The Recall Desk
ModerateFDA (Devices)·Z-1193-2026·Announced 2026-02-04

BEAR implants recalled over an expiration date beyond approved shelf life

Miach Orthopaedics is recalling 284 BEAR Implants because the label carries an expiration date that extends beyond the product's documented and approved shelf life.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 under the minor labeling criterion: the record cites an incorrect expiration date and UDI with no stated consequence or reported harm.

Plain-English summary

The BEAR Implant, model number 1000, is being recalled by Miach Orthopaedics.

The reason given in the enforcement record is an incorrect expiration date on the label that extends beyond the product's documented and approved shelf life. The record states that with an incorrect expiration date, the UDI will also be incorrect.

The record lists 284 units under model 1000, UDI (01)00860002987804(17)260228(10)7011098, lot number 7011098. Distribution was nationwide in the United States across the states listed in the enforcement record. The FDA has classified the action as Class II.

The record cites a printed date and UDI error and states no further consequence or reported injuries. Facilities should quarantine affected stock and follow Miach Orthopaedics' instructions.

The recalled product

Product
Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K;
Manufacturer
Medline Industries, LP
Category
Medical Device — Implant
Hazard
Affected units
857

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Medline Kit SKU ACC010270A: UDI/DI 10889942219827 (EA) 40889942219828 (CS)
  • Lot Number 25LDA153
  • Medline Kit SKU ACC010690: UDI/DI 10195327433307 (EA) 40195327433308 (CS)
  • Lot Number 25LDA088
  • Medline Kit SKU ACC011073: UDI/DI 10198459569333 (EA) 40198459569334 (CS)
  • Lot Number 25LDA072
  • Medline Kit SKU DYNJ00282Q: UDI/DI 10195327412029 (EA) 40195327412020 (CS)
  • Lot Number 25KMC904
  • Lot Number 25LMA071
  • Medline Kit SKU DYNJ0101360K: UDI/DI 10195327662066 (EA) 40195327662067 (CS)
  • Lot Number 25KMC709
  • Medline Kit SKU DYNJ0220136S: UDI/DI 10198459566073 (EA) 40198459566074 (CS)
  • Lot Number 25KMB403
  • Lot Number 25JMF503
  • Medline Kit SKU DYNJ0376635Q: UDI/DI 10198459422591 (EA) 40198459422592 (CS)
  • Lot Number 25KMH121
  • Lot Number 25KMF780
  • Medline Kit SKU DYNJ0460768T: UDI/DI 10198459466809 (EA) 40198459466800 (CS)
  • Lot Number 25KMH789
  • Medline Kit SKU DYNJ0509186J: UDI/DI 10198459117626 (EA) 40198459117627 (CS)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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