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Recalls affecting Puerto Rico

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

16,293 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)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

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

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

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

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

Contains garlic essential oil not approved for culinary use

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Food & BeveragesIngredients

Recalling firm: LMSI LLC

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

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

Everything Sprouts — Robust Radish Mix, 5oz Cups

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

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

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

Company contact: everythingsproutsmn@gmail.com

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

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

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

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O; 5) OPEN HEART CDSKit SKU DYNJ902879T; 6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F; 7) OPEN HEART CDSKit SKU DYNJ905557B; 8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline SKU PHS972096014B, UDI/DI 10889942695911 (EA) 40889942695912 (CS), Lot Number 25GBY100; Medline SKU CDS984289O, UDI/DI 10198459418143 (EA) 40198459418144 (CS), Lot Number 25HBI736; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBL296; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25HBN030; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25HLA445; Medline SKU DYKM1025D, UDI/DI 10195327482893 (EA) 40195327482894 (CS), Lot Number 25HMA140; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IBI197; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IBL774; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25IMG620; Medline SKU DYNJ0394752O, UDI/DI 10193489432794 (EA) 40193489432795 (CS), Lot Number 25IMH657; Medline SKU PHS972012D, UDI/DI 10193489571875 (EA) 40193489571876 (CS), Lot Number 25IMH924; Medline SKU DYNJ905557B, UDI/DI 10193489468243 (EA) 40193489468244 (CS), Lot Number 25JBH529; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25JBO555; Medline SKU DYNJ903523F, UDI/DI 10198459316593 (EA) 40198459316594 (CS), Lot Number 25JLA937; Medline SKU CDS984355K, UDI/DI 10198459258848 (EA) 40198459258849 (CS), Lot Number 25KBB119; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512; Medline SKU DYNJ902879T, UDI/DI 10195327461294 (EA) 40195327461295 (CS), Lot Number 25KBH512.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.

Cook Medical identified that products supplied in the affected device lots may have been manufactured not meeting quality requirements. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

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

Recall #:
98027
Lot/product code:
1) Reference Part Number RTPS-100: Order Number G06541, UDI (01)00827002065413(17)280722(10)16705779, Lot Number 16705779; 2) Reference Part Number RTPS-100-10.0: Order Number G29769, UDI (01)00827002297692(17)280624(10)16659044, Lot Number 16659044
Recalling firm:
Cook Incorporated
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, Medline kit SKU DYNJ38935

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
UDI/DI 10884389725092 (EA) 40884389725093 (CS), Lot number 25IBC144
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline kit SKU DYNJ0785864R, UDI/DI 10195327656454 (EA) 40195327656455 (CA), Lot Number 25HMB184; Medline kit SKU DYNJ0792607R, UDI/DI 10198459503023 (EA) 40198459503024 (CA). Lot number 25JMH400.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972096014B

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
UDI/DI 10889942695911 (EA) 40889942695912 (CA), Lot Numbers: 25JMC398
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP ACCESSORY, Medline kit SKU DYNJ63395B

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
UDI/DI 10195327634698 (EA) 40195327634699 (CS), Lot numbers: 25HLA435, 25HLB046.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline kit SKU PHS972096014B UDI/DI: 10889942695911 (EA) 40889942695912 (CS), Lot Number 25IBT843; Medline kit SKU CDS984289O UDI/DI: 10198459418143 (EA) 40198459418144 (CS), Lot Number 25IMA327; Medline kit SKU DYNJ903523F UDI/DI: 10198459316593 (EA) 40198459316594 (CS), Lot Number 25IMI028.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SKU DYNJ66311C; 3) DISCECTOMY PACK, Medline kit SKU DYNJ86770; 4) TOTAL KNEE, Medline kit SKU DYNJ909643F.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline kit SKU DYNJ0395085V,UDI/DI 10198459313745 (EA) 40198459313746 (CS), Lot Number 25HMC337; Medline kit SKU DYNJ66311C,UDI/DI 10198459364556 (EA) 40198459364557 (CS), Lot Number 25KBG419; Medline kit SKU DYNJ86770,UDI/DI 10195327674229 (EA) 40195327674220 (CS), Lot Number 25IBU284; Medline kit SKU DYNJ86770,UDI/DI 10195327674229 (EA) 40195327674220 (CS), Lot Number 25KBJ623; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25HBU964; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25IBV819; Medline kit SKU DYNJ909643F,UDI/DI 10198459392603 (EA) 40198459392604 (CS), Lot Number 25KBF028.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS1534D.

