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Recalls affecting Mississippi

Data last updated: September 8, 2026 at 1:13 PM UTC

16,726 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 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/virusAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

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Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

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Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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UnclassifiedBacteria/virusAnnounced 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)
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)
UnclassifiedAllergenUndeclaredAnnounced 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)
UnclassifiedBacteria/virusAnnounced 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/virusAnnounced 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)
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Wording
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2019

The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.

Lack of 510K clearance

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▸Full report

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

Recall #:
83298
Lot/product code:
ALL
Recalling firm:
Opternative Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2019

Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.

Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.

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▸Full report

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

Recall #:
85091
Lot/product code:
Model Number CSS7200 (Guardian Connect App: iOS); Catalog Numbers: MMT-7821 (Guardian Connect Transmitter - GST4C); UPN - 00763000186333.  There are no assigned lot or serial numbers.
Recalling firm:
Medtronic Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2019

LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector USB, Model Number H41212RR; f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC Product Usage: Vscan Extend is a general- purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It s pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage.

Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.

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

Recall #:
82938
Lot/product code:
a. Model Number H41212ZA, Serial Number (UDI): VH162494DA (01008406821216511118060021VH162494DA), VH162530R2 (01008406821216511118060021VH162530R2), VH160454PQ (01008406821216511118040021VH160454PQ), VH161212Z9 (01008406821216511118040021VH161212Z9), VH162305WM (Not Available), VH162300UE (Not Available), VH163166GF (Not Available), VH163170QD (Not Available), VH162011PE (01008406821216511118040021VH162011PE), VH163454AQ (01008406821216511118110021VH163454AQ), VH161912X9 (01008406821216511118040021VH161912X9), VH163489ED (01008406821216511118110021VH163489ED), VH160832WB (01008406821216511118040021VH160832WB), VH162896FQ (01008406821216511118100021VH162896FQ), VH163307IQ (Not Available), VH160748G4 (01008406821216511118040021VH160748G4), VH163100A6 (Not Available), VH162900GC (Not Available), VH163879G6 (Not Available), VH163278ZM (Not Available), VH162142TV (Not Available), VH163485KC (Not Available), VH163031AZ (Not Available), VH163175AT (Not Available), VH162126EN (Not Available), VH163659A8 (Not Available), VH1633048M (Not Available), VH163350EC (Not Available), VH163326UE (Not Available), VH163770L1 (Not Available), VH163784LD (Not Available), VH163036JA (Not Available), VH161216M7 (Not Available), VH1620432N (01008406821216511118040021VH1620432N), H41212RN, Serial Number (UDI): VH160254IY (Not Available), VH1607044U (Not Available), VH160176N2 (Not Available), VH1600406Z (Not Available), VH160053C5 (01008406821216511117020121VH160053C5), VH160485GP (Not Available), VH160181WQ (Not Available), VH161330TM (Not Available), VH160164PH (Not Available), VH16055084 (Not Available);   b .Model Number H41212RK, Serial Number (UDI): VH160462WV (Not Available), VH16092049 (Not Available);   c. Model Numbers H41212YZ, Serial Number (UDI): VH163439U9 (Not Available), VH163527ZC (Not Available), VH163066UJ (Not Available), VH163340NW (Not Available), VH163458CU (Not Available), VH163502LY (Not Available), VH163511T8 (Not Available), VH1636016Y (Not Available), VH163755YI (Not Available), VH163691TX (Not Available), VH1637399H (Not Available), VH163746S1 (Not Available), VH163764NN (Not Available), VH163763GE (Not Available), VH163759LP (Not Available), VH163765G2 (Not Available), VH163116N7 (Not Available), VH163044T8 (Not Available), VH162988WW (Not Available), VH163374LA (Not Available), VH163398MZ (Not Available), VH163428UW (Not Available), VH163415KB (Not Available), VH163446Z5 (Not Available), VH1634671E (Not Available), VH1636924B (Not Available), VH163744SF (Not Available), VH1637439Z (Not Available), VH1637388B (Not Available), VH163747I4 (Not Available), VH163741W3 (Not Available), VH163761IM (Not Available), VH16374052 (Not Available), VH163762TT (Not Available), VH163756TX (Not Available), VH1637451Y (Not Available), VH163766TJ (Not Available), VH163461K7 (Not Available), VH1634367P (Not Available), VH163383YB (Not Available), VH163493AE (Not Available), VH163477CV (Not Available), VH163445UT (Not Available), VH163676PS (Not Available), VH163671M1 (Not Available), VH1636685E (Not Available), VH163672YP (Not Available), VH1617429V (Not Available), VH163373TQ (Not Available), VH1634495A (Not Available), VH162698PH (Not Available), VH163113IV (Not Available), VH1633366P (Not Available), VH163002F8 (Not Available), VH163093EU (Not Available), VH16313978 (Not Available), VH163450F7 (Not Available), VH163751QX (Not Available), VH1632313N (Not Available), VH163748WX (Not Available), VH163754PU (Not Available), VH163742K9 (Not Available), VH1631245M (Not Available), VH162779KK (Not Available), H41212RL, Serial Number (UDI): VH1600189D (Not Available), VH1606843M (Not Available), VH1604606U (Not Available);   d. Model Number H41212ZD, Serial Number (UDI): VH1505638R (Not Available), VH150582C6 (Not Available), VH150663J5 (Not Available), VH150553A2 (Not Available);   e. Model Number H41212RR, Serial Number (UDI): VH150282CY (Not Available);   f. Model Number H41212ZC, Serial Number (UDI): VH150657SF (Not Available)
Recalling firm:
GE Healthcare, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2019

The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.

Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line

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

Recall #:
88162
Lot/product code:
Lot Number: 2000401997  Unique Device Identifier (UDI) 08717872021294
Recalling firm:
Dutch Ophthalmic USA, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 23, 2019

Various products which were contract sterilized.

The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.

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

Recall #:
83001
Lot/product code:
Product Number (Lot Code):   1. G26862 (W3915653);   2. 8065751801 (15027297X-2015-06);   3. E7924 (HD1206703);   4. MCFK64 (MBKY190);   5. PCB502090 (16105672, 17525844);   6. PCB602090 (17766962, 17716501, 17505067, 17465154, 17339717, 17191941, 16536005, 15473410, 15441264, 16685888);   7. PCB702090 (16722293);   8. 277-10-50 (12094017);   9. 420024 (73B1500332);   10. 160636 (1202143, 1109213),   11. 160656 (1208163);   12. 7210424 (50506601);   13. AD750-KE40 (169-16), AD750-KE35 (182-16);   14. AD750-KE30 (102-16);   15. AD750-KE35 ( 118-16);   16. 614-481 (648221);   17. 76353200M (208992282, 207180152, 206969148, 206110579);   18. ASHA4250-01 (2004847);   19. GN1000 (9592565);   20. GN1500 (9916746);   21. SK200 (9577286);   22. GN2000 (9909194);   23. 9-AVP2-014 (1204040241);   24. 9-AVP2-016 (1201055704);   25. 401814RMC (35227834);   26. EICA5872-01 (1035512, 1049334, 1046764, 1050636);   27. 1011895H (141110A081);   28. 10031 (AM043619);   29. 424-7020W (17022849);   30. 424-5020W (17144227);   31. 115321 (HUUG0824), 115311 (HUTJ0689);   32. 96830-012 (12071254);   33. 96880-021 (2016120999);   34. OMS-T10BT ( P6J0204X, P6M0586X, P6H0631X);   35. 113230 (HUZH2232, HUZF1409, HUZI1854);   36. 681 (HUWB1603 );   37. S11886001 (HUWB1085);   38. G09691 (5335591);   39. G27023 (5094825);   40. G11672 (5425109, 5201291);   41. KD-V431M-0720 (73V, 72V, 76V);   42. KD-V411M-0730 (71V, 6ZV);   43. 8065750352 (1642344H);   44. 260-120 (15603764);   45. G53025 (4414833);   46. 82-1735 (CNCDBF);   47. 134450 (HUWA0947, HUVJ0726, HUVA1707);   48. CQF7554 (REYF0349);   49. CS40G (F4PE3M, F4PF8T);   50. M00530880 (G65382, G43088);   51. M00530870 (3888336, 788930, G43096, G59523);   52. G22732 (W3627617, W3665361, W353500, W3655212, W3531994);   53. G21765 (W3775367, W3611934);   54. 2124 (MN14080, MN13391);   55. 2296-100-216 (12034017);   56. PCB802090 (17747960);   57. 112750 (HUVJ1411, HUVF1668, HUUJ1326, HUTG1189, HUTE0455, HUSL1081);   58. 70138014 (531003018);   59. 70138001 (619552823);   60. 70138033 (640797753);   61. D-201-12704 (46K);   62. 24009 (2014011549);   63. G25671 (C1305047, C1314474, C1320703);   64. G25672 (C1162486, C1160026);   65. 5614 (20249064);   66. 91-12504 (6000004655);   67. SRK30 (MO27683);   68. 105-5092-150 (A096597);   69. ECR60W (L4EE9G, J4AE6D, K4DP4M, K4CC4H);   70. EC45A (K4CZ96);   71. EGIA45AMT (N2E0120ULX);   72. 30453 (N9L0087);   73. 30453 (N9A14);   74. 30453 (N2F0101LX);   75. 30453 (N2B0429LX);   76. 30453 (N1L0731LX);   77. 30453 (N1H0786LX);   78. 30453 (N1H0728LX);   79. 30453 (N5E0943KX);   80. 30453 (N1H0296LX);   81. 30453 (N1G0663LX);   82. 30453 (N1F0631LX);   83. 30453 (N0L0261);   84. 30453 (N0K0525);   85. 30453 (N1C0147LX);   86. 30453 (N3C0249LX);   87. 30453 (N2K0152LX);   88. 30453 (N2J0639LX);   89. 30453 (N4L0080KX);   90. 30453 (N2B0265LX);   91. 30453 (N1M0234LX);   92. 30453 (N1H0494LX);   93. 30453 (N1D0605LX);   94. 30453 (N9G0020);   95. 30453 (N8C413);   96. 30453 (N3F0179LX);   97. 30453 (N3B0327LX);   98. 30453 (N2F0340LX);   99. 30453 (N3E0189LX);   100. 30453 (N2C0297LX);   101. 30453 (N1L0474LX);   102. 30453 (N1G0249LX);   103. 30453 (N3D0092LX);   104. 30453 (N2F0194LX);   105. 30453 (N1F0422LX);   106. 30453 (N0F0164);   107. 30453 (N2B0529LX);   108. 30453 (N1F0767LX);   109. 173016 (N2F0618X);   110. 174601 (P2J0627X);   111. 30453 (N3C0405LX);   112. 30453 (N3A0707LX);   113. 30453 (N3A0221LX);   114. 30453 (N2K0401LX);   115. 30453 (N2G0538LX);   116. 30453 (N1M0112LX);   117. 30453 (N1H0900LX);   118. ECS33A (J4AT7Z, J4AG4G);   119. VH-3200 (25126202);   120. M00582080 (925804);   121. 711145 (1412697);   122. ATS45 (K4C81P);   123. 168190 (18673916);   124. 1000-90 (ELV32219V, ELV32215V);   125. G12830 (5204864);   126. OMS-XB2 (P6E0652X);   127. 3932 (20769076);   128. G11638 (5138842);   129. G30393 (U2102887, U2018952);   130. CBM320010 (16933371);   131. CBM325010 (15280044);   132. CBM325006 (13530853);   133. CBM330006 (16816611);   134. CBM340010 (17078794);   135. CBM340006 (EH5796);   136. 375-940-000 (12117CE2);   137. G49572 (W3357124, W3908339, W3816378);   138. G48277 (W3905583, W3915008, W3989699);   139. G48278 (W3852820, W3835461, W3856129, W3849232, W3864789);   140. G50977 (W3797199, W3771825, W3763156);   141. G31527 (C1287719, C1212820);   142. G31551 (C1384600);   143. G21613 (W3621261, W3746570, W3920476);   144. G21475 (C1103316, C1136032), G21478 (C1222618, C1264137), G21479 (C1291590, C1231802, C1231802, G21480 (C1176271, C1215997, 1404674, C1406615);   145. G21578 (C1168847, C1193440, G21578 (C1349288);   146. G22190 (C1133441, C1181667);   147. G22206 (C1303007, C1151429);   148. G22212 (C1226620, G22212 (C1333128);   149. G22209 (C1159612, C1195005, C1401555);   150. G22210 (C1263370, C1137419, C1398095);   151. G21575 (C1181665, C1264138, C1269765)… (truncated, 13277 characters total — see the official FDA record for the full value)
Recalling firm:
Anewmed Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 23, 2019

Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.

During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.

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

Recall #:
85050
Lot/product code:
ObalonR Balloon System with Navigation and Touch. UDI: 00859810006104; Model No.: Model 4300 Touch Dispenser;Software version 02.00.00.0076. Serial Numbers: 0097, 0076, 0077, 0078, 0079, 0080, 0082, 0083, 0084, 0085, 0086, 0087 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0097, 0099, 0100, 0101, 0102, 0103, 0104, 0106, 0107, 0109, 0111, 0112, 0113, 0115, 0118, 0119, 0120, 0121, 0122, 0125, 0126, 0127, 0129, 0130, 0133.
Recalling firm:
Obalon Therapeutics Inc
View official FDA record (opens in a new tab)
Class IHigh risk
FoodUndeclaredRecalled May 27, 2019

"DEEP***GOLDEN RAISINS***NET WT***198g/7oz***DEEP FOODS, INC. UNION, NJ 07083"

Deep Foods Inc., 1090 Springfield Road, Union, NJ-07083 is initiating a recall of Deep Golden Raisins because of not listed on the label sulfites.

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

Recall #:
F-1981-2019
Lot/product code:
This recall covers 7oz, 14oz, and 28oz sizes with the following UPC codes: 7oz: 011433133432 14oz: 011433133449 28oz: 011433433457
Recalling firm:
Deep Foods Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 30, 2019

Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LAPAROSCOPY PACK-LF, LAPAROSCOPY PELVISCOPY PACK, LAP ABDOMINAL CDS-LF, GENERAL LAPAROSCOPY CDS, GYN LAPAROSCOPY CDS, CSMC/ENDOSINUS/NASAL PACK-LF, GENERAL LAPAROSCOPY PACK, GENERAL SURGERY, MODULE TONSIL, MODULE GYN LAP NATALIE, GEN SURGERY LAP CHOLE PACK, T & A CDS, GYN LAPAROSCOPY PACK, GENERAL LAPAROSCOPY, GYN LAPAROSCOPY, TONSIL PACK, LAPAROSCOPY CDS-LF, TRMC GENERAL ENDOSCOPY PACK, GENERAL ENDOSCOPIC PACK-LF, RVMC LAP CHOLE PACK, LAP CHOLE PACK, MH GENERAL LAPAROSCOPY, THORACIC, GB GENERAL ENDO, T & A, DM LAPAROSCOPY PACK, THORACIC ROBOT, LAVH PACK, LAPAROSCOPY, T AND A, SINUS PACK, ROBOTICS PACK-LF, GYN LAPAROSCOPY-LF, LAPAROSCOPIC PACK, GENERAL LAP PACK, ENT PACK, OPEN HEART PK A&B&C, LAPAROSCOPIC, LAP TUBAL LIGATION PACK, ROBOTICS SI, OPEN HEART CDS, LAPAROSCOPY CDS, LAP GASTRIC BY PASS, GENERAL LAPAROSCOPY PK-LF, THORACOTOMY THORACOSCOPY, T AND A COBLATOR, ROBOTICS PACK, TOTAL LAP HYSTERECTOMY CDS, LAPAROSCOPY TRAY-LF, PATEWOOD T AND A PACK, FESS PACK, AMB MSL W INJECTION, LAP CHOLE CDS, NASAL SEPTOPLASTY PACK, ENDOSCOPY PACK, AMB GYN LAPAROSCOPY, GASTRIC BYPASS CDS-LF, MHC LAP CHOLE, HHOR ENT, LAP BARIATRIC, LAPAROSCOPY PACK, MHC OPEN HEART 1 OF 2, BARIATRIC, GENERAL LAP PACK-LF, MAG LAPAROSCOPY CDS, SPRINGHILL LAP CHOLE PACK, BMHM GASTRIC BAND-BYPASS PACK, NASAL PACK, LAPAROSCOPY PACK - OSC, ALT GENERAL LAPAROSCOPY CDS, MER ROBOTIC, JAM/HRZ GENERAL LAPAROSCOPY, ARTHROSCOPY PACK, MAJOR LITHOTOMY SOMC-LF, BARI GASTRECTOMY CDS, LAP GYN PACK-LF, THORACOTOMY PACK-LF, T&A PACK-LF, PELVISCOPY PACK, GENERAL LAPAROSCOPY-LF, ROBOT GYN, MAJOR ENT PACK, TONSIL & ADENOIDS PACK, PROSTATE ROBOTIC, CARDIAC SURGERY CABG PACK-LF, LAP CHOLE TRAY, THORASCOPIC TETHERING OR PACK, ROBOTIC PACK, LAVH, OPEN HEART, LAP CHOLE QVH VER. B, BARIATRIC-LF, T&A TRAY #64-RF, BASIC LAP PACK W TUBING, TONSIL & ADENOID PACK, CUSTOM ENDOSCOPY PACK-LF, FESS TRAY #60-RF, LAP PACK WITHOUT TUBING, NASAL SINUS ENDOSCOPY, DAVINCI, TV LAP PACK-LF, MAD T & A, ROBOTIC GU/GYN, RICH LAVH, GYN ROBOTIC-LF, MAD GYN LAPAROSCOPY, PAD GYN LAPAROSCOPY, OSC GYN LAP, SUB GYN LAPAROSCOPY PACK-LF, LAPAROSCOPY-ROBOT, GYN LAP KIT, GENERAL LAP, LAP CHOLE PACK B10, LAP CHOLE CDS-LF, GYN LAPAROSCOPY PACK-LF, LAP CHOLE SURGICOUNT, DIAGNOSTIC LAP PACK, CABG-VEIN HARVESTING PACK-LF, TONSIL PACK UOPSC-LF, BELLEVUE T&A PACK, BGH 001471 SHOULDER PACK-LF, SCOPE LAP THOR PACK, MAIN/LAPAROSCOPY GYN PACK-LF, LAP CHOLE OR PACK, ENSEMBLE THORACO-LF, LAPAROSCOPIE CHIRURGICALE-LF, MAJOR GYN LAPAROSCOPY CDS, HEPATOBILIAIRE LAPAROSCOPIE-LF, GYNE MAJOR LAPAROSCOPY GRH-LF, LAP CHOLE PACK TBRHSC-LF, MAJOR LAPAROSCOPIC SJHC-LF, LAPAROSCOPY RVHS-LF, LAPAROSCOPY III-LF.

The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.

