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Recalls affecting Pennsylvania

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

17,283 recalls found
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Just announced

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

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

Products contain undeclared yohimbine

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Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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)

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Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

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Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled July 14, 2021

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10144 4

CGMP Deviations

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

Recall #:
D-0841-2021
Lot/product code:
All lots within expiry.
Recalling firm:
Johnson & Johnson Consumer, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2021

Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6

CGMP Deviations

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

Recall #:
D-0850-2021
Lot/product code:
All lots within expiry
Recalling firm:
Johnson & Johnson Consumer, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 14, 2021

Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858, UPC 0 86800 10037 9

CGMP Deviations

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▸Full report

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

Recall #:
D-0835-2021
Lot/product code:
All lots within expiry.
Recalling firm:
Johnson & Johnson Consumer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 14, 2021

Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK

Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

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

Recall #:
88440
Lot/product code:
All devices distributed by Pentax in the US between April 2014 and May 2021
Recalling firm:
Pentax of America Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2021

Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.

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

Recall #:
88287
Lot/product code:
Item/Lot: 324M-15/0000116695, 324M-16/0000116696
Recalling firm:
Cell Marque Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 15, 2021

(1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)

The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)

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

Recall #:
93739
Lot/product code:
(1) Ingenia Ambition X UDI-DI 00884838090040 Serial Numbers 47000 47001 47002 47003 47004 47006 47007 47009 47011 47012 47013 47014 47015 47016 47017 47018 47019 47020 47022 47023 47024 47025 47026 47027 47028 47029 47030 47032 47033 47034 47035 47037 47038 47039 47040 47041 47043 47044 47045 47047 47048 47049 47050 47051 47052 47053 47054 47056 47057 47058 47059 47060 47061 47062 47063 47064 47065 47066 47067 47068 47070 47071 47072 47074 47075 47077 47078 47080 47081 47082 47083 47084 47085 47088 47089 47091 47092 47093 47094 47095 47096 47097 47098 47099 47174 47175 47177 47183 47184 47187 47188 47190 47192 47193 47194 47195 47196 47197 47198 47199 47202 47203 47206 47208 47209 47211 47215 47216 47219 47220 47221 47225 47226 47227 47244 47245 47247 47248 47252 47255 47258 47260 47262 47268 47269 47270 47271 47272 47275 47276 47279 47284 47297 47298 47282 (2) Ingenia Ambition S UDI-DI 00884838090057 Serial Numbers 48000 48001 48003 48004 48005 48009 48010 48011 48012 48013 48014 48015 48016 48017 48018 48019 48020 48022 48023 48026 48027 48028 48031 48032 48033 48034 48035 48036 48037 48038 48039 48040 48043 48044 48045 48046 48047 48049 48050 48051 48052 48053 48055 48056 48112 48120 48122 48127 48128 48129 48130 48131 48133 48134 48136 48144 48148 48151 48152 48153 48154 48155 48158 48160 48162 48166 48167 48169 48171 48172 48173 48174 48179 48180 48181 48182 48183 48184 48186 48187 48188 48190 48191 48192 48194 48196 48198 48199 48200 48207
Recalling firm:
Philips North America
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2021

RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

ALL 50 STATES
▸Full report

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

Recall #:
88353
Lot/product code:
a) 504550, Lot Numbers: KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21A2076, KME21A2787, KME21B1140, KME21C0059, KME21C2363 b) 504555, Lot Numbers: KME20K0765, KME20K0766, KME20K0935, KME20K1582, KME20L0619, KME20L1857, KME20L2028, KME20M0020, KME21A1902, KME21A2796, KME21B2681, KME21C2707 c) 504560, Lot Numbers: KME20K1550, KME20L0336, KME20L2298, KME20M0021, KME20M0492, KME21A0380, KME21A0817, KME21A1160, KME21A1770, KME21B1137, KME21B1138, KME21B1139, KME21C3255 d) 504565, Lot Numbers: KME20K0465, KME20K0939, KME20K1551, KME20K1628, KME20K2246, KME20L0488, KME20L1840, KME20M0022, KME20M0854, KME20M1102, KME20M1579, KME21A0085, KME21A1040, KME21A1292, KME21A2794, KME21B1141, KME21B1669, KME21B2155, KME21B2501, KME21B2502, KME21B2855, KME21C0025, KME21C1202, KME21C1331, KME21C1790, KME21C1897, KME21C2188, KME21C2262, KME21C2835 e) 504570, Lot Numbers: KME20K0026, KME20K0360, KME20K0361, KME20K0768, KME20K0941, KME20K1148, KME20K1202, KME20K1304, KME20K1552, KME20K1658, KME20K2057, KME20K2187, KME20K3161, KME20K3355, KME20L0057, KME20L0059, KME20L0490, KME20L0623, KME20L0943, KME20L0944, KME20L1091, KME20L1122, KME20L1124, KME20L1475, KME20L1844, KME20L2039, KME20L2258, KME20L2827, KME20M0378, KME20M0379, KME20M0380, KME20M0498, KME20M1105, KME20M1153, KME20M1156, KME21A0228, KME21A0273, KME21A0304, KME21A0305, KME21A1769, KME21A2227, KME21A2228, KME21A2229, KME21A2263, KME21A3119, KME21A3120, KME21A3121, KME21B0261, KME21B0338, KME21B0559, KME21B0750, KME21B1073, KME21B1751, KME21B2107, KME21B2153, KME21B2460, KME21B2719, KME21B2721, KME21C0123, KME21C0376, KME21C0421, KME21C0620, KME21C0634, KME21C1016, KME21C1333, KME21C1416, KME21C1434, KME21C1489, KME21C1593, KME21C1653, KME21C1703, KME21C1786, KME21C1896, KME21C2065, KME21C2146 f) 504575, Lot Numbers: KME20K0769, KME20K0770, KME20K1150, KME20K1204, KME20K1665, KME20K2188, KME20K2920, KME20K3016, KME20K3018, KME20K3159, KME20K3575, KME20L1476, KME20L2374, KME20M0383, KME20M1151, KME20M2051, KME20M2344, KME20M2376, KME20M2485, KME20M2556, KME21A0084, KME21A0303, KME21A0671, KME21A0672, KME21A0673, KME21A0674, KME21A0812, KME21A1041, KME21A1464, KME21A1605, KME21A2799, KME21A2815, KME21B0753, KME21B0814, KME21B0888, KME21B0889, KME21B0931, KME21B1240, KME21B2461, KME21B2462, KME21B2465, KME21B2716, KME21B2717, KME21C0700, KME21C0972, KME21C1203, KME21C1336, KME21C1435, KME21C1893, KME21C2565, KME21C2610 g) 504580, Lot Numbers: KME20K0449, KME20K0450, KME20K1414, KME20K2622, KME20L1277, KME20L1479, KME20L2302, KME20L2828, KME20M1752, KME20M1753, KME21A0381, KME21A0820, KME21A0823, KME21A1291, KME21A1604, KME21B0339, KME21B1241, KME21B1855, KME21B2108, KME21B2154, KME21B2697, KME21C0377, KME21C0623, KME21C2407, KME21C2738, KME21C3448 f) 504585, Lot Numbers: KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21A0891, KME21A1043, KME21A2802, KME21A2803, KME21B0933, KME21B1250, KME21B1251, KME21B2029, KME21C0506, KME21C2107, KME21C2339, KME21C2341, KME21C2553, KME21D0210 g) 504590, Lot Numbers: KME20L0626, KME20M0856, KME20M2091, KME21C0299, KME21C2104, KME21C2105
Recalling firm:
Teleflex Medical Europe Ltd
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled July 16, 2021

ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)

Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

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

Recall #:
D-0001-2022
Lot/product code:
All lots within expiry
Recalling firm:
Alpha-Tek LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2021