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

ALL 50 STATES
▸Full report

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

Recall #:
98154
Lot/product code:
Medline kit SKU DYKS1339B, UDI/DI 10195327386726(EA) 40195327386727 (CS) , Lot Number 25HMC849; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25IMG807; Medline kit SKU DYKS1339C, UDI/DI 10198459523434(EA) 40198459523435 (CS) , Lot Number 25JMF937; Medline kit SKU DYKS1359B, UDI/DI 10195327566449(EA) 40195327566440 (CS) , Lot Number 25JMD518; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25HMD322; Medline kit SKU DYKS1534D, UDI/DI 10198459310911(EA) 40198459310912 (CS) , Lot Number 25JMG543.
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 26, 2025

Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10.

Weaker than it should be product:not meeting quality requirements assay results observed during long term 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-0236-2026
Lot/product code:
Lot#: A240438, Exp Date 1/31/26, A250125, Exp Date 8/31/26
Recalling firm:
SOMERSET THERAPEUTICS LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 26, 2025

Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

ALL 50 STATES
▸Full report

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

Recall #:
97889
Lot/product code:
REF/UDI-DI: 00-1004/05060472440624; 00-1007/05060472440655; 00-1004-R/05060472440020, 05060472442901; 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932; User/Operator Manual Version 41-2001EN Serial Numbers: 30264 616174 616689 616695 616701 616703 616706 615658 615668 615551 615552 615555 615556 615557 615559 602803 602941 603335 603342 603406 603407 603409 603410 603412 602157 602159 602160 602163 602164 602168 602169 602170 602171 602172 615637 616688 614764 615435 615526 615604 615606 615607 615623 603631 604118 604119 604120 604127 604130 604138 616466 602877 602895 616584 616581 603518 603529 603555 614730 614734 614736 614737 614958 614970 614971 614972 614973 616719 616720 616725 616727 616978 616432 30100 30201 30202 30203 616491 616492 616493 616494 616496 616500 616503 616456 600613 615937 616338 616380 616678 616679 616683 616685 616687 616702 616344 616351 616384 616604 616608 616614 616682 616690 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6038… (truncated, 49736 characters total — see the official FDA record for the full value)
Recalling firm:
Remote Diagnostic Technologies Ltd.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 26, 2025

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4

Failed Impurities/Degradation: not meeting quality requirements results for Total Impurities and for Assay.

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-0257-2026
Lot/product code:
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 26, 2025

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

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-0223-2026
Lot/product code:
Lot 1312405; Exp 09/28/2027
Recalling firm:
Winder Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled November 26, 2025

Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10.

Weaker than it should be product:not meeting quality requirements assay results observed during long term stability testing.

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

Recall #:
D-0237-2026
Lot/product code:
Lot #: A250020, Exp Date 06/30/2026
Recalling firm:
SOMERSET THERAPEUTICS LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 25, 2025

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No

Butyrate tube cracks during actuation, rendering product unusable.

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

Recall #:
98035
Lot/product code:
Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488
Recalling firm:
Ferndale Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 24, 2025

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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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-0216-2026
Lot/product code:
Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Recalling firm:
Breckenridge Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled November 24, 2025

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

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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-0215-2026
Lot/product code:
Lot #: 240947C, 240962C, Exp. Date 04/2027
Recalling firm:
Breckenridge Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Removal of affected lot of screws due to labeling error.

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

Recall #:
98051
Lot/product code:
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
Recalling firm:
Smith & Nephew, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.

A certain component of affected devices was not delivered within specification and contained impurities.