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

Recall #:
83000
Lot/product code:
Fog solution Component Number: 80532/NONFB100B, Material Lot Number: 41186649M, 41186673M, 41211955M, 41186657M, 41236925M, 41186665M, 41102767M. Expiration Date 12/2020.   Impacted Kit Number (Lot Number): DYNJ902840B (19CBW843), DYNJ904625B (19CBA697), DYNJ42835A (19CBA118), DYNJ39685A (19BBH495), DYNJ32935C (19BBE174), DYNJ36418F (19ABN461), DYNJ50765B (19BBJ183), DYNJ47704C (19BBE810), DYNJ0862775N (19CBA813), DYNJ43628A (19BBG651), CDS984674C (19CBA033), CDS984659K (19BBT877), CDS984656L (19ABO984), DYNJ0665310C (19CBG762), DYNJ42547B (19BBI339), DYNJ903659B (19BBT906), DYNJ903040C (19BBS351), DYNJ903038C (19CBB639), DYNJ54065 (19BBJ372), DYNJ900363G (19ABL752), DYNJ57609 (19ABN755), DYNJ903321J (19CBF179), DYNJ900357K (19BBU012), DYNJ904588 (19BBT976), CDS920126Y (19ABI371), DYNJ59847 (19ABN404), DYNJ22661K (19BBF049), DYNJ33545G (19ABI674), DYNJ26209L (19BBG751), DYNJ49882F (19ABN534), DYNJ903014C (19BBU011), CDS984155D (19BBD541), DYNJ904638A (19ABZ742), DYNJ59546 (19ABM642), DYNJ903012B (19ABI127), DYNJ43439B (19BBG181), DYNJ904605B (19ABX225), DYNJ902777C (19BBU748), DYNJ45036C (19BBH070), DYNJ0457880B (19BBD190), CDS760059F (19CBS256), DYNJ52677G (19ABM568), DYNJ37208B (19ABN372), DYNJ57108 (19BBH759), DYNJ27981L (19BBU534), DYNJ22708C (19CBI729), DYNJ42513B (19BBC527), DYNJ902659D (19DBC026), CDS984368A (19CBS618), CDS985100G (19BBU591), DYNJ902881A (19BBU615), DYNJ36733B (19BBT315), DYNJ902882B (19BBQ157), DYNJ56866A (19BBJ416), DYNJ43971 (19ABO971), CDS983055I (19BBD510), DYNJ24254D (19ABE952), DYNJ51727A (19BBJ776), DYNJ43160 (19BBE200), DYNJ59927 (19ABM565), CDS985356F (19CBH288), DYNJ50960D (19BBG937), DYNJ50594B (19BBC092), DYNJ59925 (19ABI682), CDS983771F (19BBS841), DYNJ903722F (19CBC482), DYNJ903688D (19BBN377), DYNJ901777M (19CBB415), DYNJ56696A (19BBT371), DYNJ904790B (19CBC724), DYNJ904826 (19BBA006), PHS628590008A (19BBG657), CDS982906K (19CBE109), DYNJ40736D (19ABE199), DYNJ32364F (19BBO433), DYNJ56626A (19BBI464), DYNJ43573A (19BBE169), CDS983900G (19CBE065), DYNJ901430F (19CBV052), DYNJ900760J (19CBA299), DYNJ36365B (19BBB942), DYNJ901160D (19ABH656), CDS860237V (19CBL702), DYNJ0618440D (19ABH894), DYNJ50543A (19ABI681), DYNJ0798129F (19BBD878), DYNJ31754C (19BBT585), DYNJ900723A (19DBF086), DYNJ900299D (19CBB300), DYNJ45576A (19BBU372), DYNJ53270B (19BBT500), DYNJ901822 (19BBA013), DYNJ24608F (19BBQ880), DYNJ41082F (19ABN865), DYNJ51144A (19ABM266), DYNJ50474B (19ABM212), DYNJ900298F (19CBD978), CDS981161W (19CBC564), DYNJ903906B (19CBM352), DYNJ904214A (19CBB908), DYNJ27440R (19BBG783), DYNJ57093 (19ABM639), DYNJ43427C (19ABM274), DYNJ55478B (19BBS313), DYNJ27430P (19BBE005), DYNJ53718A (19BBG277), DYNJ54690A (19BBC770), DYNJ901076F (19BBU036), DYNJ41531F (19BBJ347), DYNJ902165C (19BBR800), CDS983393I (19CBF160), DYNJ902188G (19ABY723), DYNJ903000D (19BBP501), DYNJ902172C (19ABL727), DYNJ902136F (19CBD684), DYNJ901868B (19BBU852), DYNJ30799D (19ABN506), DYNJ905003A (19CBK506), DYNJ56110 (19BBR129), DYNJ52016 (19BBU234), DYNJ57571 (19CBA099), CDS982234F (19ABZ502), DYNJ01910I (19ABU373), DYNJ45531C (19BBD198), DYNJ40156B (19CBA412), DYNJ20431K (19BBI165), DYNJ39810B (19ABI411), DYNJ35833C (19BBG604), DYNJ0705925D (19BBJ785), DYNJ00210K (19BBG066), DYNJ0567019U (19ABN489), DYNJ42420A (19ABO947), DYNJ48752A (19BBQ917), DYNJ58542A (19BBT963), CDS984007B (19BBR816), DYNJ47554B (19ABN648), DYNJ41789C (19ABN541), DYNJ41939A (19BBG785), DYNJ900787C (19CBS603), DYNJ46864 (19BBU487), DYNJS3024 (19ABL847), DYNJQ9044M (19BBS346), DYNJ33112G (19BBS717), DYNJ901674F (19BBS864), CDS984659K (19CBI752), DYNJ57609 (19CBA524), DYNJ905095 (19BBF351), DYNJ40064I (19BBF021), DYNJ905797 (19ABZ654), CDS981512D (19CBL323), DYNJ53067C (19ABA014), CDS985242D (19BBT180), DYNJ901501C (19BBI586), DYNJ901501C (19BBU616), DYNJ37208B (19BBG261), DYNJ60647 (19ABN834), DYNJ48601 (19BBG158), DYNJ57623 (19BBG755), DYNJ50746 (19ABM536), DYNJ48599 (19BBG561), DYNJ903514B (19CBA001), CDS983055I (19CBL202), DYNJ24254D (19CBA271), DYNJ50958C (19BBE201), DYNJQ0589J (19ABI633), DYNJQ0589J (19BBG274), DYNJ30954 (19ABR748), DYNJ33197G (19ABH728), DYNJ33197G (19BBI455), DYNJ902830B (19BBS834), DYNJ53409 (19BBI406), DYNJ53409 (18MB7934), DYNJ46488C (19BBC858), DYNJ56036A (19BBG377), DYNJ902250C (19BBS839), DYNJ904826 (19BBN793), DYNJ904826 (19BBR431), CDS982906K (19CBI565), DYNJ902546G (19ABX896), DYNJ48431B (19ABJ347), DYNJ901210D (19CBK476), DYNJ901210D (19EBB837), DYNJ30988C (19ABN378), DYNJ30988C (19BBT617), DYNJ41365D (19BBG190), DYNJ39406A (19ABN416), DYNJ56004 (19CBA327), DYNJ901160D (19BBS792), DYNJ50052A (19BBJ218), DYNJ60067 (19BBG907), DYNJ903254A (19BBD540), DYNJ903254A (19CBG054), CDS981537D (19CBA526), DYNJ49351 (19BBJ114), DYNJ40981F (19BBG606), DYNJ43869I (19ABE918), DYNJ33189 (19BBE839), DYNJ46962F (19CBA778), DYNJ53650B (19ABJ753), DYNJ02309C (19BBG760), DYNJ49558B (19BBB744), DYNJ39666D (19BBI360), DYNJ55323B (19BBQ851), DYNJ901330C (19ABX749), DYNJ51195C (19ABM930), DYNJ41630B (19BBG910), CDS984769D (19… (truncated, 5605 characters total — see the official FDA record for the full value)
Recalling firm:
Medline Industries, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 31, 2019