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

ALL 50 STATES
▸Full report

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

Recall #:
88353
Lot/product code:
a) 170050, Lot Numbers: KME20K2551, KME20L1089, KME20L2371, KME21A2064, KME21B2498, KME21C0488 b) 170055, Lot Numbers: KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21A0383, KME21A1901, KME21B2682, KME21C2708 c) 170060, Lot Numbers: KME20L1487, KME20L2379, KME20M0494, KME21A0384, KME21A1482, KME21C0293 d) 170065, Lot Numbers: KME20K0938, KME20K2623, KME20L0487, KME20L1705, KME20M1578, KME20M1751, KME20M2709, KME21A0385, KME21A1812, KME21B1670, KME21B2499, KME21B2500, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 e) 170070, Lot Numbers: KME20K2544, KME20L0053, KME20L0055, KME20L0942, KME20L2372, KME20M0381, KME20M0665, KME20M1103, KME20M1754, KME20M1755, KME21A0893, KME21A2264, KME21B1074, KME21B1075, KME21C0463, KME21C0464, KME21C1027, KME21C1422, KME21C1592, KME21C2266, KME21C2504, KME21C2706, KME21D1043 f) 170075, Lot Numbers: KME20K1352, KME20L1132, KME20M0033, KME20M0382, KME20M1149, KME20M1225, KME20M1227, KME20M1537, KME20M2881, KME20M2882, KME21A0824, KME21A1161, KME21A1813, KME21B0813, KME21C0212, KME21C0213, KME21C1594, KME21C1895, KME21C2855, KME21C3294, KME21C3295 g) 170080, Lot Numbers: KME20L0396, KME20L1278, KME20L1279, KME20L2830, KME20M0847 , KME21A0386, KME21A2800, KME21A2801, KME21B1245, KME21B1752, KME21B2156, KME21C0465, KME21C0533, KME21C2826 h) 170085, Lot Numbers: KME20L0398, KME20L2376, KME20M3247, KME21A1894, KME21C0298, KME21C2385 i) 170090, Lot Numbers: KME20L0625 j) 170095, Lot Numbers: KME20M0384, KME21B0407
Recalling firm:
Teleflex Medical Europe Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2021

RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

ALL 50 STATES
▸Full report

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

Recall #:
88353
Lot/product code:
a) 112080050, Lot Numbers: KME20K1512, KME20L1145, KME20M2383, KME21B0357 b) 112080055, Lot Numbers: KME20K2579, KME21A2569, KME21C1978 c) 112080060, Lot Numbers: KME20M0616, KME20M2112, KME21A2685 d) 112080065, Lot Numbers: KME20K2581, KME21C1701 e) 112080070, Lot Numbers: KME20K2577, KME20L1985, KME20M1771, KME20M1772, KME20M2856, KME21A2355, KME21B1624, KME21B2490, KME21C1184 f) 112080075, Lot Numbers: KME20K0110 g) 112080080, Lot Numbers: KME20M0377, KME21B2727, KME21C0500 h) 112080085, Lot Numbers: KME20M0909, KME21B0519, KME21C0067 i) 112080090, Lot Numbers: KME20K1808, KME20L2352, KME20M2248 j) 112080095, Lot Numbers: KME20K2310, KME20L1153 k) 112080100 Lot Numbers: KME20K1005, KME20L1144
Recalling firm:
Teleflex Medical Europe Ltd
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2021

RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100

The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.