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

Recall #:
98002
Lot/product code:
Model No. M36500; UDI-DI: 04048675301363; Serial No. ASUK-1181,ASUK-1186,ASUK-1187,ASUK-1196,ASUK-1197,ASUK-1198,ASUK-1199,ASUK-1200, ASUK-1201,ASUK-1202,ASUK-1203,ASUK-1204,ASUK-1205,ASUK-1206,ASUK-1207,ASUK-1208, ASUK-1209,ASUK-1210,ASUK-1211,ASUK-1212,ASUK-1213,ASUK-1214,ASUK-1215,ASUK-1216, ASUK-1217,ASUK-1218,ASUK-1219,ASUK-1220,ASUK-1590,ASUK-1591,ASUK-1592,ASUK-1611, ASUK-1613,ASUK-1616,ASUK-1617,ASUK-1618,ASUK-1619, ASUK-0241,ASUK-0242,ASUK-0243,ASUK-0244,ASUK-0245,ASUK-0246,ASUK-0247,ASUK-0248, ASUK-0249,ASUK-0250,ASUK-0451,ASUK-0452,ASUK-0453,ASUK-0454,ASUK-0455,ASUK-0456, ASUK-0457,ASUK-0458,ASUK-0459,ASUK-0460,ASUK-0461,ASUK-0462,ASUK-0463,ASUK-0464, ASUK-0465,ASUK-0466,ASUK-0467,ASUK-0468,ASUK-0469,ASUK-0470,ASUK-0471,ASUK-0472, ASUK-0473,ASUK-0474,ASUK-0475,ASUK-0476,ASUK-0477,ASUK-0478,ASUK-0479,ASUK-0480, ASUK-0481,ASUK-0482,ASUK-0483,ASUK-0484,ASUK-0486,ASUK-0487,ASUK-0488,ASUK-0489, ASUK-0490,ASUK-0491,ASUK-0492,ASUK-0493,ASUK-0494,ASUK-0495,ASUK-0496,ASUK-0497, ASUK-0498,ASUK-0499,ASUK-0500,ASUK-0501,ASUK-0502,ASUK-0503,ASUK-0504,ASUK-0505, ASUK-0506,ASUK-0507,ASUK-0508,ASUK-0509,ASUK-0510,ASUK-0511,ASUK-0512,ASUK-0513, ASUK-0514,ASUK-0515,ASUK-0516,ASUK-0517,ASUK-0518,ASUK-0519,ASUK-0520,ASUK-0521, ASUK-0522,ASUK-0523,ASUK-0524,ASUK-0525,ASUK-0526,ASUK-0527,ASUK-0528,ASUK-0529, ASUK-0530,ASUK-0531,ASUK-0532,ASUK-0533,ASUK-0534,ASUK-0535,ASUK-0536,ASUK-0537, ASUK-0538,ASUK-0539,ASUK-0540,ASUK-0541,ASUK-0542,ASUK-0543,ASUK-0544,ASUK-0545, ASUK-0546,ASUK-0547,ASUK-0548,ASUK-0549,ASUK-0550,ASUK-0551,ASUK-0552,ASUK-0553, ASUK-0554,ASUK-0555,ASUK-0556,ASUK-0557,ASUK-0558,ASUK-0559,ASUK-0560,ASUK-1181, ASUK-1182,ASUK-1183,ASUK-1184,ASUK-1185,ASUK-1191,ASUK-1192,ASUK-1193,ASUK-1194, ASUK-1195,ASUK-1581,ASUK-1582,ASUK-1583,ASUK-1584,ASUK-1585,ASUK-1586,ASUK-1587, ASUK-1588,ASUK-1589,ASUK-1593,ASUK-1594,ASUK-1595,ASUK-1596,ASUK-1597,ASUK-1598, ASUK-1599,ASUK-1600,ASUK-1602,ASUK-1612,ASUK-1614,,ASUK-1615,ASUK-1620.
Recalling firm:
Draeger, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

A certain component of affected devices was not delivered within specification and contained impurities.