CLEO Patient Monitor /Tranquility VS Patient Monitor

The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.

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

Recall #:
82999
Lot/product code:
Serial Numbers - A18094501812, A18014501391, A18014600053, A18014600070, A18014600080, A18014501432, A18014501438, A17074501202, A17084501263, A17024500996, A16054500521, 45000082, 45000084, 45000085, 45000057,45000058, A1 8094501659, A17044501052, A17024500972, A160104500653, A160104500674, A160104500685, A160104500701, A16084500604, A16084500605, A15104500320, A15 104500407, A15104500257, 45000083, 45000043, 45000044, 45000045, A17024500996, A18094501642, A18094501674, A18094501696, A17074501227, 45000072, 48000001, 48000002, 48000003, A1 8094501639, A18094501652, A18094501657, A18094501702, A18094501719, A18044600082, A18044600083, A18044600087, A18044600089, A18044600092, A17124501378, A17124501384, A17124501385, A17124501386, A17124501387, A17024800002, A17024800004, A17024800006, A17024800007, A17024800008, A17024800012, A17024800013, A17024800018, A17024800021, A17024800022, A17024800024, A17024800028, A17024800030, A1702480003 1, A17024800032, A17024800039, A17024800043, A17024800046, A17024800048, A17024800050, A17024800009, A17024800014, A17024800015, A17024800016, A17024800017, A17024800019, A17024800020, A17024800025, A17024800026, A17024800027, A17024800029, A17024800033, A17024800034, A17024800037, A17024800038, A17024800040, A17024800042, A17024800044, A17024800047, A17024800049.
Recalling firm:
Infinium Medical, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 6, 2019

LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

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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-1456-2019
Lot/product code:
Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 6, 2019

LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

ALL 50 STATES
▸Full report

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

Recall #:
D-1455-2019
Lot/product code:
Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020
Recalling firm:
Teva Pharmaceuticals USA
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 12, 2019

ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a metronome designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of at least 2 inches (5 cm) for adult patients. The AED PRO system is indicated for use on victims of cardiac arrest with apparent lack of circulation as indicated by: Unconsciousness Absence of breathing, and Absence of pulse and other signs of circulation. The device is also indicated for use when ECG monitoring is indicated to evaluate the patient s heart rate or ECG morphology. The AED PRO system is indicated for adult and pediatric patients.

There is a potential for the device to fail to deliver energy to the patient.