ALL 50 STATES
▸Full report

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

Recall #:
88353
Lot/product code:
a) 112082050, Lot Numbers: KME20K0211, KME20K0463, KME21A2017, KME21A2343, KME21A2686, KME21B2491 b) 112082055, Lot Numbers: KME20K0464, KME20K0683, KME20L1703, KME20M0996, KME21A0492, KME21A1433, KME21C0502, KME21C1347, KME21C1496, KME21C2745, KME21D0835 c) 112082060, Lot Numbers: KME20K0435, KME20K1112, KME20K2168, KME20K3530, KME20L0196, KME20L1143, KME20L1420, KME20L2089, KME20L2783, KME20M0497, KME20M0663, KME20M1064, KME20M1143, KME20M1218, KME21A1521, KME21A1803, KME21A2066, KME21A2344, KME21B0252, KME21B1151, KME21B1592, KME21B2606, KME21B2729, KME21C0483, KME21C1094, KME21C2681, KME21C2996, KME21D0703, KME21D1159, KME21D1326 d) 112082065, Lot Numbers: KME20K0036, KME20K0259, KME20K0436, KME20K0504, KME20K0677, KME20K0881, KME20L1421, KME20L1436, KME20L2349, KME20L2447, KME20L2448, KME20M0710, KME20M0892, KME20M0928, KME20M1806, KME20M1923, KME20M2249, KME20M2450, KME20M2708, KME21A0338, KME21A0404, KME21A0695, KME21A1588, KME21A1779, KME21A2102, KME21A2230, KME21A2572, KME21B1352, KME21B2607, KME21B2789, KME21B2856, KME21C0504, KME21C0981, KME21C0983, KME21C1035, KME21C1036, KME21C1097, KME21C1925, KME21C2997, KME21C3166, KME21C3456 e) 112082070, Lot Numbers: KME20J2802, KME20K0061, KME20K0437, KME20K0462, KME20K0585, KME20K1007, KME20K3013, KME20K3014, KME20K3145, KME20K3365, KME20K3448, KME20K3518, KME20K3560, KME20L0276, KME20L0371, KME20L0785, KME20L0928, KME20L1691, KME20L1752, KME20L1858, KME20L1874, KME20L1923, KME20L2111, KME20L2210, KME20L2273, KME20L2350, KME20L2373, KME20L2463, KME20L2478, KME20L2499, KME20L2699, KME20L2826, KME20M0490, KME20M0664, KME20M0712, KME20M0762, KME20M0774, KME20M0839, KME21A1121, KME21A1215, KME21A1328, KME21A2220, KME21A2345, KME21A2574, KME21A2984, KME21A3038, KME21B0136, KME21B0711, KME21B2898, KME21C0505, KME21C0567, KME21C0701, KME21C0737, KME21C0822, KME21C0854, KME21C0971, KME21C0973, KME21C1279, KME21C1328, KME21C1655, KME21C1702, KME21C2150, KME21C2403, KME21C2568, KME21C2875, KME21C2954, KME21D0350, KME21D0435, KME21D0491, KME21D0714, KME21D0715, KME21D1218, KME21D1409 f) 112082075, Lot Numbers: KME20J3284, KME20K0052, KME20K0181, KME20K1113, KME20K3044, KME20K3577, KME20L0484, KME20L0755, KME20L1092, KME20L1156, KME20L1298, KME20L1299, KME20L1704, KME20L1924, KME20L1983, KME20L2605, KME20L2798, KME20M0034, KME20M0321, KME20M1067, KME20M1507, KME20M1890, KME20M2212, KME21A3004, KME21A3259, KME21B0179, KME21B0823, KME21B2480, KME21B2482, KME21C0239, KME21C0264, KME21C0614, KME21C0615, KME21C0661, KME21C0702, KME21C0730, KME21C0826, KME21C0855, KME21C1093, KME21C1223, KME21C1323, KME21C1399, KME21C1601, KME21C1704, KME21C1746, KME21C1944, KME21C2008, KME21C2026, KME21C2051, KME21C2066, KME21C2195, KME21C2499, KME21C2615, KME21C2680, KME21C2766, KME21C2908, KME21C2964, KME21C3394, KME21D0029, KME21D0058, KME21D0186, KME21D0586, KME21D0648, KME21D0775, KME21D1103, KME21D1400, KME21D1423 g) 112082080, Lot Numbers: KME20J2998, KME20J3341, KME20K3520, KME20L0194, KME20L1157, KME20L1237, KME20L1706, KME20L2207, KME20L2333, KME20L2375, KME20L2607, KME20L2696, KME20M0577, KME20M1043, KME20M1069, KME20M1260, KME20M1342, KME20M1780, KME20M2363, KME21A0082, KME21A1435, KME21A1522, KME21A1524, KME21A2014, KME21A2058, KME21A2576, KME21B0049, KME21B0137, KME21B0248, KME21B0428, KME21B0616, KME21B0709, KME21B0863, KME21B1214, KME21B1284, KME21B2488, KME21B2489, KME21C0705, KME21C0706, KME21C1063, KME21C1325, KME21C1441, KME21C1745, KME21C1785, KME21C2068, KME21C3283, KME21C3320 h) 112082085, Lot Numbers: KME20J2999, KME20K0923, KME20K1114, KME20K1273, KME20K1513, KME20K3020, KME20K3034, KME20K3146, KME20L0670, KME20L0756, KME20L0757, KME20L1437, KME20L1549, KME20L1678, KME20L1707, KME20L1867, KME20L2274, KME20L2831, KME20M1511, KME20M1548, KME20M1849, KME20M3122, KME20M3248, KME21A0697, KME21A1093, KME21A2265, KME21A2577, KME21B0932, KME21B0958, KME21B1215, KME21C3024, KME21C3324, KME21D0061 i) 112082090, Lot Numbers: KME20K0180, KME20K0212, KME20K0600, KME20K0978, KME20K1434, KME20K3021, KME20K3525, KME20L0805, KME20L1142, KME21A2016, KME21A2676, KME21A3263, KME21B0632, KME21B1283 j) 112082095, Lot Numbers: KME20K1583, KME20K1831, KME20K2166, KME20K2574, KME20L1041, KME20L1592, KME20L2462, KME20L2557, KME20M2115, KME20M2198, KME21A2346, KME21A3264, KME21B1895, KME21C3326 k) 112082100, Lot Numbers: KME20K0977, KME20K1809, KME20K2553, KME20L0335, KME20M1341, KME20M2113, KME21A2342, KME21A2668, KME21C0017, KME21C0068, KME21D0827, KME21D1219
Recalling firm:
Teleflex Medical Europe Ltd
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UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2021

HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36

An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

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

Recall #:
88434
Lot/product code:
Lot Codes: U94Y9V U95C2A U94Z98 U95427 U9516E U95599 U9503G U95856 U94Y9W U95L0A U9518D U95526 U9507E U9548R U95127 U95525 U9530P U95T2Z U95366 U95R4F U9521Z U95F2T U9554U U95F8W U9564G U95U6A U95524 U95E6F U9512D U95K4D U94Z49 U95F07 U95A9X U95F6N U9569W U95E1U U9571P U95E72 U9587D U95E29 U95815 U95T90 U95814 U95Z67 U95754 U95Y7G U95D4T U9523L U95566 U9530X U9543R GTIN: 10705036015055
Recalling firm:
Ethicon Endo-Surgery Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2021

HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20

An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

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

Recall #:
88434
Lot/product code:
Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048
Recalling firm:
Ethicon Endo-Surgery Inc
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UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2021

Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000

If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient

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

Recall #:
88481
Lot/product code:
All Devices in distribution. UDI: 00732094309027 DDDYYKXXXXX DDD = 3 DIGIT JULIAN DAY (EXAMPLE - 234). YY = LAST 2 DIGITS OF JULIAN YEAR (EXAMPLE - 13) K = KEYTRONIC XXXXX = 5 DIGIT BASE 10 SERIALIZED NUMBER.
Recalling firm:
Welch Allyn Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 20, 2021

CritiCool, thermoregulation device

Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue.

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

Recall #:
90939
Lot/product code:
UDI-DI: 07290107581110 Serial Numbers: 9978580900011 99110698100043 99110698100044 9963715800012 9982077400003 9971040500004 9982294100006 9964294500006 9963715800008 9964294500007 9978580900008 9978580900009 9999186600019 99110008800035 99110008800036 99109321700020 99109321700026 99110992900020 99100663300011 99100663300014 99101637500005 99110698100048 9966227400007 9966227400012 9989990200008 9995915300007 9995915300014 9966227400008 9966227400011 9969231000003 9969231000004 9969231000005 9969570100004 9969570100014 9969570100018 99108208900030 99109321700010 9989990200012 99110992900011 9974072400005 99102316800013 9974085100011 9995355700003 99108208900023 99108208900025 996622740007 9969570100016 99104180900007 99107291500013 99107291500016 9983874900002 99108208900022 99109321700004 9978471200014 99100663300013 99100663300023 9995355500001 9995355500001 9995355500003 9995355500003 9996480200001 99104183000019 99104183000021 99110698100028 99110698100029 9982315400005 9982315400007 99110992900003 99110992900004 99110992900005 9964294500014 99102316800010 9999186600018 9999186600020 99100663300024 9974085100004 9989990200007 9995355500007 9974085100001 9974085100005 9974085100007 9974085100008 9974085100017 9974085100018 9974085100022 9974085100023 9974085100026 9975437700001 9969570200002 9969570100020 9976535500007 9976535500002 9986341600006 9986341600007 9986341600008 9975437700020 9981876000006 9981876000008 9982077400005 9982077400007 9982077400001 9995355600002 99110992900012 99110992900013 9995355500006 9986341600011 9988633600001 9988633600016 9973538600014 9978580900010 99104728800017 9964294500017 9976535500004 99100663300026 9964294500004 9969414800006 99109321700019 99108045000012 99108045000026 99108045000028 9973538500009 9974072400008 9982077400004 9982294100004 9982294100005 9999186600010 9999186600008 9971554000008 9971554000010 9982294100009 9963715800014 99110992900017 9969570200011 9971040400008 9971473300015 9982294100013 9975437700015 9976535500003 99110698100019 99110698100020 9963715800016 9964995000015 9975437700003 99108208900012 99100663300003 99104728800016 9966227400013 99104183000018 99104183000027 99110698100049 99110992900008 99110992900019 99103245000021 9969414800020 9964294500019 9986341600005 9995355500002 9999186600015 9991825100005 9991825100023 9992010100005 9992015300005 9992015300008 9996480200004 9995915300002 9995915300009 9966227400005 9966227400004 9969414800009 9969414800016 9969570100008 9969570100009 9969570100010 9969570100013 9971040400010 9971040500006 9971040500015 9971473300001 9971473300002 9971473300003 9971473300004 9971473300010 9971554000007 9973538500001 9973538500004 9973538500005 9973538500010 99110698100046 99110698100047 99110698100050 9969414800014 9973538600006 9976535500010 99110698100037 99108208900021 99101637500007 99102316800001 99101637500010 99102316800011 99104728800008 99104183000035 99104728000020 99104728800022 99104728800023 99104728800024 99104728800025 99104728800026 99110008800007 99110008800008 99110008800004 99110008800027 99108045000008 99109321700049 99109321700034 99110008800001 99110008800003 99110008800006 99109321700050 99110008800005 99109321700047 99109321700028 99109321700042 99109321700041 99109321700043 99109321700044 99110698100042 9974072400011 9974085100019 9995355700005 9995355700010 9995355700001 9995915300004 9995915300006 9995915300010 9995915300012 9995915300013 9996480200010 9996480200011 9996480200013 9996791600008 9996791600009 9996791600010 9999186600001 99104183000001 99104183000002 99104183000003 99104183000004 99104728800013 99104728800019 99104728800031 99107291500001 99107291500004 99110008800002 99110008800019 99110008800011 99110008800012 99110008800013 99110008800028 99110008800009 99110008800010 99110008800026 99110008800030 99109321700012 9971040500010 999535550001 999535550003 999535550004 999535550005 9.91016E+13 9.91042E+13 9.91047E+13 9.91082E+13 9.91082E+13 99110698100045 99110992900018 99110992900015 9954452900016 9961427900008 9969231000001 9969414800004 9969414800005 9969414800001 9977251300007 9977251300008 9977251300006 9977251300005 9977251300004 9977251300003 9964294500002 9966227400014 9969231000006 9969570200010 9969570200014 9979841600011 9978471200001 9978471200022 9981876000007 9988633600009 9989990200009 9992015300006 99102316800021 99104180900001 99110698100021 9993901400005 9979841600006 9979841600017 9970259900001 9969570200008 9971040400002 9971040400003 9973538500002 9973538500003 9973538500007 9979841600008 9978471200029 9981876000002 9981876000003 9981876000004 9982077400002 9983349200009 9983349200012 9983349300008 9983349300011 9983349300012 9983349300014 9986341500004 9983874900011 9986341500003 9986341500001 9996791600002 9996791600005 99100663300021 99100663300010 99100663300022 99100663300025 99101637500002 9910324500009 9910324500007 9910324500010 9910324500006 9910324500012 99107291500019 99107291500014 99107291500015 99107291500008 99108045000009 9910820… (truncated, 13802 characters total — see the official FDA record for the full value)
Recalling firm:
Belmont Instrument Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 20, 2021

Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030

Marketed without ANDA/NDA approval

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

Recall #:
D-0770-2021
Lot/product code:
all lots
Recalling firm:
HIS ENTERPRISE INC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 21, 2021

CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprofessionalsasdiagnosticsupportforpediatricandadultpatients.

Device failed to function as intended and/or failed to conform to their design specifications.

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

Recall #:
92206
Lot/product code:
CS 9600
Recalling firm:
Trophy SAS
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 22, 2021

EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi

Ultrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is positioning the monitor, or transporting/moving the system, which could lead to patient or user musculoskeletal injury.

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

Recall #:
88313
Lot/product code:
Manufactured Between 2020-02-27 to 2021-05-25
Recalling firm:
Philips Ultrasound Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 23, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

Potential for leaks and loosening at the patient catheter connection

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

Recall #:
88369
Lot/product code:
GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 23, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

Potential for leaks and loosening at the patient catheter connection

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▸Full report

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

Recall #:
88369
Lot/product code:
GTIN 05060116920253, Lot Numbers: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E
Recalling firm:
Boston Scientific Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

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

Recall #:
88333
Lot/product code:
Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Trilogy Evo Universal, Product number DS2000X11B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

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▸Full report

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

Recall #:
88333
Lot/product code:
Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
Recalling firm:
Philips Respironics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01

Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of "OK". In this scenario, the expired reagent will remain in the carousel for sample processing. 2) Performing monthly maintenance procedure 5701 Clean ICT Drain Tip incorrectly may potentially cause issues such as damaged connector or leaking connection. 3) A sample exception with message code 150 "Unable to process test. Previous processing module error" is produced without notifying the operator of a reagent pipettor failure and may cause processing module to transition into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results. 4. Reagent short dispense: Alinity c needs a control measure to protect against the potential for short reagent dispense. Addition of a maximum depth limit for reagent cartridges on the Alinity c to prevent the potential for a short dispense is needed. 5. RSM indicators were blinking green incorrectly: The Reagent and Sample Manager (RSM) indicators will incorrectly blink green indicating that processing is completed and the rack or cartridge can be removed from the loading area when the rack or cartridge should not be accessed. 6. Erroneous ICT Calibration Curves: Erroneous ICT calibration curves might be generated for the Alinity c when there is a malfunction of ICT reference solution delivery, use of wrong/evaporated calibrator, defective ICT modules, etc.