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

Recall #:
98002
Lot/product code:
Model No. M35054; UDI-DI: 04048675228059; Serial No. ASUK-0421,ASUK-0422,ASUK-0423,ASUK-0424,ASUK-0425,ASUK-0426,ASUK-0602,ASUK-0603, ASUK-0705,ASUK-0706,ASUK-0707,ASUK-0708,ASUK-0721,ASUK-0722,ASUK-0723,ASUK-0724, ASUK-0725,ASUK-0726,ASUK-0727,ASUK-0728,ASUK-0729,ASUK-0730,ASUK-0731,ASUK-0732, ASUK-0733,ASUK-0734,ASUK-0735,ASUK-0736,ASUK-0737,ASUK-0738,ASUK-0739,ASUK-0740, ASUK-0749,ASUK-0761,ASUK-0762,ASUK-0763,ASUK-0764,ASUK-0765,ASUK-0766,ASUK-0767, ASUK-0768,ASUK-0769,ASUK-0770,ASUK-0835,ASUK-0836,ASUK-0837,ASUK-0972,ASUK-0973, ASUK-0974,ASUK-0975,ASUK-0993,ASUK-0994,ASUK-0995,ASUK-0996,ASUK-0997,ASUK-0998, ASUK-0999,ASUK-1000,ASUK-1011,ASUK-1015,ASUK-1016,ASUK-1017,ASUK-1018,ASUK-1221, ASUK-1222,ASUK-1232,ASUK-1233,ASUK-1234,ASUK-1235,ASUK-1236,ASUK-1237,ASUK-1239, ASUK-1240,ASUK-1246,ASUK-1306,ASUK-1307,ASUK-1308,ASUK-1309,ASUK-1539,ASUK-1540, ASUK-0428,ASUK-0429,ASUK-0430,ASUK-0431,ASUK-0432,ASUK-0433,ASUK-0434,ASUK-0435, ASUK-0436,ASUK-0437,ASUK-0438,ASUK-0439,ASUK-0440,ASUK-0441,ASUK-0442,ASUK-0443, ASUK-0444,ASUK-0445,ASUK-0446,ASUK-0447,ASUK-0448,ASUK-0449,ASUK-0450,ASUK-0,63, ASUK-0564,ASUK-0565,ASUK-0566,ASUK-0567,ASUK-0568,ASUK-0569,ASUK-0570,ASUK-0571, ASUK-0572,ASUK-0573,ASUK-0574,ASUK-0575,ASUK-0576,ASUK-0577,ASUK-0578,ASUK-0579, ASUK-0580,ASUK-0581,ASUK-0582,ASUK-0583,ASUK-0584,ASUK-0585,ASUK-0601,ASUK-0604, ASUK-0605,ASUK-0606,ASUK-0607,ASUK-0608,ASUK-0609,ASUK-0610,ASUK-0631,ASUK-0632, ASUK-0633,ASUK-0634,ASUK-0635,ASUK-0636,ASUK-0637,ASUK-0638,ASUK-0639,ASUK-0640, ASUK-0641,ASUK-0642,ASUK-0661,ASUK-0662,ASUK-0663,ASUK-0664,ASUK-0667,ASUK-0668, ASUK-0681,ASUK-0682,ASUK-0691,ASUK-0692,ASUK-0693,ASUK-0694,ASUK-0695,ASUK-0696, ASUK-0697,ASUK-0698,ASUK-0699,ASUK-0700,ASUK-0711,ASUK-0712,ASUK-0713,ASUK-0714, ASUK-0715,ASUK-0716,ASUK-0717,ASUK-0718,ASUK-0719,ASUK-0720,ASUK-0741,ASUK-0742, ASUK-0743,ASUK-0744,ASUK-0746,ASUK-0747,ASUK-0748,ASUK-0750,ASUK-0751,ASUK-0752, ASUK-0753,ASUK-0754,ASUK-0755,ASUK-0756,ASUK-0757,ASUK-0758,ASUK-0759,ASUK-0760, ASUK-0778,ASUK-0779,ASUK-0780,ASUK-0781,ASUK-0782,ASUK-0783,ASUK-0784,ASUK-0785, ASUK-0786,ASUK-0787,ASUK-0788,ASUK-0789,ASUK-0790,ASUK-0791,ASUK-0792,ASUK-0793, ASUK-0794,ASUK-0795,ASUK-0796,ASUK-0797,ASUK-