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Recalls affecting Massachusetts

Data last updated: September 7, 2026 at 12:15 AM UTC

16,837 recalls found

Just announced

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

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

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

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

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

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

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

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

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

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

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

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

Company contact: recalls@bbraunusa.com

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

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

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

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

Company contact: Info.foodsafety@comfrut.com

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

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

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

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

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

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

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

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

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

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

Everything SproutsRobust Radish Mix, 5oz Cups

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

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IHigh risk
DrugRecalled July 2, 2015

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

ALL 50 STATES
Full report

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

Recall #:
D-1165-2016
Lot/product code:
Lot 1220062085, Exp. 09/16
Recalling firm:
XTREME Z DISTRIBUTORS INC
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled July 13, 2015

Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida

Marketed Without An Approved NDA/ANDA: Dietary supplements contains not listed on the label sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.

ALL 50 STATES
Full report

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

Recall #:
D-0664-2016
Lot/product code:
Lot # 000815004400; Exp 12/17
Recalling firm:
Life and More LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 16, 2015

Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB

Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination.

ALL 50 STATES
Full report

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

Recall #:
71724
Lot/product code:
Lots begin with: 15AMLB, 15BMLB, 15CMLB.
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled July 17, 2015

LYFO Disk

LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

ALL 50 STATES
Full report

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

Recall #:
89513
Lot/product code:
Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
Recalling firm:
Microbiologics Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 25, 2015

1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

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-1815-2015
Lot/product code:
Lot #: 44-359-DK, Exp 08/01/2016
Recalling firm:
Hospira, Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled August 27, 2015

MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354.

Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain not listed on the label thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.

ALL 50 STATES
Full report

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

Recall #:
D-0229-2016
Lot/product code:
All lots through Expiration Date 06/01/2018
Recalling firm:
The One Minute Miracle Inc
View official FDA record (opens in a new tab)
Class IHigh risk
DrugUndeclaredRecalled August 27, 2015

MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768.

Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain not listed on the label phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.

ALL 50 STATES
Full report

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

Recall #:
D-0230-2016
Lot/product code:
All lots through Expiration Date 04/15/2018
Recalling firm:
The One Minute Miracle Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled September 29, 2015

Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29

Failed Impurities/Degradation Specifications: not meeting quality requirements(OOS) results for degradation product of etomidate was confirmed during stability testing.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0054-2016
Lot/product code:
Lot 34-531-DK, Exp 10/01/2015
Recalling firm:
Hospira Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled October 1, 2015

The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).

ALL 50 STATES
Full report

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

Recall #:
72436
Lot/product code:
Serial Numbers A1221, A1226 (Ship Date 07/2015);   Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015);   Serial Number A1246 (Ship Date 04/2015);   Serial Numbers A1245, A1244, A1042, A1243 (Ship Date 02/2015);   Serial Number A1225 (Ship Date 01/2015);   Serial Numbers A1241, A1242 (Ship Date 12/2014);   Serial Number A1036 (Ship Date 11/2014);   Serial Numbers A1229, A1247, A1224 (Ship Date 10/2014);   Serial Numbers A1239, A1234, A1236, A1237, A1238, A1233, A1228, A1231, A1232, A1235 (Ship Date 09/2014);   Serial Number A1227 (Ship Date 08/2014);   Serial Number A1223 (Ship Date 07/2014);   Serial Numbers A1218, A1220 (Ship Date 06/2014);   Serial Numbers A1217, A1216, A1248 (Ship Date 04/2014);   Serial Numbers A1214, A1064 (Ship Date 03/2014);   Serial Numbers A1087, A1213 (Ship Date 01/2014);   Serial Numbers A1201, A1203, A1204, A1205, A1206, A1209, A1210, A1211, A1212, A1094, A1200, A1207, A1091, A1092, A1093, A1201 (Ship Date 12/2013;   Serial Numbers A1075, A1076, A1077, A1078, A1079, A1080, A1081, A1082, A1083, A1070, A1072, A1073, A1084, A1086, A1087, A1088, A1089, A1090, A1085 (Ship Date 11/2013);   Serial Numbers A1022, A1044 (Ship Date 10/2013);   Serial Number A1059 (Ship Date 09/2013);   Serial Numbers A1021, A1060, A1062, A1063, A1065, A1066, A1067, A1069 (Ship Date 08/2013);   Serial Numbers A1037, A1005, A1015, A1024, A1230, A1050, A1051, A1052, A1053, A1054, A1055, A1058, A1016, A1019, A1064, A1249 (Ship Date 07/2013);   Serial Numbers A1006, A1020, A1004, A1023, A1021 (Ship Date 05/2013);   Serial Numbers A1025, A1046, A1032 (Ship Date 04/2013);   Serial Numbers A1038, A1049, A1029, A1026, A1035, A1039, A1036, A1031, A1030, A1028, A1027, A1034 (Ship Date 03/2013);   Serial Number P11 (Ship Date 02/2013);   Serial Number P-7 (Ship Date 11/2012);   Serial Numbers A1013, P-8 (Ship Date 09/2012);   Serial Numbers A1043, P-6, A1041, P-9 (Ship Date 07/2012);
Recalling firm:
Powers Medical Devices, LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 2, 2015

Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.