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

Recall #:
88502
Lot/product code:
Model Number: LN 03R70-01 all units with software versions 3.2.3 and earlier. Serial Numbers manufactured by Sanmina: SCM01001; SCM01002; SCM01003; SCM01004; SCM01005; SCM01006; SCM01007; SCM01008; SCM01009; SCM01010; SCM01011; SCM01012; SCM01013; SCM01014; SCM01015; SCM01016; SCM01017; SCM01018; SCM01019; SCM01020; SCM01021; SCM01022; SCM01023; SCM01024; SCM01025; SCM01026; SCM01027; SCM01028; SCM01029; SCM01030; SCM01031; SCM01032; SCM01033; SCM01034; SCM01035; SCM01036; SCM01037; SCM01038; SCM01039; SCM01040; SCM01041; SCM01042; SCM01043; SCM01044; SCM01045; SCM01046; SCM01047; SCM01048; SCM01049; SCM01050; SCM01051; SCM01052; SCM01053; SCM01054; SCM01055; SCM01056; SCM01057; SCM01058; SCM01059; SCM01060; SCM01061; SCM01062; SCM01063; SCM01064; SCM01065; SCM01066; SCM01067; SCM01068; SCM01069; SCM01070; SCM01071; SCM01072; SCM01073; SCM01074; SCM01075; SCM01076; SCM01077; SCM01078; SCM01079; SCM01080; SCM01081; SCM01082; SCM01083; SCM01084; SCM01085; SCM01086; SCM01087; SCM01088; SCM01089; SCM01090; SCM01091; SCM01092; SCM01093; SCM01094; SCM01095; SCM01096; SCM01097; SCM01098; SCM01099; SCM01100; SCM01101; SCM01102; SCM01103; SCM01104; SCM01105; SCM01106; SCM01107; SCM01108; SCM01109; SCM01110; SCM01112; SCM01113; SCM01114; SCM01115; SCM01116; SCM01117; SCM01118; SCM01119; SCM01120; SCM01121; SCM01122; SCM01123; SCM01124; SCM01125; SCM01126; SCM01127; SCM01128; SCM01129; SCM01130; SCM01131; SCM01132; SCM01133; SCM01134; SCM01135; SCM01136; SCM01137; SCM01138; SCM01139; SCM01140; SCM01141; SCM01142; SCM01143; SCM01144; SCM01145; SCM01146; SCM01147; SCM01148; SCM01149; SCM01150; SCM01151; SCM01152; SCM01153; SCM01154; SCM01155; SCM01156; SCM01157; SCM01158; SCM01159; SCM01160; SCM01161; SCM01162; SCM01163; SCM01164; SCM01165; SCM01166; SCM01167; SCM01168; SCM01169; SCM01170; SCM01171; SCM01172; SCM01173; SCM01174; SCM01175; SCM01176; SCM01177; SCM01178; SCM01179; SCM01180; SCM01181; SCM01182; SCM01183; SCM01184; SCM01185; SCM01186; SCM01187; SCM01188; SCM01189; SCM01190; SCM01191; SCM01192; SCM01193; SCM01194; SCM01195; SCM01196; SCM01197; SCM01198; SCM01199; SCM01200; SCM01201; SCM01202; SCM01203; SCM01204; SCM01205; SCM01206; SCM01207; SCM01208; SCM01209; SCM01210; SCM01211; SCM01212; SCM01213; SCM01214; SCM01215; SCM01216; SCM01217; SCM01218; SCM01219; SCM01220; SCM01221; SCM01222; SCM01223; SCM01224; SCM01225; SCM01226; SCM01227; SCM01228; SCM01229; SCM01230; SCM01231; SCM01232; SCM01234; SCM01235; SCM01236; SCM01237; SCM01238; SCM01239; SCM01240; SCM01241; SCM01242; SCM01243; SCM01244; SCM01245; SCM01246; SCM01247; SCM01248; SCM01249; SCM01250; SCM01251; SCM01252; SCM01253; SCM01254; SCM01255; SCM01256; SCM01257; SCM01258; SCM01259; SCM01260; SCM01261; SCM01262; SCM01263; SCM01264; SCM01265; SCM01266; SCM01267; SCM01268; SCM01269; SCM01270; SCM01271; SCM01272; SCM01273; SCM01274; SCM01275; SCM01276; SCM01277; SCM01278; SCM01279; SCM01280; SCM01281; SCM01282; SCM01283; SCM01284; SCM01285; SCM01286; SCM01287; SCM01288; SCM01289; SCM01290; SCM01291; SCM01292; SCM01293; SCM01294; SCM01295; SCM01296; SCM01297; SCM01298; SCM01299; SCM01300; SCM01301; SCM01302; SCM01303; SCM01304; SCM01305; SCM01306; SCM01307; SCM01308; SCM01309; SCM01310; SCM01311; SCM01312; SCM01313; SCM01314; SCM01315; SCM01316; SCM01317; SCM01318; SCM01319; SCM01320; SCM01321; SCM01322; SCM01323; SCM01324; SCM01325; SCM01326; SCM01327; SCM01328; SCM01329; SCM01330; SCM01331; SCM01332; SCM01333; SCM01334; SCM01335; SCM01336; SCM01337; SCM01338; SCM01339; SCM01340; SCM01341; SCM01342; SCM01343; SCM01344; SCM01345; SCM01346; SCM01347; SCM01348; SCM01349; SCM01350; SCM01351; SCM01352; SCM01353; SCM01354; SCM01355; SCM01356; SCM01357; SCM01358; SCM01359; SCM01360; SCM01361; SCM01362; SCM01363; SCM01364; SCM01365; SCM01366; SCM01367; SCM01368; SCM01369; SCM01370; SCM01371; SCM01372; SCM01373; SCM01374; SCM01375; SCM01376; SCM01377; SCM01378; SCM01379; SCM01380; SCM01381; SCM01382; SCM01383; SCM01384; SCM01385; SCM01386; SCM01387; SCM01388; SCM01389; SCM01390; SCM01391; SCM01392; SCM01393; SCM01394; SCM01395; SCM01396; SCM01397; SCM01399; SCM01400; SCM01401; SCM01402; SCM01403; SCM01404; SCM01405; SCM01406; SCM01407; SCM01408; SCM01409; SCM01410; SCM01411; SCM01412; SCM01413; SCM01414; SCM01415; SCM01416; SCM01417; SCM01418; SCM01419; SCM01420; SCM01421; SCM01422; SCM01423; SCM01424; SCM01425; SCM01426; SCM01427; SCM01428; SCM01429; SCM01430; SCM01431; SCM01432; SCM01433; SCM01434; SCM01435; SCM01436; SCM01437; SCM01438; SCM01439; SCM01440; SCM01441; SCM01442; SCM01443; SCM01444; SCM01445; SCM01446; SCM01447; SCM01448; SCM01449; SCM01450; SCM01451; SCM01452; SCM01453; SCM01454; SCM01455; SCM01456; SCM01457; SCM01458; SCM01459; SCM01460; SCM01461; SCM01462; SCM01463; SCM01464; SCM01465; SCM01466; SCM01467; SCM01468; SCM01469; SCM01470; SCM01471; SCM01472; SCM01473; SCM01474; SCM01475; SCM01476; SCM01477; SCM01478; SCM01479; SCM01480; SCM01481; SCM01482; SCM01483; SCM01484; SCM01485; SCM01486; SCM01487; SCM01488; SCM01489; SCM01490; SCM01491… (truncated, 53936 characters total — see the official FDA record for the full value)
Recalling firm:
Abbott Laboratories
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UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).

ALL 50 STATES
▸Full report

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

Recall #:
88333
Lot/product code:
Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
Recalling firm:
Philips Respironics, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled July 26, 2021

Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10

If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.

IANJNYPATNTXWI
▸Full report

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

Recall #:
88451
Lot/product code:
Software Builds: 5.40.00, 5.40.01, 5.40.02, 5.51.10 UDI: (01)00858164002190(10) 5.40.00 (01)00858164002190(10) 5.40.01 (01)00858164002190(10) 5.40.02 (01)00858164002268(10) 5.51.10
Recalling firm:
Elekta Inc
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