0798,ASUK-0799,ASUK-0800,ASUK-0801, ASUK-0802,ASUK-0803,ASUK-0804,ASUK-0805,ASUK-0810,ASUK-0816,ASUK-0817,ASUK-0818, ASUK-0819,,ASUK-0820,ASUK-0821,ASUK-0822,ASUK-0823,ASUK-0824,ASUK-0825,ASUK-0826, ASUK-0827,ASUK-0828,ASUK-0829,ASUK-0830,ASUK-0831,ASUK-0832,ASUK-0833,ASUK-0834, ASUK-0838,ASUK-0839,ASUK-0840,ASUK-0842,ASUK-0843,ASUK-0844,ASUK-0845,ASUK-0846, ASUK-0847,ASUK-0848,ASUK-0849,ASUK-0850,ASUK-0851,ASUK-0852,ASUK-0853,ASUK-0854, ASUK-0855,ASUK-0856,ASUK-0857,ASUK-0858,ASUK-0859,ASUK-0860,ASUK-0871,ASUK-0872, ASUK-0873,ASUK-0874,ASUK-0875,ASUK-0876,ASUK-0877,ASUK-0878,ASUK-0879,ASUK-0880, ASUK-0891,ASUK-0892,ASUK-0893,ASUK-0894,ASUK-0916,ASUK-0917,ASUK-0918,ASUK-0919, ASUK-0920,ASUK-0921,ASUK-0922,ASUK-0923,ASUK-0924,ASUK-0925,ASUK-0930,ASUK-0931, ASUK-0964,ASUK-0965,ASUK-0971,ASUK-0976,ASUK-0977,ASUK-0978,ASUK-0979,ASUK-0980, ASUK-0981,ASUK-0982,ASUK-0983,ASUK-0984,ASUK-0985,ASUK-0986,ASUK-0987,ASUK-0988, ASUK-0989,ASUK-0990,ASUK-0991,ASUK-0992,ASUK-1001,ASUK-1002,ASUK-1003,ASUK-1005, ASUK-1006,ASUK-1007,ASUK-1008,ASUK-1009,ASUK-1010,ASUK-1012,ASUK-1014,ASUK-1019, ASUK-1020,ASUK-1061,ASUK-1062,ASUK-1063,ASUK-1064,ASUK-1065,ASUK-1066,ASUK-1070, ASUK-1071,ASUK-1073,ASUK-1074,ASUK-1075,ASUK-1076,ASUK-1077,ASUK-1078,ASUK-1079, ASUK-1080,ASUK-1081,ASUK-1082,ASUK-1084,ASUK-1085,ASUK-1086,ASUK-1087,ASUK-1088, ASUK-1089,ASUK-1090,ASUK-1091,ASUK-1092,ASUK-1093,ASUK-1094,ASUK-1095,ASUK-1096, ASUK-1097,ASUK-1098,ASUK-1099,ASUK-1100,ASUK-1121,ASUK-1122,ASUK-1123,ASUK-1124, ASUK-1125,ASUK-1126,ASUK-1127,ASUK-1128,ASUK-1129,ASUK-1130,ASUK-1230,ASUK-1231, ASUK-1241,ASUK-1242,ASUK-1243,ASUK-1244,ASUK-1245,ASUK-1247,ASUK-1261,ASUK-1262, ASUK-1263,ASUK-1264,ASUK-1265,ASUK-1266,ASUK-1267,ASUK-1268,ASUK-1269,ASUK-1270, ASUK-1271,ASUK-1272,ASUK-1273,ASUK-1274,ASUK-1275,ASUK-1276,ASUK-1277,ASUK-1278, ASUK-1279,ASUK-1280,ASUK-1288,ASUK-1289,ASUK-1291,ASUK-1292,ASUK-1293,ASUK-1294, ASUK-1295,ASUK-1296,ASUK-1297,ASUK-1298,ASUK-1299,ASUK-1300,ASUK-1301,ASUK-1302, ASUK-1305,ASUK-1311,ASUK-1312,ASUK-1313,ASUK-1314,ASUK-1315,ASUK-1352,ASUK-1353, ASUK-1357,ASUK-1358,ASUK-1360,ASUK-1463,ASUK-1464,ASUK-1465,ASUK-1466,ASUK-1492, ASUK-1493,ASUK-1496,ASUK-1497,ASUK-1498,ASUK-1499,ASUK-1500,ASUK-1532.
Recalling firm:
Draeger, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