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

Recall #:
83109
Lot/product code:
Part Numbers: 90010200499991010,  90010400499991010,  70010400499991010,  90010202499991010,  90010600499991010;   GTIN: 00847946016128,  00847946016142,  00847946015138,  00847946016135,  00847946016166  Serial Numbers: AA17C041915 AA17C041916 AA17J043664 AA17J043666 AA17J043670 AA17J043671 AA17J043672 AA17J043673 AA17J043674 AA17J043675 AA17J043682 AA17J043683 AA17J043725 AA17J043813 AA17J043814 AA17J043817 AA17J043820 AA17J043825 AA17L044265 AA18B044867 AA18B044868 AA18B044869 AA18B044870 AA18B044871 AA18B044872 AA18B044873 AA18B044874 AA18B044875 AA18B044877 AA18B044878 AA18B044879 AA18B044880 AA18B044881 AA18B044882 AA18B044883 AA18B044884 AA18B044885 AA18B044886 AA18C044887 AA18C044888 AA18C044889 AA18C044890 AA18C044891 AA18C044892 AA18C044893 AA18C044894 AA18C044895 AA18C044896 AA18C044897 AA18C044898 AA18C044899 AA18C044900 AA18C044901 AA18C044902 AA18C044903 AA18C044904 AA18C044905 AA18C044906 AA18C044907 AA18C044908 AA18C044909 AA18C044910 AA18C044911 AA18C045011 AA18C045012 AA18C045013 AA18C045014 AA18C045015 AA18C045016 AA18C045017 AA18C045018 AA18C045019 AA18C045020 AA18C045021 AA18C045022 AA18C045023 AA18C045024 AA18C045025 AA18C045026 AA18C045027 AA18C045028 AA18C045029 AA18C045030 AA18C045031 AA18C045032 AA18C045033 AA18C045034 AA18C045035 AA18C045036 AA18C045037 AA18C045038 AA18C045039 AA18C045040 AA18C045041 AA18C045042 AA18C045043 AA18C045044 AA18C045045 AA18C045046 AA18C045047 AA18C045048 AA18C045049 AA18C045050 AA18C045051 AA18C045052 AA18C045053 AA18C045054 AA18C045055 AA18C045056 AA18C045057 AA18C045058 AA18C045059 AA18C045060 AA18C045061 AA18C045062 AA18C045063 AA18C045064 AA18C045065 AA18C045070 AA18C045071 AA18C045072 AA18C045073 AA18C045074 AA18C045075 AA18C045076 AA18C045077 AA18C045078 AA18C045079 AA18C045080 AA18C045081 AA18C045082 AA18C045083 AA18C045084 AA18C045085 AA18C045086 AA18C045087 AA18C045088 AA18C045089 AA18C045090 AA18C045091 AA18C045092 AA18C045093 AA18C045094 AA18C045095 AA18C045096 AA18C045097 AA18C045098 AA18C045099 AA18C045100 AA18C045101 AA18C045102 AA18C045103 AA18C045104 AA18C045105 AA18C045106 AA18C045107 AA18C045108 AA18C045109 AA18C045110 AA18C045111 AA18C045112 AA18C045113 AA18C045114 AA18C045115 AA18C045116 AA18C045117 AA18C045118 AA18C045119 AA18C045120 AA18C045121 AA18C045122 AA18C045123 AA18C045124 AA18C045125 AA18C045126 AA18C045127 AA18C045128 AA18C045129 AA18C045130 AA18C045131 AA18C045144 AA18C045145 AA18C045146 AA18C045147 AA18C045148 AA18C045149 AA18C045150 AA18C045151 AA18C045152 AA18C045153 AA18C045251 AA18C045252 AA18C045253 AA18C045254 AA18C045255 AA18C045256 AA18C045257 AA18C045258 AA18C045259 AA18C045260 AA18C045261 AA18C045262 AA18C045263 AA18C045264 AA18D045265 AA18D045266 AA18D045267 AA18D045268 AA18D045269 AA18D045270 AA18D045271 AA18D045272 AA18D045273 AA18D045274 AA18D045275 AA18D045276 AA18D045277 AA18D045278 AA18D045279 AA18D045280 AA18D045281 AA18D045282 AA18D045283 AA18D045284 AA18D045285 AA18D045286 AA18D045287 AA18D045288 AA18D045289 AA18D045290 AA18D045291 AA18D045292 AA18D045293 AA18D045294 AA18D045295 AA18D045296 AA18D045297 AA18D045298 AA18D045299 AA18D045300 AA18D045301 AA18D045302 AA18D045303 AA18D045304 AA18D045305 AA18D045306 AA18D045307 AA18D045308 AA18D045309 AA18D045310 AA18D045311 AA18D045312 AA18D045313 AA18D045314 AA18D045315 AA18D045332 AA18D045333 AA18D045334 AA18D045335 AA18D045336 AA18D045337 AA18D045338 AA18D045339 AA18D045340 AA18D045341 AA18D045342 AA18D045343 AA18D045344 AA18D045345 AA18D045349 AA18D045350 AA18D045351 AA18D045352 AA18D045353 AA18D045354 AA18D045355 AA18D045356 AA18D045357 AA18D045358 AA18D045359 AA18D045360 AA18D045361 AA18D045362 AA18D045363 AA18D045364 AA18D045365 AA18D045366 AA18D045367 AA18D045368 AA18D045369 AA18D045370 AA18D045371 AA18D045372 AA18D045373 AA18D045374 AA18D045375 AA18D045376 AA18D045377 AA18D045378 AA18D045379 AA18D045380 AA18D045381 AA18D045382 AA18D045383 AA18D045384 AA18D045385 AA18D045386 AA18D045387 AA18D045388 AA18D045389 AA18D045390 AA18D045391 AA18D045392 AA18D045393 AA18D045394 AA18D045395 AA18D045396 AA18D045397 AA18D045398 AA18D045399 AA18D045400 AA18D045401 AA18D045402 AA18D045403 AA18D045404 AA18D045405 AA18D045406 AA18D045407 AA18D045408 AA18D045409 AA18D045410 AA18D045411 AA18D045412 AA18D045413 AA18D045414 AA18D045415 AA18D045416 AA18D045417 AA18D045418 AA18D045419 AA18D045420 AA18D045421 AA18D045422 AA18D045423 AA18D045424 AA18D045425 AA18D045426 AA18D045427 AA18D045428 AA18D045429 AA18D045430 AA18D045431 AA18D045432 AA18D045433 AA18D045434 AA18D045435 AA18D045436 AA18D045437 AA18D045438 AA18D045439 AA18D045440 AA18D045441 AA18D045442 AA18D045443 AA18D045444 AA18D045445 AA18D045446 AA18D045447 AA18D045448 AA18D045449 AA18D045450 AA18D045451 AA18D045452 AA18D045453 AA18D045454 AA18D045455 AA18D045456 AA18D045457 AA18D045458 AA18D045459 AA18D045460 AA18D045461 AA18D045462 AA18D045463 AA18D045464 AA18D045465 AA18D045505 AA18D045506 AA18D045507 AA18D045509 AA18D045510 AA18D045511 AA18D045512 AA18D045513 AA18D045514 AA18D045515 AA18D045516 AA18D0455… (truncated, 23854 characters total — see the official FDA record for the full value)
Recalling firm:
ZOLL Medical Corporation
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2019

CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.

If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.

ALL 50 STATES
▸Full report

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

Recall #:
82897
Lot/product code:
All serial numbers affected
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2019

CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.

If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.

ALL 50 STATES
▸Full report

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

Recall #:
82897
Lot/product code:
All serial numbers affected
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2019

Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.

If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being provided.

ALL 50 STATES
▸Full report

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

Recall #:
82897
Lot/product code:
All serial numbers affected
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2019

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.

Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.

ALL 50 STATES
▸Full report

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

Recall #:
82897
Lot/product code:
All serial numbers affected
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2019

CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.

If battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.

ALL 50 STATES
▸Full report

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

Recall #:
82897
Lot/product code:
All serial numbers affected
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 17, 2019

CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.

If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered.

ALL 50 STATES
▸Full report

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

Recall #:
82897
Lot/product code:
All serial numbers affected
Recalling firm:
Datascope Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 25, 2019

MAGEC 1 System

Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

ALL 50 STATES
▸Full report

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

Recall #:
89177
Lot/product code:
All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.
Recalling firm:
NuVasive Specialized Orthopedics, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 27, 2019

Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

ALL 50 STATES
▸Full report

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

Recall #:
83433
Lot/product code:
All software versions 2.6A or lower. Available outside the US only.
Recalling firm:
Medtronic MiniMed
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 27, 2019

MiniMed Paradigm Insulin pump, model number MMT-712

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

ALL 50 STATES
▸Full report

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

Recall #:
83433
Lot/product code:
All software Versions
Recalling firm:
Medtronic MiniMed
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 27, 2019

Medtronic MiniMed Paradigm Insulin pump, model number MMT-522

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

ALL 50 STATES
▸Full report

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

Recall #:
83433
Lot/product code:
All software versions
Recalling firm:
Medtronic MiniMed
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 27, 2019

Medtronic MiniMed Paradigm Insulin pump, model number MMT-722

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

ALL 50 STATES
▸Full report

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

Recall #:
83433
Lot/product code:
All software Versions
Recalling firm:
Medtronic MiniMed
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 27, 2019

MiniMed Paradigm Model 511 Insulin Pump

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

ALL 50 STATES
▸Full report

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

Recall #:
83433
Lot/product code:
All Software Versions
Recalling firm:
Medtronic MiniMed
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled June 27, 2019

MiniMed Insulin Pump, model # MMT-508

The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

ALL 50 STATES
▸Full report

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

Recall #:
83433
Lot/product code:
All Software Versions
Recalling firm:
Medtronic MiniMed
View official FDA record (opens in a new tab)