: 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181  Batch Numbers: U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, A0574
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3608  UDIs: 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065  Batch Numbers: U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceFORCE" 2.1 CX L 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3618  UDIs: 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089  Batch Numbers: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceRod" i-Thaw" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR4070  UDIs: 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105  Batch Numbers: U1363, U0865, U0555, U0542, U0151, U0150, U0054, U0053, U0046, U0037, U0036, T0633, T0515, T0430, T0274, T0273, T0201, T0188, T0167, A7174, A7100, A7044, A7022, A7021, A6788, A6740, A2117, A2019, A1968, A1753, A1605, A1535, A1430, A1429, A1235, U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225, G5063, G5871, G5900, G5902, G5975, P1901
Recalling firm:
Boston Scientific Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

Five IceRod" i-Thaw" Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3571  UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976  Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSphere" 1.5 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3258   UDI: 07290104830211  Batch Number: A0125
Recalling firm:
Boston Scientific Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

Trinias, Digital Angiography System containing a MH-200, Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

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

Recall #:
86846
Lot/product code:
Affected Serial Numbers: 41EFCD7A6001 41EFC73A5001, 41EFCD79C001, 41EFD3B9C001, 41EFFF79C001, 41EFD3B9A001, 41EFCD79A001, 41EFFF79A001, 41F005B91001, 41F005B8C001, 41EFCD78B001, 41EFCD77C001, 41E58C776001, 41E58C777001, 41E58C775001, 41E58C773001, 41E58C76B001, 41E58C769001, 41E58C766001, 41E58C765001, 41E58C757001, 41B24774C001, 41B247746001,
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

IceSphere" 1.5 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

ALL 50 STATES
▸Full report

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

Recall #:
86777
Lot/product code:
UPN: FPRPR3260  UDIs: 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259  Batch Numbers: U0326, U0325, U0286, U0285, A7012, A7011
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 18, 2020

MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

The firm has identified a problem with the control software for the celling arm of the X-Ray System . This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could result in possible collision or harm to the patient or system operator.

ALL 50 STATES
▸Full report

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

Recall #:
86846
Lot/product code:
Affected Serial Numbers: 0161K35901, 0161K46901, 0161K58202, 0161K56001, 0161K55702, 0161K55301, 0161K55202, 0161K47102, 0161K46802, 0161K46301, 0161K36501, 0161K36301, 0161K35702, 0161K36202, 40AAE701B001, 0161K49301, 0161K48601, 0161K48501, 0161K36402, 0161K35602, 0161K35202, 0161K56502
Recalling firm:
Shimadzu Medical Systems
View official FDA record (opens in a new tab)