Ophthalmic procedure packs may have incomplete seals affecting sterility.

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

Recall #:
98055
Lot/product code:
UDI: *+H5301ALCON1CPAK10B* /9903-20 - Lot #17PJ9X, 17188-04 - Lot # 17PJAY, 19762-03 - Lot # 17PU09, 19203-04- Lot # 17PMWE, 19203-04 - Lot # 17PTXP, 17957-10- Lot #17PTXY
Recalling firm:
Alcon Research LLC
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

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

Recall #:
98000
Lot/product code:
version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Zimmer Dermatome AN, Model/Catalog Number: 88710100

The devices may have a misaligned thickness control bar.

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

Recall #:
98024
Lot/product code:
Lot Code: Model No 88710100, UDI 00889024464834701341, Lot Number 65900465, Serial Number 701341; Model No 88710100, UDI 00889024464834701343, Lot Number 65900465, Serial Number 701343; Model No 88710100, UDI 00889024464834701344, Lot Number 65900465, Serial Number 701344; Model No 88710100, UDI 00889024464834701345, Lot Number 65900465, Serial Number 701345; Model No 88710100, UDI 00889024464834701346, Lot Number 65900465, Serial Number 701346; Model No 88710100, UDI 00889024464834701350, Lot Number 65900465, Serial Number 701350; Model No 88710100, UDI 00889024464834701351, Lot Number 65900465, Serial Number 701351; Model No 88710100, UDI 00889024464834701352, Lot Number 65900465, Serial Number 701352; Model No 88710100, UDI 00889024464834701353, Lot Number 65900465, Serial Number 701353; Model No 88710100, UDI 00889024464834701354, Lot Number 65900465, Serial Number 701354; Model No 88710100, UDI 00889024464834701355, Lot Number 65900465, Serial Number 701355; Model No 88710100, UDI 00889024464834701356, Lot Number 65900465, Serial Number 701356; Model No 88710100, UDI 00889024464834701357, Lot Number 65900465, Serial Number 701357; Model No 88710100, UDI 00889024464834701359, Lot Number 65900465, Serial Number 701359; Model No 88710100, UDI 00889024464834701361, Lot Number 65944825, Serial Number 701361; Model No 88710100, UDI 00889024464834701362, Lot Number 65944825, Serial Number 701362; Model No 88710100, UDI 00889024464834701363, Lot Number 65944825, Serial Number 701363; Model No 88710100, UDI 00889024464834701364, Lot Number 65944825, Serial Number 701364; Model No 88710100, UDI 00889024464834701365, Lot Number 65944825, Serial Number 701365; Model No 88710100, UDI 00889024464834701366, Lot Number 65944825, Serial Number 701366; Model No 88710100, UDI 00889024464834701367, Lot Number 65944825, Serial Number 701367; Model No 88710100, UDI 00889024464834701368, Lot Number 65944825, Serial Number 701368; Model No 88710100, UDI 00889024464834701369, Lot Number 65944825, Serial Number 701369; Model No 88710100, UDI 00889024464834701370, Lot Number 65944825, Serial Number 701370; Model No 88710100, UDI 