ALL 50 STATES
Full report

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

Recall #:
72542
Lot/product code:
4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)
Recalling firm:
Trumpf Medical Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled December 3, 2015

Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.

There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.

ALL 50 STATES
Full report

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

Recall #:
89144
Lot/product code:
Medfusion 3500 and 4000 Syringe Infusion Pumps manufactured between April 2012 and June 2015; and Medfusion 3010 and 3010A (and pump models 3500 and 40000 serviced during April 20121 and June 2015 in which a main board was replaced.
Recalling firm:
Smiths Medical ASD Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled December 23, 2015

APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.

ALL 50 STATES
Full report

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

Recall #:
D-0667-2016
Lot/product code:
All lots
Recalling firm:
Nuway Distributors, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled January 20, 2016

Fruit Tartlets, Raspberry flavor, 9 - 0.56oz (16 g) tartlets - Net Wt. 5.1oz (145 g). Manufactured in France. Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL

Products contain not listed on the label milk on finished product labeling

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 #:
F-1420-2016
Lot/product code:
Lot Code (Exp date): 08212016 (08212016), 100116 (100116), 100122016 (100122016), 100216 (100216), 10302016 (10302016), 111316 (111316).
Recalling firm:
Ouhlala Gourmet Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled January 20, 2016

Fruit Tartlets, lemon flavor, 9 - 0.53oz (15 g) tartlets - Net Wt. 4.8 oz (135 g). Manufactured in France. Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL

Products contain not listed on the label milk on finished product labeling

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 #:
F-1419-2016
Lot/product code:
Lot Code (Exp date): 08192016 (08192016), 09292016 (09292016), 10092015 (10092015), 10302016 (10302016), 10312016 (10312016), 111216 (111216), 10012016 (10012016), 09292016 (09292016), 10312016 (10312016). Item GTIN #00810387020566. Case UPC #20854417002430.
Recalling firm:
Ouhlala Gourmet Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled February 1, 2016

Lysander's All Natural Spicy Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g) foil bag, 6 units per case. Manufactured by Geneva Foods, LLC.

Product contains not listed on the label allergens soy and wheat. Also does not declare sulfites.

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 #:
F-2080-2016
Lot/product code:
Lot codes ending in 14 or 15; UPC: 0-34795-00051-8
Recalling firm:
Geneva Foods, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled February 1, 2016

Lysander's All Natural Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g), foil bag, 6 units per case. Manufactured by Geneva Foods, LLC.

Product contains not listed on the label allergens soy and wheat. Also does not declare sulfites.

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 #:
F-2081-2016
Lot/product code:
Lot codes ending in 14 or 15; UPC: 0-34795-00049-5.
Recalling firm:
Geneva Foods, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled February 1, 2016

Lysander's Premium Teriyaki Marinade, 1 oz (28 g), polypropylene and clamshell style card, 12 units per case. Manufactured by Geneva Foods, LLC.

Product contains not listed on the label allergens soy and wheat. Also does not declare sulfites.

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 #:
F-2079-2016
Lot/product code:
Cases coded 2014-2015, if not visible all lots; UPC: 0-34795-00036-5.
Recalling firm:
Geneva Foods, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled February 2, 2016

Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.

Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0727-2016
Lot/product code:
Lot #: 56-853-FW, Exp 01AUG2017
Recalling firm:
Hospira Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 19, 2016

Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

Full report

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

Recall #:
73459
Lot/product code:
13101261
Recalling firm:
Villa Radiology Systems LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 19, 2016

Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

Full report

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

Recall #:
73459
Lot/product code:
08090531 09090591 10040680 15051450 11020798
Recalling firm:
Villa Radiology Systems LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 19, 2016

Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

Full report

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

Recall #:
73459
Lot/product code:
10110770 11030805 11030806 11070845 11070848 11070849 11090864 11110900 12020978 12020982 12030999 12041003 12061014 12061018 12061020 12081040 12091074 12101104 12121186 12121187 13031215 13101263 14021301 14031313 14041321 14051332 14071353 14081359 14091368 14091371 14121400 14121403 15021426 15031440 15041444 15091473 15091478 15101484 15101487
Recalling firm:
Villa Radiology Systems LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 19, 2016

Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.

The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.

Full report

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

Recall #:
73459
Lot/product code:
06040078 07030172 06090116 06110138 07010149 07020158 07020162 07020163 07020165 07030168 07030171 07040206 09090605 10100752 06060086 06100127 09010566 08020473 11100873 15041446
Recalling firm:
Villa Radiology Systems LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled February 29, 2016

Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

Lot was not functioning properly and not exhibiting the correct physical properties.

ALL 50 STATES
Full report

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

Recall #:
77481
Lot/product code:
P/N 5409; Lot No. 15251; Exp. Date 09/2016
Recalling firm:
AMS Diagnostics, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled March 15, 2016

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0836-2016
Lot/product code:
Lot 52-045-EV, Exp 07/1/2016
Recalling firm:
Hospira Inc.
View official FDA record (opens in a new tab)
Class IHigh risk
DrugRecalled March 18, 2016

8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

ALL 50 STATES
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The most serious kind of recall. Using this product could cause serious health problems or death.

Recall #:
D-0865-2016
Lot/product code:
Lot # 56-148-EV, Exp 8/1/2017
Recalling firm:
Hospira Inc.
View official FDA record (opens in a new tab)