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Recalls affecting Alabama

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

16,873 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

View FDA’s announcement (opens in a new tab)
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 21, 2026

5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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

Recall #:
99096
Lot/product code:
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 Lot Number: REKY2412 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 Lot Number: REKY1364 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 Lot Number: RELN0881 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 Lot Number: REKY1381 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 Lot Number: REJZ0927
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 008017410352 Lot Number: REKY1686
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

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

Recall #:
99162
Lot/product code:
1) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025120590; 2) ART1145, UDI-DI: 10653160349259(each), 00653160349252(case), Lot Number: 2025101490; 3) ART155A, UDI-DI: 10653160316459(each), 00653160316452(case), Lot Number: 2025100890; 4) ART1010B, UDI-DI: 10653160353577(each), 00653160353570(case), Lot Number: 2025091590
Recalling firm:
Medline Industries, LP
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.

The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

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

Recall #:
99128
Lot/product code:
Part No.00077407508 UDI-DI 00195226000764 Lot 260504E; Part No. 00077407510 UDI-DI 00195226000665 Lot 260505B; Part No. 00077415004 UDI-DI 00195226000856 Lot 260505A; Part No. 00077415008 UDI-DI 00195226000757 Lot No.260505A; Part No. 00077415010 UDI-DI 00195226000658 Lot 260505C; Part No. 00077430010 UDI-DI 00195226000641 Lot 260505B
Recalling firm:
Instrumentation Laboratory
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Lot Number: REKT1554
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 The Poly Per-Q-Cath Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sarnpling.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 Lot Number: REKV1588 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKX0938 CK000566 Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741108051 Lot Number: REKY1965
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 21, 2026

PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30

Defective container:may contain bottles with incomplete seals

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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-0605-2026
Lot/product code:
BNZ-001921, EXP 04/15/2029
Recalling firm:
Keystone Industries
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 Lot Number: REKY0255
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 21, 2026

Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30

Defective container:may contain bottles with incomplete seals

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-0604-2026
Lot/product code:
BNZ-001921, Exp 04/15/2029
Recalling firm:
Keystone Industries
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

ALL 50 STATES
▸Full report

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

Recall #:
99096
Lot/product code:
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741087110 Lot Number: REKW2449 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741027536 Lot Number: REKV2227
Recalling firm:
Bard Access Systems, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 21, 2026

Papablic Replacement Brush Heads. Model Number: Papablic18B

Potential for brush heads to break.

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

Recall #:
98898
Lot/product code:
Model Number: Papablic18B; Amazon FNSKU: X004LOZKE3; Lot Numbers: PS2509A01, PS2511A01, PS2512A01; Date Codes: 2509, 2511, 2512. The recalled product is limited to Papablic18B replacement brush head packs bearing the above lot numbers/date codes. Products with other lot numbers/date codes are not included in this recall.
Recalling firm:
Papablic Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

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▸Full report

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

Recall #:
99026
Lot/product code:
Product Number; UDI-DI Code; Lot Code: Product number 9323-5333; UDI-DI 04719886908084; Lot number 25FB50 Product number 9323-5334; UDI-DI 04719886908091; Lot number 25FB51
Recalling firm:
United Orthopedic Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

ALL 50 STATES
▸Full report

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

Recall #:
99026
Lot/product code:
Product Number; UDI-DI Code; Lot Code: Product Number 9323-5511; UDI-DI 04719886906929; Lot number 25FB54 Product Number 9323-5512; UDI-DI 04719886906936; Lot number 25FB55 Product Number 9323-5513; UDI-DI 04719886906943; Lot number 25FB56 Product Number 9323-5514; UDI-DI 04719886906950; Lot number 25FB57 Product Number 9323-5515; UDI-DI 04719886906967; Lot number 25FB58 Product Number 9323-5516; UDI-DI 04719886906424; Lot number 25FB59 Product Number 9323-5521; UDI-DI 04719886906974; Lot number 25FB29 Product Number 9323-5522; UDI-DI 04719886906981; Lot number 25FB30 Product Number 9323-5523; UDI-DI 04719886906998; Lot number 25FB31 Product Number 9323-5524; UDI-DI 04719886907001; Lot number 25FB32 Product Number 9323-5525; UDI-DI 04719886907018; Lot number 25FB33 Product Number 9323-5526; UDI-DI 04719886907025; Lot number 25FB34
Recalling firm:
United Orthopedic Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No

Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

ALL 50 STATES
▸Full report

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

Recall #:
99026
Lot/product code:
Product Number; UDI-DI Code; Lot Code: Product number 9323-5335; UDI-DI 04719886906554; Lot number 25FB64 Product number 9323-5337; UDI-DI 04719886906578; Lot number 25FB48 Product number 9323-5339; UDI-DI 04719886906592; Lot number 25FB52 Product number 9323-5336; UDI-DI 04719886906561; Lot number 25FB65 Product number 9323-5338; UDI-DI 04719886906585; Lot number 25FB49 Product number 9323-5340; UDI-DI 04719886906608; Lot number 25FB53
Recalling firm:
United Orthopedic Corp.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

RayCare 2024A SP1. Oncology Information Systems.

Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

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

Recall #:
99141
Lot/product code:
Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
Recalling firm:
RAYSEARCH LABORATORIES AB
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040476 ; UDI-DI (01)00889024682047(17)350531(10)097492 ; Lot Number 097492
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

ARTIS icono floor. Model Number: 11327700.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

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

Recall #:
99079
Lot/product code:
Model Number: 11327700. UDI-DI: 4056869149325. Serial Numbers: 174132, 174128, 174085, 174152, 174056, 174055, 174083, 174121, 174122, 174087, 174044, 174061, 174099, 174058, 174063, 174150, 174126, 174125, 174096, 174145, 174101, 174065, 174076, 174078, 174091, 174149, 174059, 174073, 174081, 174067.
Recalling firm:
Siemens Medical Solutions USA, Inc
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
▸Full report

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
▸Full report

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040242 ; UDI-DI (01)00889024681989(17)350601(10)099471 ; Lot Number 099471 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350614(10)099473 ; Lot Number 099473 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350804(10)099474 ; Lot Number 099474 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350806(10)099475 ; Lot Number 099475
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

ALL 50 STATES
▸Full report

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

Recall #:
99045
Lot/product code:
Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458
Recalling firm:
Zimmer, Inc.
View official FDA record (opens in a new tab)
UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.

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

Recall #:
99034
Lot/product code:
1. Model/REF Number: POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). Pack UDI-DI: 20385081120033. Single Pod UDI-DI: 10385081120036. Lot Numbers: L72514. 2. Model/REF Number: ZXR425 (10-Pack), ZXR420 (Single Pod). Pack UDI-DI: N/A. Single Pod UDI-DI: N/A. Lot Numbers: L72516, L72521. 3. Model/REF Number: ZXP425 (10 Pack), ZXP420 (Single Pod). Pack UDI-DI: 20385081120033. Single Pod UDI-DI: 10385081120036. Lot Numbers: L72515, L72509, L72513, L72511, L72510, L71480, L72514.
Recalling firm:
Insulet Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod).

External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.

ALL 50 STATES
▸Full report

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

Recall #:
99034
Lot/product code:
1. Model/REF Number: POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000051. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11052421, PD1U11012421, PD1U11022421, PD1U02152521, PD1U02192521, PD1U04242522, PD1U10282522, PD1U10292521, PD1U10302521, PD1U10312521, PD1U11032521, PD1U11042521, PD1U01082621. 2. Model/REF Number: POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000020. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11192421, PD1U09102421, PD1U09092421, PD1U09062421, PD1U10242421, PD1U10252421, PD1U10282421, PD1U10292421, PD1U10312421, PD1U11042421. 3. Model/REF Number: BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). Pack UDI-DI: 20385082000020. Single Pod UDI-DI: 10385082000023. Lot Numbers: PD1U11152421, PD1U11182421, PD1U11202421, PD1U09042421, PD1U11132421, PD1U11122421, PD1U11142421, PD1U11152411, PD1U11162421, PD1U04292521, PD1U09032421, PD1U11112421, PD1U04262521. 4. Model/REF Number: BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod). Pack UDI-DI: 20385082000112. Single Pod UDI-DI: 10385082000115. Lot Numbers: PD1U03042521, PD1U09052421, PD1U11072421, PD1U11082421, PD1U03062521, PD1U03032521, PD1U03072521, PD1U02282525, PD1U02282526, PD1U04252521, PD1U11062521, PD1U11072521, PD1U11102521, PD1U11112511, PD1U11112522, PD1U11122521.
Recalling firm:
Insulet Corporation
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UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

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

Recall #:
99045
Lot/product code:
Lot Code: 110040444 ; UDI-DI (01)00889024681903(17)350531(10)097487 ; Lot Number 097487
Recalling firm:
Zimmer, Inc.
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UnclassifiedRisk not yet known
Medical deviceRecalled May 20, 2026

ARTIS icono biplane. Model Number: 11327600.

Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

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

Recall #:
99079
Lot/product code:
Model Number: 11327600. UDI-DI: 4056869063317. Serial Numbers: 184246, 184241, 184086, 184178, 184108, 184099, 184070, 184127, 184095, 184167, 184184, 184205, 184199, 184221, 184126, 184047, 184093, 184044, 184096, 184214, 184100, 184119, 184073, 184188, 184134, 184150, 184081, 184153, 184085, 184243, 184117, 184045, 184159, 184151, 184177, 184079, 184087, 184169, 184116, 184157, 184163, 184123, 184090, 184118, 184140, 184230, 184224, 184195, 184248, 184225, 184190, 184106, 184046, 184078, 184200, 184142, 184138, 184166, 184152, 184113, 184186, 184196, 184105, 184102, 184147, 184120, 184121, 184124, 184211, 184233, 184216, 184050, 184067, 184112, 184122, 184220, 184089, 184097, 184234, 184103, 184098, 184084, 184183, 184179, 184109
Recalling firm:
Siemens Medical Solutions USA, Inc
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