00889024464834701371, Lot Number 65944825, Serial Number 701371; Model No 88710100, UDI 00889024464834701372, Lot Number 65944825, Serial Number 701372; Model No 88710100, UDI 00889024464834701374, Lot Number 65944825, Serial Number 701374; Model No 88710100, UDI 00889024464834701375, Lot Number 65944825, Serial Number 701375; Model No 88710100, UDI 00889024464834701376, Lot Number 65944825, Serial Number 701376; Model No 88710100, UDI 00889024464834701377, Lot Number 65944825, Serial Number 701377; Model No 88710100, UDI 00889024464834701378, Lot Number 65944825, Serial Number 701378; Model No 88710100, UDI 00889024464834701379, Lot Number 65944825, Serial Number 701379; Model No 88710100, UDI 00889024464834701380, Lot Number 65944825, Serial Number 701380; Model No 88710100, UDI 00889024464834701381, Lot Number 66016265, Serial Number 701381; Model No 88710100, UDI 00889024464834701386, Lot Number 66016265, Serial Number 701386; Model No 88710100, UDI 00889024464834701387, Lot Number 66016265, Serial Number 701387; Model No 88710100, UDI 00889024464834701388, Lot Number 66016265, Serial Number 701388; Model No 88710100, UDI 00889024464834701390, Lot Number 66016265, Serial Number 701390; Model No 88710100, UDI 00889024464834701391, Lot Number 66016265, Serial Number 701391; Model No 88710100, UDI 00889024464834701393, Lot Number 66016265, Serial Number 701393; Model No 88710100, UDI 00889024464834701395, Lot Number 66016265, Serial Number 701395; Model No 88710100, UDI 00889024464834701396, Lot Number 66016265, Serial Number 701396; Model No 88710100, UDI 00889024464834701397, Lot Number 66016265, Serial Number 701397; Model No 88710100, UDI 00889024464834701398, Lot Number 66016265, Serial Number 701398; Model No 88710100, UDI 00889024464834701399, Lot Number 66016265, Serial Number 701399; Model No 88710100, UDI 00889024464834701400, Lot Number 66016265, Serial Number 701400; Model No 88710100, UDI 00889024464834701402, Lot Number 66121190, Serial Number 701402; Model No 88710100, UDI 00889024464834701403, Lot Number 66121190, Serial Number 701403; Model No 88710100, UDI 00889024464834701404, Lot Number 66121190, Serial Number 701404; Model No 88710100, UDI 00889024464834701405, Lot Number 66121190, Serial Number 701405; Model No 88710100, UDI 00889024464834701406, Lot Number 66121190, Serial Number 701406; Model No 88710100, UDI 00889024464834701410, Lot Number 66121190, Serial Number 701410; Model No 88710100, UDI 00889024464834701411, Lot Number 66121190, Serial Number 701411; Model No 88710100, UDI 00889024464834701413, Lot Number 66121190, Serial Number 701413; Model No 88710100, UDI 00889024464834701415, Lot Number 66121190, Serial Number 701415; Model No 88710100, UDI 00889024464834701416, Lot Number 66121190, Serial Number 701416; Model No 88710100, UDI 00889024464834701417, Lot Number 661211… (truncated, 44185 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

The devices may have a misaligned thickness control bar.

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

Recall #:
98024
Lot/product code:
Lot Code: Model No 00880100100, UDI (01)00889024375901(21)115821, Lot Number 65944745, Serial Number 115821; Model No 00880100100, UDI (01)00889024375901(21)115824, Lot Number 65944745, Serial Number 115824; Model No 00880100100, UDI (01)00889024375901(21)115826, Lot Number 65944745, Serial Number 115826; Model No 00880100100, UDI (01)00889024375901(21)115827, Lot Number 65944745, Serial Number 115827; Model No 00880100100, UDI (01)00889024375901(21)115829, Lot Number 65944745, Serial Number 115829; Model No 00880100100, UDI (01)00889024375901(21)115831, Lot Number 65944745, Serial Number 115831; Model No 00880100100, UDI (01)00889024375901(21)115832, Lot Number 65944745, Serial Number 115832; Model No 00880100100, UDI (01)00889024375901(21)115834, Lot Number 65944745, Serial Number 115834; Model No 00880100100, UDI (01)00889024375901(21)115835, Lot Number 65944745, Serial Number 115835; Model No 00880100100, UDI (01)00889024375901(21)115836, Lot Number 65944745, Serial Number 115836; Model No 00880100100, UDI (01)00889024375901(21)115838, Lot Number 65944745, Serial Number 115838; Model No 00880100100, UDI (01)00889024375901(21)115839, Lot Number 65944748, Serial Number 115839; Model No 00880100100, UDI (01)00889024375901(21)115841, Lot Number 65944748, Serial Number 115841; Model No 00880100100, UDI (01)00889024375901(21)115842, Lot Number 65944748, Serial Number 115842; Model No 00880100100, UDI (01)00889024375901(21)115843, Lot Number 65944748, Serial Number 115843; Model No 00880100100, UDI (01)00889024375901(21)115845, Lot Number 65944748, Serial Number 115845; Model No 00880100100, UDI (01)00889024375901(21)115846, Lot Number 65944748, Serial Number 115846; Model No 00880100100, UDI (01)00889024375901(21)115847, Lot Number 65944748, Serial Number 115847; Model No 00880100100, UDI (01)00889024375901(21)115848, Lot Number 65944748, Serial Number 115848; Model No 00880100100, UDI (01)00889024375901(21)115850, Lot Number 65944748, Serial Number 115850; Model No 00880100100, UDI (01)00889024375901(21)115853, Lot Number 65944748, Serial Number 115853; Model No 00880100100, UDI (01)00889024375901(21)115854, Lot Number 65944748, Serial Number 115854; Model No 00880100100, UDI (01)00889024375901(21)115855, Lot Number 65944748, Serial Number 115855; Model No 00880100100, UDI (01)00889024375901(21)115856, Lot Number 65944748, Serial Number 115856; Model No 00880100100, UDI (01)00889024375901(21)115857, Lot Number 65944748, Serial Number 115857; Model No 00880100100, UDI (01)00889024375901(21)115858, Lot Number 65944748, Serial Number 115858; Model No 00880100100, UDI (01)00889024375901(21)115859, Lot Number 65944750, Serial Number 115859; Model No 00880100100, UDI (01)00889024375901(21)115860, Lot Number 65944750, Serial Number 115860; Model No 00880100100, UDI (01)00889024375901(21)115861, Lot Number 65944750, Serial Number 115861; Model No 00880100100, UDI (01)00889024375901(21)115864, Lot Number 65944750, Serial Number 115864; Model No 00880100100, UDI (01)00889024375901(21)115865, Lot Number 65944750, Serial Number 115865; Model No 00880100100, UDI (01)00889024375901(21)115866, Lot Number 65944750, Serial Number 115866; Model No 00880100100, UDI (01)00889024375901(21)115868, Lot Number 65944750, Serial Number 115868; Model No 00880100100, UDI (01)00889024375901(21)115869, Lot Number 65944750, Serial Number 115869; Model No 00880100100, UDI (01)00889024375901(21)115872, Lot Number 65944750, Serial Number 115872; Model No 00880100100, UDI (01)00889024375901(21)115873, Lot Number 65944750, Serial Number 115873; Model No 00880100100, UDI (01)00889024375901(21)115874, Lot Number 65944750, Serial Number 115874; Model No 00880100100, UDI (01)00889024375901(21)115875, Lot Number 65944750, Serial Number 115875; Model No 00880100100, UDI (01)00889024375901(21)115877, Lot Number 65944750, Serial Number 115877; Model No 00880100100, UDI (01)00889024375901(21)115879, Lot Number 65944752, Serial Number 115879; Model No 00880100100, UDI (01)00889024375901(21)115882, Lot Number 65944752, Serial Number 115882; Model No 00880100100, UDI (01)00889024375901(21)115883, Lot Number 65944752, Serial Number 115883; Model No 00880100100, UDI (01)00889024375901(21)115884, Lot Number 65944752, Serial Number 115884; Model No 00880100100, UDI (01)00889024375901(21)115885, Lot Number 65944752, Serial Number 115885; Model No 00880100100, UDI (01)00889024375901(21)115886, Lot Number 65944752, Serial Number 115886; Model No 00880100100, UDI (01)00889024375901(21)115887, Lot Number 65944752, Serial Number 115887; Model No 00880100100, UDI (01)00889024375901(21)115889, Lot Number 65944752, Serial Number 115889; Model No 00880100100, UDI (01)00889024375901(21)115890, Lot Number 65944752, Serial Number 115890; Model No 00880100100, UDI (01)00889024375901(21)115891, Lot Number 65944752, Serial Number 115891; Model No 00880100100, UDI (01)00889024375901(21)115892, Lot Number 65944752, Serial Number 115892; Model No 00880100100, UDI (01)0088902437… (truncated, 84654 characters total — see the official FDA record for the full value)
Recalling firm:
Zimmer Surgical Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled November 24, 2025

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

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

Recall #:
98022
Lot/product code:
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
Recalling firm:
ICU Medical, Inc.
View official FDA record (opens in a new tab)